{ "release_id": "15708f235d73cd42", "id": "maternal:sflt1-plgf-ratio", "owner": "maternal", "kind": "biomarker", "slug": "sflt1-plgf-ratio", "name": "sFlt-1/PlGF ratio", "aliases": [ "sFlt-1 to PlGF ratio", "soluble fms-like tyrosine kinase-1 to placental growth factor ratio" ], "atlases": [ "maternal" ], "summary_plain": "A blood test result for a pregnant woman: two proteins, sFlt-1 and placental growth factor (PlGF), are measured in the same sample, and the first is divided by the second. The test is used in two different ways in two countries. In the United States, the FDA clears one version as an aid for judging, within two weeks, the risk of pre-eclampsia with severe features (the FDA term) in women already in hospital with high blood pressure, and the FDA regulation for prognostic tests of this kind says they are not intended for diagnosis. In England, NICE recommends two named ratio tests (DELFIA Xpress and Elecsys) and two PlGF-only tests to help rule pre-eclampsia in or out when it is suspected between 20 weeks and 36 weeks and 6 days, and does not recommend a third ratio test, the BRAHMS Kryptor ratio, for routine NHS use. The two uses are not interchangeable.", "summary_technical": "The ratio of soluble fms-like tyrosine kinase-1 (sFlt-1) to placental growth factor (PlGF) measured by a matched pair of immunoassays, in human serum (Elecsys) or in serum or K2-EDTA plasma (KRYPTOR). Interpretation depends on the stated intended use. US: 21 CFR 862.1602 describes a prognostic aid device type for the development or progression of pre-eclampsia and says that device is not intended for diagnosis; the K241453 indication covers singleton pregnancies at 23+0 to 34+6/7 weeks hospitalized for a hypertensive disorder of pregnancy, with progression to pre-eclampsia with severe features within two weeks from testing. England: in NICE HTG630 the Elecsys company labelling is reported to present the test as an aid to diagnosing pre-eclampsia and to predicting it in the short term, with cut-offs that depend on use and stage of pregnancy. A cut-off printed in one document must not be applied to the other document's use. This record gives no cut-off as a general rule.", "editorial_state": "draft", "last_substantive_edit": "2026-10-12", "last_evidence_check": "2026-10-12", "next_review_due": null, "external_ids": [], "navigation": { "maternal": { "life-stage": [ "pregnancy" ] } }, "payload": { "measure": "Ratio of the sFlt-1 concentration to the PlGF concentration in a single sample (serum for the Elecsys pair, serum or K2-EDTA plasma for the KRYPTOR pair), from two paired immunoassays.", "assay_context": "Laboratory immunoassays on an automated analyzer. Roche's K241453 510(k) Summary says values from other manufacturers' assays \"may result in significantly different ratios\" and that only the Elecsys sFlt-1 and Elecsys PlGF assays should be used to calculate the Elecsys ratio. Uses and cut-offs differ by jurisdiction and are kept in separate claims and contexts.", "interpretation_claims": [ "maternal:claim-sflt1-plgf-ratio-us-prognostic-use", "maternal:claim-sflt1-plgf-ratio-nice-rule-in-out-use" ] }, "content_digest": "94e4b0a631747423263f7dd5690a5341a239dfd53285b28ac8ce71c3b62b02b2", "review": { "content_digest": "94e4b0a631747423263f7dd5690a5341a239dfd53285b28ac8ce71c3b62b02b2", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "claims": [ { "release_id": "15708f235d73cd42", "id": "maternal:claim-sflt1-plgf-ratio-nice-rule-in-out-use", "owner": "maternal", "subject_entity_id": "maternal:sflt1-plgf-ratio", "category": "descriptive", "statement": "In NICE HealthTech guidance HTG630, two named ratio tests (DELFIA Xpress sFlt-1/PLGF 1-2-3 ratio and Elecsys immunoassay sFlt-1/PLGF ratio), together with two tests that measure PlGF alone, are recommended to help rule pre-eclampsia in or out in people in whom preterm pre-eclampsia is suspected between 20 weeks and 36 weeks and 6 days of pregnancy. NICE says a third ratio test, the BRAHMS sFlt-1 Kryptor/BRAHMS PLGF plus Kryptor PE ratio, is not one that NICE recommends for routine NHS use (recommendation 1.6). Section 2 of the guidance describes the company labelling of the Elecsys ratio test that NICE assessed. The labelling presents the test as an aid, alongside other clinical information, to diagnosing pre-eclampsia and to predicting it in the short term. NICE says each test is to be used within its manufacturer's stated indications for use, and recommends against using them to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia.", "context": { "id": "maternal:ctx-nice-htg630-suspected-preterm-preeclampsia-20w-36w6d", "label": "Suspected preterm pre-eclampsia, 20 weeks to 36 weeks and 6 days (NICE HTG630)", "recipient": "maternal", "population": "People with suspected preterm pre-eclampsia between 20 weeks and 36 weeks and 6 days of pregnancy. NICE treats a woman who meets only part of the pre-eclampsia criteria as having suspected pre-eclampsia.", "care_setting": "Not stated as a setting. The guidance is for the NHS and describes testing used with standard clinical assessment.", "geography": "England (NHS). NICE's terms and conditions present the information on its websites as support for people in England who make decisions about funding care (clause 6) and say it is not written as a basis for decisions outside the United Kingdom (clause 8). The guidance page states no jurisdiction of its own. The guidance refers to routine use in the NHS.", "life_stage": "Pregnancy, 20 weeks to 36 weeks and 6 days", "gestational_age_min_days": 140, "gestational_age_max_days": 258, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Not applicable (recommendation context)", "eligibility": { "inclusion": [ "Suspected preterm pre-eclampsia between 20 weeks and 36 weeks and 6 days of pregnancy" ], "exclusion": [ "Not stated as an exclusion. Separate recommendations advise against using the tests to guide the decision on whether a planned early birth should be offered to people with preterm pre-eclampsia, and advise using a test once for each episode of suspected preterm pre-eclampsia." ] } }, "evidence_stage": "guidance", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is the NICE use for the NHS only. It differs from the US FDA-cleared use, where the regulation for the prognostic device type says it is not intended for diagnosis. HTG630 section 2 prints company cut-offs by intended use and stage of pregnancy, including 38 or less to rule out pre-eclampsia for one week between week 24 and week 36 plus 6 days. That number must not be read as the US cut-off of 38, which has a different outcome, window and population. No cut-off is recorded here as a rule, because NICE recommends using each test according to its indications for use. NICE gives no strength grade here. This claim does not say the tests perform well, and it records no performance figures.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "2.7, sentence 1", "applicability_note": "NICE HTG630 section 2, cited and linked only. How the Elecsys ratio is formed.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "2.7, sentence 2", "applicability_note": "The company labelling intended use, as described by NICE: to help diagnose pre-eclampsia.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "2.7, sentence 3", "applicability_note": "The company labelling intended use, as described by NICE: short-term prediction.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "context", "locator": "Table 2, Elecsys cut-offs, short-term prediction rows", "applicability_note": "A company cut-off for one use and window. Shown to prevent it being merged with the US cut-off.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "context", "locator": "2.4, sentence 4", "applicability_note": "How NICE describes suspected pre-eclampsia.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "1.1, list of tests", "applicability_note": "The two recommended ratio tests are the DELFIA Xpress and Elecsys tests; two other recommended tests measure PLGF alone.", "snapshot": { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "1.1, note on manufacturers' indications", "applicability_note": "Some manufacturers do not indicate their tests for the whole gestational range.", "snapshot": { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "1.1, note on indications for use", "applicability_note": "Each test is to be used according to its indications for use.", "snapshot": { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "supports", "locator": "1.4", "applicability_note": "Not for decisions about a planned early birth.", "snapshot": { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } }, { "evidence_role": "context", "locator": "1.6, sentence 1", "applicability_note": "NICE does not recommend the BRAHMS Kryptor ratio test for routine NHS use.", "snapshot": { "id": "maternal:nice-htg630-recs-2026-10-11", "retrieved_at": "2026-10-11T19:10:54Z", "content_hash": "a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } } ], "review": { "content_digest": "9f8ba23eada739e0737544ef6688c46a48e1e3b48f3e8f85aa97c06186d28647", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-sflt1-plgf-ratio-nice-rule-in-out-use.json" }, { "release_id": "15708f235d73cd42", "id": "maternal:claim-sflt1-plgf-ratio-us-prognostic-use", "owner": "maternal", "subject_entity_id": "maternal:sflt1-plgf-ratio", "category": "descriptive", "statement": "Under 21 CFR 862.1602, FDA classifies a prognostic test for development or progression of pre-eclampsia as \"an in vitro diagnostic device\" indicated as an aid in the risk assessment for the development or progression of pre-eclampsia, and the regulation says \"This device is not intended for diagnosis of any disease.\" The Elecsys sFlt-1 and PlGF system (K241453) is cleared under this regulation, and the KRYPTOR system (DEN220027) is described in its own claim. The labelling of the Elecsys sFlt-1 and PlGF test, cleared as K241453, applies the ratio to hospitalized women with a singleton pregnancy at 23+0 to 34+6/7 weeks and a hypertensive disorder of pregnancy, to judge whether pre-eclampsia with severe features will develop within two weeks from testing, with clinical assessment and routine laboratory testing. The regulation requires labelling to say a result is not to be used to aid the diagnosis of pre-eclampsia, or decisions about hospital discharge or pregnancy delivery. The cut-off of 38 that Roche's study validated belongs to this use.", "context": { "id": "maternal:ctx-fda-k241453-hospitalized-hdp-singleton-23w0d-34w6d", "label": "Hospitalized for a hypertensive disorder of pregnancy, singleton pregnancy, 23 weeks 0 days to 34 weeks 6 days (US labelling of K241453)", "recipient": "maternal", "population": "Pregnant women with a singleton pregnancy, hospitalized for a hypertensive disorder of pregnancy (pre-eclampsia, chronic hypertension with or without superimposed pre-eclampsia, or gestational hypertension), at 23 weeks 0 days to 34 weeks 6 days.", "care_setting": "Hospital. The indication is for women hospitalized for the disorder.", "geography": "United States (FDA labelling)", "life_stage": "Pregnancy, 23 weeks 0 days to 34 weeks 6 days", "gestational_age_min_days": 161, "gestational_age_max_days": 244, "postnatal_age_min_days": null, "postnatal_age_max_days": null, "gestational_age_status": null, "postnatal_age_status": null, "followup_description": "Two weeks from testing, the window in the indication for developing pre-eclampsia with severe features", "eligibility": { "inclusion": [ "Singleton pregnancy", "Hospitalized for a hypertensive disorder of pregnancy", "In the PRAECIS study that validated the cut-off: age 18 years or older, admitted to the hospital with a hypertensive disorder of pregnancy or developing one while hospitalized" ], "exclusion": [ "Not stated in the parts of the 510(k) summary that were read. The device type is not intended for diagnosis of any disease." ] } }, "evidence_stage": "not_applicable", "certainty": "not_assessed", "certainty_method": null, "limitations": "This is the US use only. The use NICE recommends in England, to help rule pre-eclampsia in or out when it is suspected between 20 weeks and 36 weeks and 6 days, is a separate claim in a separate context. Both documents print a ratio of 38, for different stated uses, outcomes and gestational windows, so no threshold may be carried from one context to the other. Performance figures are in their own claim and come from the submitter's study. This claim describes what the documents say. It does not say which use is clinically better.", "editorial_state": "draft", "checked_at": "2026-10-12", "next_review_due": null, "valid_from": null, "valid_to": null, "citations": [ { "evidence_role": "supports", "locator": "(a) Identification, sentence 1, second part", "applicability_note": "21 CFR 862.1602: the device type is an in vitro diagnostic device.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "(a) Identification, sentence 2", "applicability_note": "21 CFR 862.1602: the device type is an aid in the risk assessment for the development or progression of pre-eclampsia.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "(a) Identification, sentence 3", "applicability_note": "21 CFR 862.1602: not intended for diagnosis of any disease.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "(b)(2)(ii) Limiting statements, lead-in", "applicability_note": "The labelling of a device of this type must carry limiting statements.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "(b)(2)(ii)(B)", "applicability_note": "Limiting statement on diagnosis.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "(b)(2)(ii)(C)", "applicability_note": "Limiting statement on hospital discharge.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "(b)(2)(ii)(D)", "applicability_note": "Limiting statement on pregnancy delivery.", "snapshot": { "id": "maternal:ecfr-21-cfr-862-1602-2026-10-11", "retrieved_at": "2026-10-11T19:14:47Z", "content_hash": "40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1", "source_effective_date": null, "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:ecfr-21-cfr-862-1602", "source_type": "regulator", "title": "21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)", "canonical_url": "https://www.ecfr.gov/api/versioner/v1/full/2026-10-01/title-21.xml?part=862§ion=862.1602", "identifier_namespace": "21-cfr", "identifier_value": "862.1602", "publication_date": null, "publisher": "Office of the Federal Register and U.S. Government Publishing Office (eCFR)", "edition": "eCFR versioner API text for the version dated 2026-10-01, as fetched on 2026-10-11. The first request (mc-ecfr-862-1602-nocompression.xml) returned HTTP 406 because it did not accept compression, and a request for the version dated 2026-10-09 (mc-ecfr-862-1602-retry.xml) returned HTTP 404.", "reuse_basis": "Text of a US federal regulation, 2838 bytes, committed at research/snapshots/mc-ecfr-862-1602-2026-10-01.xml. The GovInfo Public Domain and Copyright Notice (fetched as mc-govinfo-policies.html, sha256 d9e3a2f1cb4486ab4ecc4eff640f94f9a9bb8655ca71ff00694b236e7011ad1c) cites 17 U.S.C. 105, under which copyright protection is not available for any work of the United States Government. This basis rests on the GovInfo notice alone, as for the core copy of 21 CFR 870.1130.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Clearance letter, page 1, reference block", "applicability_note": "K241453 carries regulation 21 CFR 862.1602 and product code QWH.", "snapshot": { "id": "maternal:fda-510k-summary-k241453-2026-10-11", "retrieved_at": "2026-10-11T19:11:38Z", "content_hash": "edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00", "source_effective_date": "2025-02-07", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k241453", "source_type": "regulator", "title": "FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241453", "identifier_namespace": "fda-510k", "identifier_value": "K241453", "publication_date": "2025-02-07", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-11. The openFDA device 510(k) JSON record (meta.last_updated 2026-09-28) gives the decision date, product code and decision. The 510(k) summary PDF (27 pages) holds FDA's clearance letter, the Indications for Use form and Roche's own 510(k) Summary. The accessdata pmn.cfm page was fetched too (fetch-log label mc-fda-pmn-k241453.html) and has no snapshot record. The openFDA classification record for product code QWH was fetched as well (mc-openfda-class-qwh.json) and is not used, because the eCFR text of 21 CFR 862.1602 is the primary source for the device type.", "reuse_basis": "The openFDA license page (fetched as mc-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The FDA website policies page (mc-fda-website-policies.html, sha256 e7cf15d3edf28bd645ce47acd2a96bde8eafab0743981949df0a79019d59a2b2) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mc-openfda-510k-k241453.json; it holds the applicant's business contact name exactly as FDA publishes it. The 510(k) summary PDF is Roche's submission text released by FDA, so only short quotations are used and its bytes are not committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "Indications for Use form", "applicability_note": "The K241453 indication wording, in fragments. Roche's text as released by FDA; short quotation only.", "snapshot": { "id": "maternal:fda-510k-summary-k241453-2026-10-11", "retrieved_at": "2026-10-11T19:11:38Z", "content_hash": "edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00", "source_effective_date": "2025-02-07", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k241453", "source_type": "regulator", "title": "FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241453", "identifier_namespace": "fda-510k", "identifier_value": "K241453", "publication_date": "2025-02-07", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-11. The openFDA device 510(k) JSON record (meta.last_updated 2026-09-28) gives the decision date, product code and decision. The 510(k) summary PDF (27 pages) holds FDA's clearance letter, the Indications for Use form and Roche's own 510(k) Summary. The accessdata pmn.cfm page was fetched too (fetch-log label mc-fda-pmn-k241453.html) and has no snapshot record. The openFDA classification record for product code QWH was fetched as well (mc-openfda-class-qwh.json) and is not used, because the eCFR text of 21 CFR 862.1602 is the primary source for the device type.", "reuse_basis": "The openFDA license page (fetched as mc-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The FDA website policies page (mc-fda-website-policies.html, sha256 e7cf15d3edf28bd645ce47acd2a96bde8eafab0743981949df0a79019d59a2b2) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mc-openfda-510k-k241453.json; it holds the applicant's business contact name exactly as FDA publishes it. The 510(k) summary PDF is Roche's submission text released by FDA, so only short quotations are used and its bytes are not committed.", "public_text": "quote" } }, { "evidence_role": "supports", "locator": "510(k) Summary, 5 Clinical performance evaluation, paragraph 1", "applicability_note": "PRAECIS validated the cut-off of 38 for this use.", "snapshot": { "id": "maternal:fda-510k-summary-k241453-2026-10-11", "retrieved_at": "2026-10-11T19:11:38Z", "content_hash": "edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00", "source_effective_date": "2025-02-07", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:fda-510k-k241453", "source_type": "regulator", "title": "FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)", "canonical_url": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K241453", "identifier_namespace": "fda-510k", "identifier_value": "K241453", "publication_date": "2025-02-07", "publisher": "U.S. Food and Drug Administration", "edition": "Two retrievals on 2026-10-11. The openFDA device 510(k) JSON record (meta.last_updated 2026-09-28) gives the decision date, product code and decision. The 510(k) summary PDF (27 pages) holds FDA's clearance letter, the Indications for Use form and Roche's own 510(k) Summary. The accessdata pmn.cfm page was fetched too (fetch-log label mc-fda-pmn-k241453.html) and has no snapshot record. The openFDA classification record for product code QWH was fetched as well (mc-openfda-class-qwh.json) and is not used, because the eCFR text of 21 CFR 862.1602 is the primary source for the device type.", "reuse_basis": "The openFDA license page (fetched as mc-openfda-license.html, sha256 7fda0041a24f8d7139a1781d4462ae39643a2ee6f3b0f079946c989a8e1982d2) says openFDA content and data are public domain under a CC0 1.0 dedication. The FDA website policies page (mc-fda-website-policies.html, sha256 e7cf15d3edf28bd645ce47acd2a96bde8eafab0743981949df0a79019d59a2b2) says FDA website content is not copyrighted unless otherwise noted. The openFDA JSON is committed at research/snapshots/mc-openfda-510k-k241453.json; it holds the applicant's business contact name exactly as FDA publishes it. The 510(k) summary PDF is Roche's submission text released by FDA, so only short quotations are used and its bytes are not committed.", "public_text": "quote" } }, { "evidence_role": "context", "locator": "Table 2, Elecsys cut-offs, short-term prediction rows", "applicability_note": "A 38 also appears in the NICE table, for a different use and window. Shown to prevent the two being merged.", "snapshot": { "id": "maternal:nice-htg630-tests-2026-10-11", "retrieved_at": "2026-10-11T19:11:18Z", "content_hash": "931c1cb59c943358485d26b1565e4a74b3e83041d38c58e4b0885931afbe151c", "source_effective_date": "2022-07-27", "public_archive_url": null, "source_state": "current" }, "source": { "id": "maternal:nice-htg630", "source_type": "guideline", "title": "PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)", "canonical_url": "https://www.nice.org.uk/guidance/htg630", "identifier_namespace": "nice", "identifier_value": "HTG630", "publication_date": "2022-07-27", "publisher": "National Institute for Health and Care Excellence (NICE)", "edition": "Three pages as shown on 2026-10-11: the Overview, chapter 1 Recommendations and chapter 2 The diagnostic tests. The page header gives the reference number and the publication date. The Overview says diagnostics guidance 49 was migrated to HealthTech guidance 630 with its recommendations and content unchanged. The old DG49 address was fetched too (fetch-log label mc-nice-htg630-dg49.html) and says the guidance itself has not changed; it has no snapshot record.", "reuse_basis": "The page bytes are not committed. Public text is cite_only (Ben's decision of 2026-10-13 (medical-atlas-core issue 2)): public pages state the facts in the atlas's own words, with a citation and a link, and use no NICE wording. NICE reuse terms were read on 2026-10-11 by the setup cluster and are summarised in research/setup/notes.md: the NICE UK Open Content Licence covers use in a UK setting only, international use outside personal research and study needs a licence and a fee, and the NICE terms and conditions make content available for artificial intelligence purposes only through an approval process, a licence and a fee for international use. This pipeline uses AI agents to read the pages, so Ben decided on 2026-10-13 that public pages cite and link NICE and use none of its wording. Cluster C did not read the terms pages again.", "public_text": "cite_only" } } ], "review": { "content_digest": "36734dc4be06bf358dda89060c75e9a2eb4fe823c904a9825f98843dbe448a9b", "current": [], "conflicting": [], "stale": [], "inactive": [] }, "api_path": "api/v1/claims/maternal--claim-sflt1-plgf-ratio-us-prognostic-use.json" } ], "decisions": [], "relationships": { "outgoing": [ { "predicate": "related_to", "label": "Measured in blood tests that NICE and the FDA each describe for pre-eclampsia, for different uses", "clinical_claim_not_fact": false, "other_entity_id": "maternal:preeclampsia", "other_entity_in_atlas": true, "claim_id": null } ], "incoming": [ { "predicate": "measures", "label": "Measured by", "clinical_claim_not_fact": false, "other_entity_id": "maternal:elecsys-sflt1-plgf", "other_entity_in_atlas": true, "claim_id": null }, { "predicate": "measures", "label": "Measured by", "clinical_claim_not_fact": false, "other_entity_id": "maternal:sflt1-plgf-immunoassay", "other_entity_in_atlas": true, "claim_id": null } ] }, "page_path": "biomarkers/sflt1-plgf-ratio/", "context_path": "api/v1/context/maternal--sflt1-plgf-ratio.md" }