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Paired sFlt-1 and PlGF immunoassays

Two blood tests run on the same sample in a laboratory machine, one for sFlt-1 and one for placental growth factor (PlGF), with the result reported as the ratio of the two. Different companies build the pair in different ways. This page describes the method, not any one company's product, and not whether any use of the result is recommended.

  • Technology
  • In this atlas

Overview

Technical summary

Quantitative immunoassays for sFlt-1 and PlGF, reported as the sFlt-1/PlGF ratio, in human serum (Elecsys) or in serum or K2-EDTA plasma (KRYPTOR). Two detection methods appear in the sources read. The Roche Elecsys pair uses electrochemiluminescence (ECLIA) on cobas e analyzers. The B·R·A·H·M·S KRYPTOR pair uses Time-Resolved Amplified Cryptate Emission (TRACE) technology. In the US, tests of this kind that are indicated as a prognostic aid are classified under 21 CFR 862.1602 as a prognostic test for development or progression of pre-eclampsia, Class II with special controls, and the regulation says such a device is "not intended for diagnosis of any disease". De Novo request DEN220027, for the KRYPTOR system, was granted under the same regulation number and product code (QWH). NICE HTG630 reports that the company labelling presents the Elecsys ratio test as an aid to diagnosing pre-eclampsia. Both statements are shown here and this record does not resolve them. NICE assessed named products under its own indications in HTG630.

How it works

Paired quantitative immunoassays (the Elecsys assays employ a sandwich principle), one for sFlt-1 and one for PlGF, run on the same sample (serum for Elecsys, serum or K2-EDTA plasma for KRYPTOR) on an automated analyzer, with the ratio calculated from the two results. Detection is by electrochemiluminescence (Elecsys) or by Time-Resolved Amplified Cryptate Emission (B·R·A·H·M·S KRYPTOR).

Strengths

  • The K241453 summary gives total assay times of 18 minutes for the Elecsys assays and 9 minutes for the B·R·A·H·M·S KRYPTOR assays.

Limitations

  • 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. This record does not extend that statement to other ratios.
  • In the US, 21 CFR 862.1602 says a prognostic test of this device type is "not intended for diagnosis of any disease", and its labelling must carry limiting statements, including that a result is not to be used to aid decisions about hospital discharge or pregnancy delivery. NICE HTG630 reports that the company labelling presents the Elecsys ratio test as an aid to diagnosing pre-eclampsia. The two statements differ and this record does not resolve them.

Required infrastructure

  • Elecsys: cobas e immunoassay analyzers
  • B·R·A·H·M·S KRYPTOR: the manufacturer's KRYPTOR analyzer

Claims and evidence

Context 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
23 weeks 0 days (161 days) to 34 weeks 6 days (244 days)
Postnatal age
Not reported
Follow-up
Two weeks from testing, the window in the indication for developing pre-eclampsia with severe features
Eligibility: 3 inclusion criteria; 1 exclusion criterion
Included
  • 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
Excluded
  • Not stated in the parts of the 510(k) summary that were read. The device type is not intended for diagnosis of any disease.

  • Regulatory Evidence stage not applicable Certainty not assessed

    FDA granted De Novo request DEN220027 for the B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, from Brahms GmbH, part of Thermo Fisher Scientific, on 2023-05-18. The FDA record carries product code QWH and 21 CFR 862.1602, the regulation for a prognostic test for development or progression of pre-eclampsia, which is Class II with special controls. FDA's later 510(k) summary for the Elecsys test names this KRYPTOR system as its predicate device.

    Applies to Maternal
    • 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.
    • Hospital. The indication is for women hospitalized for the disorder.
    • United States (FDA labelling)
    • Pregnancy, 23 weeks 0 days to 34 weeks 6 days
    • Gestational age 23 weeks 0 days to 34 weeks 6 days
    • Postnatal age Not reported
    Follow-up Two weeks from testing, the window in the indication for developing pre-eclampsia with severe features
    Certainty method
    Not assessed
    Limitations
    A De Novo grant is not a recommendation to use the test. NICE HTG630 recommendation 1.6 does not recommend the BRAHMS KRYPTOR ratio test for routine NHS use, so a US grant and an English statement of non-recommendation can both hold. No product record for the KRYPTOR system exists, so no regulatory decision record is written for it. The decision summary PDF was fetched, but its scanned text has character errors in trade names, so the facts here come from the openFDA record, the denovo.cfm page and the eCFR text. The FDA context of the Elecsys clearance is reused only because this claim concerns the same device type, although the KRYPTOR indication differs from the Elecsys one. Roche's K241453 510(k) Summary prints the KRYPTOR indication in Table 1, predicate column. It reads "within 2 weeks of presentation" where the Elecsys indication reads "within two weeks from testing", it refers to "as defined by American College of Obstetricians and Gynecologists guidelines" for severe features, and it accepts "human serum and plasma (K2 EDTA)" where the Elecsys indication names human serum. The De Novo decision summary was not used for this indication.
    Last checked
    2026-10-12
    Next evidence check due
    Not scheduled
    Sources and citations (16)

    1. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      results[0].k_number
      How it applies
      The De Novo number as openFDA records it.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    2. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      results[0].decision_date
      How it applies
      The decision date.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    3. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      results[0].decision_code
      How it applies
      The decision code DENG.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    4. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      results[0].device_name
      How it applies
      The device name as FDA records it.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    5. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      results[0].product_code
      How it applies
      The product code.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      bf1f58d99ebe7cfcfd2785421eb073851fab2fc8b5bb4dacf2d0e89edb5be37e
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    6. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      Decision field
      How it applies
      The accessdata page states the decision as granted.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      57eea5005cef94c47b8914a4b55b54d12d81c152b8b4be04944b3a04add929cd
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    7. Supports FDA De Novo request DEN220027, B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (Brahms GmbH, part of Thermo Fisher Scientific)

      Regulator · U.S. Food and Drug Administration · Edition Two retrievals on 2026-10-11. The openFDA device 510(k) endpoint returns the De Novo record too (meta.last_updated 2026-09-28), with the decision date and the decision code DENG and a decision description of Unknown. The accessdata denovo.cfm page says granted. The decision summary PDF was fetched (fetch-log label mc-fda-denovo-summary-den220027.pdf) and has no snapshot record, because its text layer is scanned and has character errors in trade names. · fda-de-novo: DEN220027

      Locator
      Classification fields
      How it applies
      The product code on the De Novo page.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      57eea5005cef94c47b8914a4b55b54d12d81c152b8b4be04944b3a04add929cd
      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-den220027.json; it holds the requester's business contact name exactly as FDA publishes it. The denovo.cfm page bytes are not committed.

    8. Supports 21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)

      Regulator · 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. · 21-cfr: 862.1602

      Locator
      Section heading
      How it applies
      The regulation number and its name.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1
      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.

    9. Supports 21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR)

      Regulator · 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. · 21-cfr: 862.1602

      Locator
      (b) Classification, sentence 1
      How it applies
      Class II with special controls.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1
      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.

    10. Supports FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      510(k) Summary, submitter table, predicate devices row
      How it applies
      K241453 names the KRYPTOR system, DEN220027, as its predicate.
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

    11. Background PLGF-based testing to help diagnose suspected preterm pre-eclampsia (NICE HealthTech guidance HTG630, formerly diagnostics guidance DG49)

      Guideline · 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. · Published 2022-07-27 · nice: HTG630

      Locator
      1.6, sentence 1
      How it applies
      NICE does not recommend the BRAHMS ratio test for routine NHS use.
      Retrieved
      Source effective date
      2022-07-27
      Source state
      Current
      Snapshot hash
      a398cf1b5677008d605646e1ca3792bb0a883ee77eec80f55a16e0f02251d7be
      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.

    12. Supports FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell
      How it applies
      The KRYPTOR system as printed in Roche's K241453 comparison table: automated TRACE immunofluorescent assays.
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

    13. Supports FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell, hospitalized population (text order without -layout)
      How it applies
      The KRYPTOR indication population: women hospitalized for hypertensive disorders of pregnancy.
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

    14. Supports FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, end of intended use cell (text order without -layout)
      How it applies
      The KRYPTOR time window, "within 2 weeks of presentation", and its reference to the American College of Obstetricians and Gynecologists definition.
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

    15. Supports FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      510(k) Summary, Table 1 (summary pp. 5 to 6, PDF pp. 9 to 10), predicate column, intended use cell, PlGF assay sample matrix (text order without -layout)
      How it applies
      The KRYPTOR PlGF assay accepts human serum and plasma (K2 EDTA).
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

    16. Background FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics)

      Regulator · 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. · Published 2025-02-07 · fda-510k: K241453

      Locator
      Indications for Use form, second sentence, third part
      How it applies
      The Elecsys wording for the outcome window, for comparison with the KRYPTOR wording.
      Retrieved
      Source effective date
      2025-02-07
      Source state
      Current
      Snapshot hash
      edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00
      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.

Record details

Record id
maternal:sflt1-plgf-immunoassay
Content hash
9e664e57af2c5389bcb1278ce1d94aec06053e2ce57de5918463aa31422810a2