# Elecsys sFlt-1 and Elecsys PlGF (Roche) Product · id `maternal:elecsys-sflt1-plgf` · Maternal & Newborn Atlas · release `15708f235d73cd42` (public) > General information from published sources, not medical advice, and not reviewed by clinicians. Check the cited source before relying on anything here. The atlas's own text and curation may be reused under Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0, https://creativecommons.org/licenses/by-nc/4.0/): credit the atlas, and do not use it commercially. See the atlas About page. Text quoted from a source stays under that source's own terms, given as the source's reuse\_basis. The atlas's reuse terms do not cover it. The downloads list each quotation with its source in third\_party\_quotations. Also called: Elecsys immunoassay sFlt-1/PLGF ratio Browse, life stage: Pregnancy ## In plain language A pair of blood tests from Roche Diagnostics, run in a laboratory, whose results are combined into the sFlt-1/PlGF ratio. In the United States the FDA cleared it in February 2025 as an aid in judging whether a woman already in hospital with high blood pressure in pregnancy will develop pre-eclampsia with severe features (the FDA term) within two weeks. In England, NICE has recommended this ratio test, among others, to help rule pre-eclampsia in or out when it is suspected. The US and English uses are described separately, and the sources read do not show that the UK labelling and the US labelling are the same. ## Technical summary Applicant: Roche Diagnostics, Indianapolis (FDA 510(k) record). Electrochemiluminescence immunoassays (ECLIA) on cobas e analyzers. US labelling, as cleared under 510(k) K241453 on 2025-02-07: an aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks hospitalized for a hypertensive disorder of pregnancy, to develop pre-eclampsia with severe features within two weeks from testing, used with clinical assessment and routine laboratory testing; the regulation for the prognostic device type says it is not intended for diagnosis. The PRAECIS study validated a cut-off of 38 for that use only. NICE HTG630 recommends the Elecsys immunoassay sFlt-1/PLGF ratio under its own indications for use, and its section 2 reports that the company labelling it assessed presents the test as an aid to diagnosing pre-eclampsia and to predicting it in the short term, which differs from the US labelling and which this record does not equate with it. The same HTG630 table prints a ratio of 38 for short-term prediction between week 24 and week 36 plus 6 days, a different use and gestational window from the US one. ## Claims, with the population each applies to ## 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 ### FDA cleared Elecsys sFlt-1 and Elecsys PlGF under 510(k) K241453 on 2025-02-07 for use as an aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks who are hospitalized for a hypertensive disorder of pregnancy (pre-eclampsia, chronic hypertension with or without superimposed pre-eclampsia, or gestational hypertension). The aid is for judging whether pre-eclampsia with severe features will develop within two weeks from testing. The ratio is to be used in conjunction with clinical assessment and routine laboratory testing. The FDA regulation for this type of device says the device is not intended for diagnosis of any disease. - Category: Regulatory - Evidence stage: Evidence stage not applicable - Certainty: Certainty not assessed - Applies to: 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 - Limitations: Clearance means FDA found the device substantially equivalent to a predicate, here the B·R·A·H·M·S KRYPTOR system granted under De Novo request DEN220027. It is not an approval and not an FDA recommendation to use the test for any individual woman. The cleared use is narrow: hospitalized women, a singleton pregnancy, 23+0 to 34+6/7 weeks and a two-week outlook. It does not cover diagnosis. The labelling rules in the regulation say a result is not to be used to aid decisions about hospital discharge or pregnancy delivery. Do not apply this claim to the NICE use in England or to other populations. Only the indication wording and the clearance facts were read, not the full device labelling. - Last checked: 2026-10-11 - Sources: 1. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: results\[0\].decision\_date. Retrieved 2026-10-11T19:11:37Z. Source state: Current. Snapshot hash: 226daf5ac68fa70fb9c7b92eaea124452c9281d5fc313480099427453ac5126d. How it applies: The decision date in the openFDA record. 2. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: results\[0\].decision\_description. Retrieved 2026-10-11T19:11:37Z. Source state: Current. Snapshot hash: 226daf5ac68fa70fb9c7b92eaea124452c9281d5fc313480099427453ac5126d. How it applies: The decision, Substantially Equivalent. 3. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Clearance letter, page 1, paragraph 1. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: A 510(k) premarket notification, with a finding of substantial equivalence for the stated indications. 4. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Clearance letter, page 1, reference block. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: Regulation, regulatory class and product code. 5. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Indications for Use form. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: The indication wording, split into fragments of at most 24 words. Roche's text as released by FDA; short quotation only. 6. Background: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: 510(k) Summary, submitter table, predicate devices row. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: The predicate device named in the summary. 7. Supports: 21 CFR 862.1602, Prognostic test for development or progression of preeclampsia (eCFR) (Regulator, 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.) Locator: (a) Identification, sentence 3. Retrieved 2026-10-11T19:14:47Z. Source state: Current. Snapshot hash: 40d9dddc624d5ae8c365a5a4d95a64b105d43a43041133af9144573c4af440e1. How it applies: 21 CFR 862.1602 says the device type is not intended for diagnosis of any disease. ### Roche's 510(k) summary for K241453 reports the PRAECIS study, which validated a cut-off of 38 for the Elecsys sFlt-1/PlGF ratio as an aid in judging which hospitalized pregnant women with a hypertensive disorder would develop pre-eclampsia with severe features within two weeks of testing. Of 556 women, 186 developed it and 370 did not. Sensitivity was 91.40% (95% confidence interval 86.41 to 95.00) and specificity 77.30% (72.68 to 81.47). The negative predictive value was 94.70% (91.54 to 96.94) and the positive predictive value 66.93% (60.77 to 72.68). The prevalence in the study was 33.45%. - Category: Description - Evidence stage: Evidence stage unknown - Certainty: Certainty not assessed - Applies to: 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 - Limitations: These figures are the submitter's, from one study reported in a regulatory summary. No peer-reviewed paper on PRAECIS was read. The predictive values depend on the 33.45% prevalence of pre-eclampsia with severe features in this hospitalized population and would differ in other populations. In the table, 84 women above the cut-off did not develop pre-eclampsia with severe features within two weeks, and 16 women at or below it did. The summary says the performance criteria for negative and positive predictive value were met. The summary does not state the criteria, the study design, the sites or the dates, or how the outcome was judged. The cut-off of 38 here belongs to the US prognostic use only. The table values were checked against the page image of the PDF. - Last checked: 2026-10-12 - Sources: 1. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: 510(k) Summary, 5 Clinical performance evaluation, paragraph 1. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: What PRAECIS validated, as Roche's summary states it. 2. Background: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: 510(k) Summary, 5 Clinical performance evaluation, paragraph 2. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: The study population: women aged 18 or older at 23+0 to 34+6/7 weeks who were admitted with, or developed in hospital, a hypertensive disorder of pregnancy. 3. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: 510(k) Summary, 5 Clinical performance evaluation, paragraph 3. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: The summary's statement that the predictive-value criteria were met. 4. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Table 15, count cells (PDF p. 25, summary p. 21). Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: Counts above and at or below the cut-off, by outcome. 5. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Table 15, sensitivity, specificity and NPV cells. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: Values with 95% confidence intervals. Text order as extracted by pdftotext without -layout; the cell layout was confirmed on the page image. 6. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Table 15, PPV, accuracy, LR- and LR+ cells. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: The first value and interval of this block is the positive predictive value. Accuracy and likelihood ratios are in the same cells and are not used here. 7. Supports: FDA 510(k) premarket notification K241453, Elecsys sFlt-1 and Elecsys PlGF (Roche Diagnostics) (Regulator, 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.) Locator: Table 15, prevalence cell. Retrieved 2026-10-11T19:11:38Z. Source state: Current. Snapshot hash: edc99e5f8d778ceb857c5c649899e2ef4469ca6b919ee6e47f4e9a07b9662f00. How it applies: Prevalence (%) of pre-eclampsia with severe features in the study population. ## Guidance, authorization and access ### Regulatory decision `maternal:regdec-fda-k241453` - Product: Elecsys sFlt-1 and Elecsys PlGF (Roche) (`maternal:elecsys-sflt1-plgf`) - Authority: U.S. Food and Drug Administration (`core:fda`) - Decision: Clearance, 2025-02-07 - Product version: Elecsys sFlt-1 and Elecsys PlGF, for cobas e analyzers, as cleared under K241453 - Pathway: 510(k) - Submission: K241453 - Product code: QWH - Device class: II - Indication: An aid in the risk assessment of pregnant women with a singleton pregnancy at 23+0 to 34+6/7 weeks who are hospitalized for a hypertensive disorder of pregnancy, to develop pre-eclampsia with severe features within two weeks from testing, used in conjunction with clinical assessment and routine laboratory testing. The regulation for the device type says it is not intended for diagnosis of any disease. - Jurisdiction: United States - Applies to: 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 - Basis: claim `maternal:claim-fda-k241453-indication` ## Connected pages - Uses paired electrochemiluminescence immunoassays: Paired sFlt-1 and PlGF immunoassays (`maternal:sflt1-plgf-immunoassay`) - Reports the sFlt-1/PlGF ratio: sFlt-1/PlGF ratio (`maternal:sflt1-plgf-ratio`) - PRAECIS cut-off of 38 for pre-eclampsia with severe features within two weeks in hospitalized women, from the US 510(k) summary; not a diagnostic use: Pre-eclampsia (`maternal:preeclampsia`) [a claim, not a settled fact; see claim `maternal:claim-praecis-k241453-performance` and its context] ## Provenance Content hash: b755c2f8a94b2fced0187f0c499f676de5a36b430630ea66c5c3d8a9835e29c3 Last substantive edit: 2026-10-12 Evidence last checked: 2026-10-12