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Elecsys sFlt-1 and Elecsys PlGF (Roche)

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.

Also called Elecsys immunoassay sFlt-1/PLGF ratio

  • Product
  • In this atlas

Overview

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.

Product details

Type
Diagnostic
Model or formulation
Elecsys sFlt-1 and Elecsys PlGF immunoassays (ECLIA) for cobas e immunoassay analyzers, with the sFlt-1/PlGF ratio
Version
Elecsys sFlt-1 and Elecsys PlGF as cleared in the United States under 510(k) K241453 (decision 2025-02-07). This is the US labelling only. The labelling that NICE HTG630 assessed is not shown to be the same.

Intended-use sources

  1. 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
    Whole source
    How it applies
    Source of the stated intended use
    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.

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 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.

    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
    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
    Next evidence check due
    Not scheduled
    Sources and citations (7)

    1. 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
      results[0].decision_date
      How it applies
      The decision date in the openFDA record.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      226daf5ac68fa70fb9c7b92eaea124452c9281d5fc313480099427453ac5126d
      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.

    2. 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
      results[0].decision_description
      How it applies
      The decision, Substantially Equivalent.
      Retrieved
      Source effective date
      Not reported
      Source state
      Current
      Snapshot hash
      226daf5ac68fa70fb9c7b92eaea124452c9281d5fc313480099427453ac5126d
      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.

    3. 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
      Clearance letter, page 1, paragraph 1
      How it applies
      A 510(k) premarket notification, with a finding of substantial equivalence for the stated indications.
      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.

    4. 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
      Clearance letter, page 1, reference block
      How it applies
      Regulation, regulatory class and product code.
      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.

    5. 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
      Indications for Use form
      How it applies
      The indication wording, split into fragments of at most 24 words. Roche's text as released by FDA; short quotation only.
      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.

    6. 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
      510(k) Summary, submitter table, predicate devices row
      How it applies
      The predicate device named in the summary.
      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.

    7. 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
      (a) Identification, sentence 3
      How it applies
      21 CFR 862.1602 says the device type is not intended for diagnosis of any disease.
      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.

  • Description Evidence stage unknown Certainty not assessed

    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%.

    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
    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
    Next evidence check due
    Not scheduled
    Sources and citations (7)

    1. 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, 5 Clinical performance evaluation, paragraph 1
      How it applies
      What PRAECIS validated, as Roche's summary states it.
      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.

    2. 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
      510(k) Summary, 5 Clinical performance evaluation, paragraph 2
      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.
      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.

    3. 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, 5 Clinical performance evaluation, paragraph 3
      How it applies
      The summary's statement that the predictive-value criteria were met.
      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.

    4. 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
      Table 15, count cells (PDF p. 25, summary p. 21)
      How it applies
      Counts above and at or below the cut-off, by outcome.
      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.

    5. 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
      Table 15, sensitivity, specificity and NPV cells
      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.
      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.

    6. 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
      Table 15, PPV, accuracy, LR- and LR+ cells
      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.
      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.

    7. 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
      Table 15, prevalence cell
      How it applies
      Prevalence (%) of pre-eclampsia with severe features in the study population.
      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.

Authorization

Regulatory decision: Elecsys sFlt-1 and Elecsys PlGF (Roche)

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
Authority
U.S. Food and Drug Administration
Decision
Clearance,
Pathway
510(k)
Submission
K241453
Product code
QWH
Device class
Class II
Jurisdiction
United States
Product version
Elecsys sFlt-1 and Elecsys PlGF, for cobas e analyzers, as cleared under K241453
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.
Basis
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.

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.

A regulatory decision is separate from a guideline recommendation and from payment coverage.

Clinical links

Each link reports what one cited claim says about one population. "Evaluated for" means studied, not shown to work. These links do not show that anything is effective or right for you.

Record details

Record id
maternal:elecsys-sflt1-plgf
Content hash
b755c2f8a94b2fced0187f0c499f676de5a36b430630ea66c5c3d8a9835e29c3