510(k) · Cleared
ClearedElecsys sFlt-1 and Elecsys PlGF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · QWH Prognostic Test For Development Or Progression Of Preeclampsia
Cleared on Feb 7, 2025 as substantially equivalent to DEN220027 (Brahms GmbH, Part of Thermo Fisher Scientific, 2023) after a 261-day review. Its family tree reaches back 1 generation to 2023.
- Decided
- Feb 7, 2025
- Review
- 261 days
- Class
- Class II
- Product code
- QWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220027 (2023). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220027 B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemBrahms GmbH, Part of Thermo Fisher Scientific · 2023
- This deviceK241453 Elecsys sFlt-1 and Elecsys PlGFRoche Diagnostics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System | Brahms GmbH, Part of Thermo Fisher Scientific | 2023 | — |
| 0 (this device) | K241453 | Elecsys sFlt-1 and Elecsys PlGF | Roche Diagnostics | 2025 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN220027 | B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test SystemSummary page 5…preeclampsia Product Codes, QWH, 21CFR862.1602 Regulation Numbers Predicate Devices B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System (DEN220027) Establishment Registration Roche Diagnostics GmbH Mannheim, Germany: 9610126 Roche Diagnostics Gm… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All QWH devicesQWH Prognostic Test For Development Or Progression Of Preeclampsia: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QWH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QWH
Too few QWH 510(k)s in any year since 2007 to give a median.
Recalls per year · QWH
No recall names QWH since 2007.
Adverse event reports per year · QWH
2in 2025
MAUDE reports naming product code QWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Immunoassays for the in vitro quantitative determination of the soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio in human serum. The sFlt-1/PlGF ratio is indicated as an aid in the risk assessment of pregnant women, with a singleton pregnancy (23+0 to 34+6/7 weeks’ gestation) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational…
Read the full statement (100 words)
Immunoassays for the in vitro quantitative determination of the soluble fms-like tyrosine kinase-1/placental growth factor (sFlt-1/PlGF) ratio in human serum.
The sFlt-1/PlGF ratio is indicated as an aid in the risk assessment of pregnant women, with a singleton pregnancy (23+0 to 34+6/7 weeks’ gestation) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension), to develop preeclampsia with severe features within two weeks from testing. The sFlt-1/PlGF ratio should be used in conjunction with clinical assessment and routine laboratory testing.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241453: Elecsys sFlt-1 and Elecsys PlGF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241453
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026