# K241453: Elecsys sFlt-1 and Elecsys PlGF

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Feb 7, 2025 after 261 days
- Product code: QWH (Prognostic Test For Development Or Progression Of Preeclampsia)
- Device class: 2
- Regulation: 21 CFR 862.1602
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN220027 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN220027: B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System, Brahms GmbH, Part of Thermo Fisher Scientific (2023) Summary page 5.

## Indications for use
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.

Source page: https://510kreport.com/device/K241453
Methodology: https://510kreport.com/methodology