QWHClass II

Prognostic Test For Development Or Progression Of Preeclampsia

Clinical Chemistry · 21 CFR 862.1602

A prognostic test for development or progression of preeclampsia is an in vitro diagnostic device intended to measure one or more analytes obtained from human samples. A prognostic test for development or progression of preeclampsia is indicated as an aid in the risk assessment for the development or progression of preeclampsia. This device is not intended for diagnosis of any disease.

MDR events2All time

Recalls1All time

Registered firms3Currently listed

510(k) clearances2All time

Recent MDR events

2 adverse event reports on file

Event type breakdown

Malfunction2

Most-reported manufacturers

Roche Diagnostics2

Recalls

1 recall events for this product code

Brahms GmbH
Open, ClassifiedApr 8, 2026
B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in vitro diagnostic test for Placental Growth Factor
Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.
Z-1795-2026 · View FDA record ↗

Registered firms

3 firms currently registered for this product code

510(k) clearances

2 clearances for this product code