# DEN220027: B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System

- Pathway: De Novo (Direct)
- Applicant: Brahms GmbH, Part of Thermo Fisher Scientific
- Decided: May 18, 2023 after 381 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K241453: Elecsys sFlt-1 and Elecsys PlGF (2025), 0 descendants of its own

## Indications for use
The B·R·A·H·M·S PlGF plus KRYPTOR is to be used in conjunction with the B·R·A·H·M·S sFlt-1 KRYPTOR along with other laboratory tests and clinical assessments to aid in the risk assessment of pregnant women (singleton pregnancies between gestational age 23+0 to 34+6/7 weeks) hospitalized for hypertensive disorders of pregnancy (preeclampsia, chronic hypertension with or without superimposed preeclampsia, or gestational hypertension) for progression to preeclampsia with severe features (as defined by the American College of Obstetricians and Gynecologists (ACOG) guidelines) within 2 weeks of presentation.

Source page: https://510kreport.com/device/DEN220027
Methodology: https://510kreport.com/methodology