# K071146: Vidas B.R.a.H.M.S. PCT Assay

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Oct 11, 2007 after 170 days
- Product code: NTM (Antigen, Inflammatory Response Marker, Sepsis)
- Device class: 2
- Regulation: 21 CFR 866.3210
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
24 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) BRAHMS PCT LIA Assay: named in the summary without a submission number

## Most influential descendants
- K160911: Vidas B.R.a.H.M.S. PCT (PCT) (2016), 22 descendants of its own
- K162827: Vidas B.R.a.H.M.S. PCT (PCT) (2017), 21 descendants of its own
- K171338: B R A H M S PCT sensitive KRYPTOR (2017), 7 descendants of its own
- K210254: MeMed BV (2021), 3 descendants of its own
- K220991: IntelliSep test (2022), 2 descendants of its own

## Recalls of this device
- Nov 9, 2022 · Class II · Z-0868-2023: As the temperature and time out of range was exceeded, product performances cannot be guaranteed

## Indications for use
VIDASC BRAHMS PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma (lithium heparin) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. The VIDAS BRAHMS PCT assay is intended for use in conjunction with other laboratory findings and clinical assessments to aid in the risk assessment of critically ill patients on their first day of ICU admission, for progression to severe sepsis and septic shock.

Source page: https://510kreport.com/device/K071146
Methodology: https://510kreport.com/methodology