# K162827: Vidas B.R.a.H.M.S. PCT (PCT)

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Feb 23, 2017 after 139 days
- Product code: PRI (Procalcitonin Assay)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K071146 (2007). 3 ancestors in all.
21 later devices descend from it; 6 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)
- K160911: Vidas B.R.a.H.M.S. PCT (PCT), bioMerieux, Inc. (2016) Summary page 4.

## Most influential descendants
- 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
- K181599: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application (2019), 2 descendants of its own
- K222332: MeMed BV (2023), 1 descendant of its own

## Indications for use
VIDAS® B·R·A·H·M·S PCT™ (PCT) is an automated test for use on the instruments of the VIDAS® family for the determination of human procalcitonin in human serum or plasma (lithium heparinate) using the ELFA (Enzyme-Linked Fluorescent Assay) technique. Used in conjunction with other laboratory findings and clinical assessments, VIDAS® B·R·A·H·M·S PCT™ is intended for use as follows: • 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, • to aid in assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with severe sepsis or septic shock in the ICU or when obtained in the emergency department or other medical wards prior to ICU admission, using a change in PCT level over time, • to aid in decision making on antibiotic therapy for patients with suspected or confirmed lower respiratory tract infections (LRTI) – defined as community-acquired pneumonia (CAP), acute bronchitis, and acute exacerbation of chronic obstructive pulmonary disease (AECOPD) – in an inpatient setting or an emergency department, • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Source page: https://510kreport.com/device/K162827
Methodology: https://510kreport.com/methodology