# K200236: VITROS BRAHMS PCT Reagent Pack and Calibrators

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Feb 25, 2020 after 26 days
- Product code: PMT (Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens)
- 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: 4 generations back to K071146 (2007). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K171338: B R A H M S PCT sensitive KRYPTOR, Brahms GmbH (2017) Summary page 7.

## Indications for use
For in-vitro diagnostic use only. For the quantitative measurement of procalcitonin (PCT) in human serum and plasma (lithium heparin and EDTA) using the VITROS 3600 Immunodiagnostic System. Used in conjunction with other laboratory findings and clinical assessments, the VITROS B•R•A•H•M•S PCT test 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/K200236
Methodology: https://510kreport.com/methodology