# K173683: LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Feb 27, 2018 after 88 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: 4 generations back to K954418 (1995). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162827: Vidas B.R.a.H.M.S. PCT (PCT), bioMerieux, Inc. (2017) Summary page 5.
- K141463: Liason XL1,25 Dihydroxyvitamin D; Control Set, Calibration Verifiers, DiaSorin, Inc. (2014) Summary page 9.

## Indications for use
The LIAISON® B.R.A.H.M.S PCT® II GEN assay uses chemiluminescence immunoassay (CLIA) technology for the in vitro quantitative determination of Procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, LIAISON® B.R.A.H.M.S PCT® II GEN 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. The LIAISON® Control B.R.A.H.M.S PCT® II GEN (level 1 and level 2) are intended for use as assayed quality control samples to monitor the performance and reliability of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN controls have not been established with any other assay or instrument platform different from the LIAISON® Analyzer. The LIAISON® B.R.A.H.M.S PCT® II GEN Verifiers (four levels) are assayed quality control materials intended in the quantitative verification of calibration and reportable range of the LIAISON® BRAHMS PCT® II GEN assay. The performance characteristics of LIAISON® BRAHMS PCT® II GEN calibration verifiers have not been established in connection with any other assay or instrument platforms different from the LIAISON® Analyzer.

Source page: https://510kreport.com/device/K173683
Methodology: https://510kreport.com/methodology