# K170652: ARCHITECT B.R.A.H.M.S PCT,  ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls

- Pathway: 510(k) (Traditional)
- Applicant: Fisher Diagnostics
- Decided: Jun 1, 2017 after 90 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 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). Cleared while this submission was under review Summary page 8.

## Indications for use
The ARCHITECT B∙R∙A∙H∙M∙S PCT assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA) on the ARCHITECT iSystem. Used in conjunction with other laboratory findings and clinical assessments, the ARCHITECT B∙R∙A∙H∙M∙S PCT assay is intended for use as an: • Aid in the risk assessment of critically ill patients on their first day of intensive care unit (ICU) admission for progression to severe sepsis and septic shock. • 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. • 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. • Aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis. The ARCHITECT B∙R∙A∙H∙M∙S PCT Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only. The ARCHITECT B∙R∙A∙H∙M∙S PCT Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT iSystem when used for the quantitative determination of procalcitonin (PCT) in human serum and plasma (lithium heparin and K2EDTA). For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K170652
Methodology: https://510kreport.com/methodology