# K181002: Atellica IM BRAHMS Procalcitonin (PCT)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics, Inc.
- Decided: Jul 16, 2018 after 91 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)
- DEN150009: B.R.A.H.M.S PCT sensitive KRYPTOR, Brahms GmbH (2016) Summary page 5.
- K171338: B R A H M S PCT sensitive KRYPTOR, Brahms GmbH (2017) Summary page 5.

## Indications for use
The Atellica® IM BRAHMS Procalcitonin (PCT) assay is for in vitro diagnostic use in the quantitative determination of procalcitonin in human serum and plasma (EDTA, lithium heparin, and sodium heparin) using the Atellica® IM Analyzer. The Atellica IM BRAHMS PCT assay is intended for use, in conjunction with other laboratory findings and clinical assessments, as an aid in: • The risk assessment of critically ill patients on their first day of ICU admission for progression to severe sepsis and septic shock. • 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 percent change in PCT level over time. • 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. • Decision-making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Source page: https://510kreport.com/device/K181002
Methodology: https://510kreport.com/methodology