# K171338: B R A H M S PCT sensitive KRYPTOR

- Pathway: 510(k) (Traditional)
- Applicant: Brahms GmbH
- Decided: May 31, 2017 after 23 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: 3 generations back to K071146 (2007). 4 ancestors in all.
7 later devices descend from it; 6 cite it directly.
0 of 12 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 9.
- K162827: Vidas B.R.a.H.M.S. PCT (PCT), bioMerieux, Inc. (2017) Summary page 9.

## Most influential descendants
- K173927: Elecsys BRAHMS PCT (2018), 1 descendant of its own
- K220262: Dimension EXL LOCI BRAHMS Procalcitonin (PCT) (2022), 0 descendants of its own
- K192815: Elecsys BRAHMS PCT (2020), 0 descendants of its own
- K200236: VITROS BRAHMS PCT Reagent Pack and Calibrators (2020), 0 descendants of its own
- K181002: Atellica IM BRAHMS Procalcitonin (PCT) (2018), 0 descendants of its own

## Indications for use
The B·R·A·H·M·S PCT sensitive KRYPTOR® is an immunofluorescent assay using Time-Resolved Amplified Cryptate Emission (TRACE) technology to determine the concentration of PCT (procalcitonin) in human serum and EDTA or heparin plasma. The B·R·A·H·M·S PCT sensitive KRYPTOR® is intended to be performed on the B·R·A·H·M·S KRYPTOR® analyzer family. Used in conjunction with other laboratory findings and clinical assessments, B·R·A·H·M·S PCT sensitive KRYPTOR® 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 determine the change in PCT level over time as an 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, • to aid in decision making on antibiotic therapy, for inpatients or patients in the emergency department 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), • to aid in decision making on antibiotic discontinuation for patients with suspected or confirmed sepsis.

Source page: https://510kreport.com/device/K171338
Methodology: https://510kreport.com/methodology