# K070310: B R a H M S PCT Sensitive Kryptor Test System

- Pathway: 510(k) (Traditional)
- Applicant: Brahms Aktiengesellschaft
- Decided: Mar 31, 2008 after 424 days
- Product code: NTM (Antigen, Inflammatory Response Marker, Sepsis)
- Device class: 2
- Regulation: 21 CFR 866.3210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN030002 (2003). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040887: B-R-a-H-M-S PCT Lia, Brahms Aktiengesellschaft (2005) Summary page 1.

## Most influential descendants
- K240041: IVD CAPSULE PSP; abioSCOPE (2024), 0 descendants of its own

## Indications for use
The B.R.A.H.M.S PCT sensitive KRYPTOR® is designed for automated detection of PCT (procalcitonin) in human serum or plasma (EDTA, heparin) samples by the immunofluorescent B.R.A.H.M.S PCT sensitive KRYPTOR® assay. The B.R.A.H.M.S PCT sensitive KRYPTOR® is intended for use in conjunction with other laboratory findings and clinical assessments 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.

Source page: https://510kreport.com/device/K070310
Methodology: https://510kreport.com/methodology