# K040887: B-R-a-H-M-S PCT Lia

- Pathway: 510(k) (Traditional)
- Applicant: Brahms Aktiengesellschaft
- Decided: Jan 7, 2005 after 277 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: 1 generation back to DEN030002 (2003). 1 ancestor in all.
2 later devices descend 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)
- DEN030002: Endotoxin Activity Assay (Eaa) Device, Spectral Diagnostics, Inc. (2003). Our reading of the summary gave K021885, which is not in FDA’s 510(k) list. The device the summary names is FDA’s De Novo DEN030002, Endotoxin Activity Assay (Eaa) Device (Spectral Diagnostics, Inc.), granted Jun 16, 2003; older De Novo requests were first filed under a 510(k) number, so this links to the grant.

## Most influential descendants
- K070310: B R a H M S PCT Sensitive Kryptor Test System (2008), 1 descendant of its own
- K240041: IVD CAPSULE PSP; abioSCOPE (2024), 0 descendants of its own

## Indications for use
The B.R-A.H.M-S PCT LIA is an immunoluminometric assay (ILMA) used to determine the concentration of PCT (procalcitonin) in human serum and plasma. The B.R.A.H-M-S PCT LIA 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/K040887
Methodology: https://510kreport.com/methodology