# K121558: Diazyme Hscrp Poc Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Sep 21, 2012 after 115 days
- Product code: DCK (C-Reactive Protein, Antigen, Antiserum, And Control)
- Device class: 2
- Regulation: 21 CFR 866.5270
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K895880 (1989). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set, Diazyme Laboratories (2011) Summary page 1.

## Indications for use
The Diazyme high sensitivity C-reactive protein (hsCRP) POC Test Kit is for the in vitro quantitative determination of C-reactive protein (CRP) in human venous whole blood on SMART analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. For in vitro diagnostic use only. The Diazyme hsCRP POC control set is intended for use as quality controls for the Diazyme hsCRP POC Test Kit. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K121558
Methodology: https://510kreport.com/methodology