# K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Apr 27, 2011 after 146 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: 4 generations back to K895880 (1989). 7 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive), Roche Diagnostics Corp. (2004) Summary page 3.

## Most influential descendants
- K160712: VITROS Chemistry Products hsCRP Reagent (2017), 1 descendant of its own
- K191993: Yumizen C1200 CRP (2019), 0 descendants of its own
- K121558: Diazyme Hscrp Poc Test Kit (2012), 0 descendants of its own

## Indications for use
The Diazyme high sensitivity C-reactive protein (hsCRP) assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on automated clinical chemistry 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 assay calibrator set is intended for use in the calibration of the C-reactive protein (CRP) assay. For in vitro diagnostic use only. The Diazyme hsCRP assay control set is intended for use as quality controls for the Diazyme hsCRP assay. For in vitro diagnostic use only.

Source page: https://510kreport.com/device/K103557
Methodology: https://510kreport.com/methodology