# K160712: VITROS Chemistry Products hsCRP Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Ortho Clinical Diagnostics
- Decided: Jul 14, 2017 after 486 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.
1 later device descends from it; 1 cites it directly.
0 of 10 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 4.

## Most influential descendants
- K191993: Yumizen C1200 CRP (2019), 0 descendants of its own

## Indications for use
For in vitro diagnostic use only. Rx Only. VITROS Chemistry Products hsCRP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure C-reactive protein (CRP) in human serum and plasma. CRP is used to evaluate conditions thought to be associated with inflammation in otherwise healthy individuals.

Source page: https://510kreport.com/device/K160712
Methodology: https://510kreport.com/methodology