# K073277: Roche-Creactive Protein (Latex)

- Pathway: 510(k) (Special)
- Applicant: Roche Diagnostics Corp.
- Decided: Mar 6, 2008 after 106 days
- Product code: DCN (System, Test, C-Reactive Protein)
- 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: 2 generations back to K895880 (1989). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981897: Roche Cobas Integra Alkaline Phosphatase Ifcc Liquid Reagent Cassette, Roche Cobas Integra Pancreatic a-Amylase Eps Reae, Roche Diagnostic Systems, Inc. (1998) Summary page 1.

## Most influential descendants
- K171498: MSD CRP Assay Kit and MESO SECTOR S 700 Instrument (2018), 0 descendants of its own
- K113809: Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP) (2012), 0 descendants of its own

## Indications for use
In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS iNTEGRA systems. In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Source page: https://510kreport.com/device/K073277
Methodology: https://510kreport.com/methodology