# K003400: CRP HS Test System

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics Corp.
- Decided: May 10, 2001 after 190 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.
12 later devices descend from it; 2 cite it directly.
0 of 16 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
- K042485: Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) (2004), 7 descendants of its own
- K103557: Diazyme HS CRP Assay Kit / Calibrator Set / Control Set (2011), 3 descendants of its own
- K032336: Tina-Quant CRP (Latex) (2003), 3 descendants of its own
- K083444: C-Reactive Protein (Latex) (2009), 2 descendants of its own
- K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments (2006), 2 descendants of its own

## Indications for use
For the quantitative determination of C-reactive protein in human serum and plasma. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.

Source page: https://510kreport.com/device/K003400
Methodology: https://510kreport.com/methodology