# K991385: Dade Behring N High Sensitivity CRP Assay

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Oct 25, 1999 after 187 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
No predicates in its family tree.
32 later devices descend from it; 8 cite it directly.
0 of 33 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033908: N High Sensitivity CRP (2004), 23 descendants of its own
- 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
- K053603: C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments (2006), 2 descendants of its own
- K041799: Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17, Vitros Chemistry Products FS (2004), 2 descendants of its own

## Indications for use
The Dade Behring N High Sensitivity CRP assay is an in vitro diagnostic test for the quantitative determination of C-reactive protein in human serum as well as heparin- and EDTA-plasma by means of particle-enhanced immunonephelometry using Dade Behring Nephelometer Systems. 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/K991385
Methodology: https://510kreport.com/methodology