# K033908: N High Sensitivity CRP

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 22, 2004 after 36 days
- Product code: NQD (Cardiac 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: 1 generation back to K991385 (1999). 1 ancestor in all.
23 later devices descend from it; 11 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991385: Dade Behring N High Sensitivity CRP Assay, Dade Behring, Inc. (1999) 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
- 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
- K212559: CardioPhase® hsCRP (2022), 1 descendant of its own

## Indications for use
N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using BNTM Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Source page: https://510kreport.com/device/K033908
Methodology: https://510kreport.com/methodology