# K061802: Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp Control Low, Hscrp 1 Control High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 11, 2006 after 76 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: 2 generations back to K991385 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033908: N High Sensitivity CRP, Dade Behring, Inc. (2004) Summary page 1.
- K964527: N Rheumatology Standard SL, Behring Diagnostics, Inc. (1997) Summary page 1.
- K962373: N/T Rheumatology Control SL/1 and SL/2, Behring Diagnostics, Inc. (1996) Summary page 1.

## Indications for use
The CardioPhase®hsCRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and plasma by means of particle enhanced immunonephelometry on the Dimension Vista TM System. High sensitivity CRP measurements may be used for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals and as an independent risk marker for the identification and stratification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, 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. Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the high sensitivity C-reactive protein (hsCRP) method on the Dimension VistaTM System. hsCRP Control L and H are for use as assayed intralaboratory quality controls for the assessment of precision and analytical bias in determination of C-reactive protein (CRP) on the Dimension Vista TM System.

Source page: https://510kreport.com/device/K061802
Methodology: https://510kreport.com/methodology