# K061825: Dimension Vista  CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Sep 6, 2006 after 70 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 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 CRP method is an in vitro diagnostic test for the quantitative measurement of C-reactive protein (CRP) in human serum and heparinized plasma by means of particle enhanced immunonephelometry on the Dimension Vista TMSystem. 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, and inflammatory disorders. Protein 2 Calibrator is an in vitro diagnostic product for the calibration of the C-reactive protein (CRP) method on the Dimension VistaTM System. Protein 2 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 VistaTM System.

Source page: https://510kreport.com/device/K061825
Methodology: https://510kreport.com/methodology