# K053104: Dimension Cardiophase High Sensitivity C-Reactive Protein Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Dec 23, 2005 after 49 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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 K964527 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964527: N Rheumatology Standard SL, Behring Diagnostics, Inc. (1997) Summary page 2.

## Indications for use
The Dimension® CCRP Calibrator is an in vitro diagnostic product intended to be used to calibrate the Dimension® CardkoPlhase high sensitivity C-reactive protein (Cat. No. RF434) method for the Dimension® clinical chemistry system with the heterogeneous immunoasay module. This product was designed to meet the needs of users to assure accurate results over the assay range of this method.

Source page: https://510kreport.com/device/K053104
Methodology: https://510kreport.com/methodology