# K022176: Orion Diagnostica Ultrasensitive CRP Kit, Model 68025, & Orion Diagnostica Ultrasensitive CRP Control, Model 68257

- Pathway: 510(k) (Traditional)
- Applicant: Orion Diagnostica, Div. Orion Corp.
- Decided: Dec 3, 2002 after 153 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Orion Diagnostica High Sensitivity CRP (HS-CRP) is an in vitro diagnostic assay intended for the quantification of low concentrations (ca. 0.25 - 10.0 mg/l) of C-reactive protein (CRP) in human serum or plasma (EDTA or heparin) by means of particle enhanced immunoturbidimetry using a Hitachi 911 or 917 analyzer. The 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/K022176
Methodology: https://510kreport.com/methodology