# K042625: Quikread CRP Calibrator Set

- Pathway: 510(k) (Traditional)
- Applicant: Orion Diagnostica, OY
- Decided: Nov 18, 2004 after 52 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- 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
The Orion Diagnostica QuikRead CRP Verification Set is intended for verification of calibration and method validation of the QuikRead CRP System. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K042625
Methodology: https://510kreport.com/methodology