# K022491: Linical Hscrp Calibration Verifiers Levels a-E for Olympus AU Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Aug 27, 2002 after 29 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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
LiniCAL™ hsCRP Calibration Verifiers Levels A - E for Olympus AU Systems™ is intended for use as an assayed quality control material for analysis.

Source page: https://510kreport.com/device/K022491
Methodology: https://510kreport.com/methodology