# K040455: Linical Uric Acid Calibration Verifiers Levels a - E for Olympus AU Systems

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Mar 5, 2004 after 11 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
CLINIQA LiniCAL TM Uric Acid Calibration Verifiers Levels A - E for Olympus AU Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU SystemsTM for Uric Acid at five useful concentrations.

Source page: https://510kreport.com/device/K040455
Methodology: https://510kreport.com/methodology