# K052679: Cliniqa Liquid QC Bilirubin Controls Levels 1, 2 & 3; Cliniqa Linical Bilirubin Calibration Verifiers Levels a-E

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Nov 18, 2005 after 51 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. The FDA summary names no predicate by number.

## Indications for use
CLINIQA Liquid QCTM Bilirubin Controls Levels 1, 2 & 3 are intended for use as an assayed quality control material. Three assayed levels of Total and Direct Bilirubin are provided. CLINIQA LiniCALTM Bilirubin Calibration Verifiers Levels A - E for Olympus AU SystemsTM are assayed, liquid, quality control products which may be used to evaluate the performance of the Olympus AU SystemsTM for Total and Direct Bilirubin at five useful concentrations.

Source page: https://510kreport.com/device/K052679
Methodology: https://510kreport.com/methodology