# K061182: Cliniqa Liquid QC Lipid Control Levels 1 & 2;Linical Lipid Calibration Verifiers Levels a-E for Olympus AU Systems;Qalib

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: May 25, 2006 after 28 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K132031: Afinion Lipid Panel and Afinion Lipid Panel Control (2014), 0 descendants of its own

## Indications for use
CLINIQA Liquid QC Lipid Controls Levels 1 and 2 are intended for use as assayed quality control material for Apolipoprotein A-1, Apolipoprotein B, Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride analysis. CLINIQA LiniCAL Lipid 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 Systems for Cholesterol (total), High Density Lipoprotein, Low Density Lipoprotein and Triglyceride at five useful concentrations. CLINIQA QALIBRATE - Lipid Calibrator is intended for use in assay method calibration for clinical chemistry analyzers listed in the product insert.

Source page: https://510kreport.com/device/K061182
Methodology: https://510kreport.com/methodology