# K080973: Cliniqa Liquid QC  Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker Control-Low, and Linical Cardiac

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Jun 2, 2008 after 59 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
CLINIQA® Liquid QC TM Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for use as a standard. LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the reportable range. CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for use as a standard.

Source page: https://510kreport.com/device/K080973
Methodology: https://510kreport.com/methodology