# K030768: Cliniqa Liquid QC Cardiac Marker Control Levels 1, 2 & 3, Tri-Level

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Mar 21, 2003 after 10 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Jul 19, 2012 · Class III · Z-0192-2013: Abbott Point of Care (APOC) has determined that for the Cliniqa Liquid QC Cardiac Marker Control for i-STAT Level 1 (List #06F12-09; Lot Number 071039); i-STAT Level 2 (List #06F12-10; Lot Number 0810

## Indications for use
CLlNlQA Liquid QCTMCardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.

Source page: https://510kreport.com/device/K030768
Methodology: https://510kreport.com/methodology