# K030705: Cliniqa Liquid QC Tumor Marker Control Level 1, Level 2, Level 3, and Tri Level

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Mar 26, 2003 after 20 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
CLlNlQA Liquid QCTMTumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis

Source page: https://510kreport.com/device/K030705
Methodology: https://510kreport.com/methodology