# K022232: Cliniqa Liquid-QC HCG Control Level 1, 2, and 3

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Aug 1, 2002 after 22 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K121237: Beta HCG Control Level 1 Beta HCG Control Level 2 Beta HCG Control Level 3 Beta HCG Calibration Verification Controls LE (2012), 1 descendant of its own
- K133002: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (2015), 0 descendants of its own

## Indications for use
CLINIQA Liquid-QCTMhCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.

Source page: https://510kreport.com/device/K022232
Methodology: https://510kreport.com/methodology