# K060322: Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry Control, Level 1 and 2 Unassayed

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Mar 21, 2006 after 40 days
- Product code: JIT (Calibrator, Secondary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: 2 (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
- Jun 1, 2008 · Not classified · Z-2204-2008: Defective software chip may cause the system to fail and lock up.
- Mar 30, 2007 · Not classified · Z-0079-2008: System Lock-Up: Software anomalies could cause product failure during use, or on start-up. System transitions to a safe "soft-lock" state.

## Indications for use
CLINIQA Dry QCTM Chemistry Control, Levels 1 and 2 (Assayed), is intended for use as an assayed quality control material. Two levels of the control are provided. CLINIQA Dry QC TM Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided. CLINIQA QALIBRATE TM - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers.

Source page: https://510kreport.com/device/K060322
Methodology: https://510kreport.com/methodology