# K081908: Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2

- Pathway: 510(k) (Traditional)
- Applicant: Cliniqa Corporation
- Decided: Jan 16, 2009 after 197 days
- Product code: JJW (Urinalysis 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.
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 QCTM DipScopics Unnalysis Control is intended for use as an assayed quality control material for various unnalysis reagent strips, qualitative hCG methods as well as confirmatory tests such as Acetest®, Clinitest®, and Ictotest®. This control is also intended to evaluate microscopic examination test procedures

Source page: https://510kreport.com/device/K081908
Methodology: https://510kreport.com/methodology