# K992576: Urine Chemistry Control, Level 1

- Pathway: 510(k) (Traditional)
- Applicant: Consolidated Technologies, Inc.
- Decided: Sep 3, 1999 after 32 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
Longest line of descent: 1 generation back to K880496 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K880496: Lyphochek Quantitative Urine Control Normal (1), Bio-Rad (1988) Summary page 1.

## Indications for use
Urine Chemistry Control, Level 1, is a lyophilized human urine based assayed quality control material intended to monitor the performance of urine chemistry test procedures that analyze inorganics, metals, drugs, endocrine hormones and metabolites.

Source page: https://510kreport.com/device/K992576
Methodology: https://510kreport.com/methodology