# K981123: UREA

- Pathway: 510(k) (Traditional)
- Applicant: Trace Scientific, Ltd.
- Decided: Apr 24, 1998 after 28 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- 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 K771923 (1977). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954000: Roche Reagent for Bun, Roche Diagnostic Systems, Inc. (1995) Summary page 2.
- K771923: Fastchem Bun, Boehringer Mannheim Corp. (1977) Summary page 2.

## Indications for use
The Urea Nitrogen assay is used for the quantitation of urea nitrogen in human serum, plasma, or urine. Measurements obtained by this device are used in diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K981123
Methodology: https://510kreport.com/methodology