# K981918: UREA

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jul 28, 1998 after 57 days
- Product code: CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen)
- Device class: 2
- Regulation: 21 CFR 862.1770
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K771923 (1977). 1 ancestor in all.
1 later device descends 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)
- K771923: Fastchem Bun, Boehringer Mannheim Corp. (1977) Summary page 2.

## Most influential descendants
- K203771: Urea Nitrogen2 (2022), 0 descendants of its own

## Recalls of this device
- Oct 3, 2011 · Not classified · Z-0189-2012: The reagents are being recalled due to particulate matter in some of the reagent cartridges. The particulate matter has been identified as Aureobasidium fungus species.

## 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/K981918
Methodology: https://510kreport.com/methodology