# K011596: Urea Nitrogen (Bun) Liquid Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Jas Diagnostic, Inc.
- Decided: Jul 17, 2001 after 54 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Roche Diagnostics BUN (Urea Nitrogen) Reagent for the Cobas Mira analyzers: named in the summary without a submission number
- (no number) Pointe Scientific Urea Nitrogen (BUN) Reagent (generic): named in the summary without a submission number

## Most influential descendants
- K070704: Trilogy Analyzer (2007), 0 descendants of its own

## Indications for use
Intended for the In Vitro, guantitative determination of urea nitrogen (BUN) in human serum on automated chemistry analyzers. Urea Nitrogen measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K011596
Methodology: https://510kreport.com/methodology