# K974337: IL Test Urea Nitrogen

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 17, 1997 after 29 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 K932467 (1993). 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)
- K932467: Ilab 900/1800 Clinical Chemistry System, Instrumentation Laboratory CO (1993) Summary page 1.
- K943595: Serum/Urine Appli Ilab (TM) Clinical Chemistry System, Instrumentation Laboratory CO (1994) Summary page 1.

## Indications for use
IL Test™ Urea Nitrogen is an in vitro diagnostic test for use with Instrumentation Laboratory’s line of clinical chemistry systems in the quantitative determination of urea and urea nitrogen in human serum, plasma or urine by enzyme-coupled urease/GLDH methodology. Increases in serum urea nitrogen (urea) can be a result of kidney dysfunction or urinary tract obstruction'. 'Friedman, R. et al., Effects of Diseases on Clinical Laboratory Tests, Clin. Chem., 26: (4), 1980

Source page: https://510kreport.com/device/K974337
Methodology: https://510kreport.com/methodology