# K971477: Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST)

- Pathway: 510(k) (Traditional)
- Applicant: Trace America, Inc.
- Decided: May 27, 1997 after 34 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.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K070146: Abx Pentra Glucose HK CP, Urea CP, Uric Acid CP (2007), 3 descendants of its own
- K081276: Abx Pentra Glucose HK CP, Abx Pentra Uric Acid CP, Abx Pentra Urine Control L/H (2008), 2 descendants of its own
- K183375: Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode (2019), 0 descendants of its own
- K100263: Elitech Clinical Systems Phosphorus, Uric Acid Mono SL and Urea UV SL Reagents (2011), 0 descendants of its own
- K992800: Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P (1999), 0 descendants of its own

## Indications for use
Intended for the In Vitro, quantitative determination of Urea (Urea Nitrogen) in human serum and urine for clinical diagnosis. “This Urea (Urea Nitrogen) test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.”

Source page: https://510kreport.com/device/K971477
Methodology: https://510kreport.com/methodology