# K992800: Sigma Diagnostics Infinity Bun Reagent, Models 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Diagnostics, Inc.
- Decided: Sep 28, 1999 after 40 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 K971477 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971477: Urea (Urea Nitrogen) - Incorporating Dynamic Stabilization Technology (DST), Trace America, Inc. (1997) Summary page 1.

## Indications for use
The Sigma Diagnostics INFINITY™ BUN Reagent is a device intended to measure urea nitrogen (an end product of nitrogen metabolism) in serum, plasma or urine. Measurements obtained by the device are used in the diagnosis and treatment of certain renal and metabolic diseases.

Source page: https://510kreport.com/device/K992800
Methodology: https://510kreport.com/methodology