# K972960: Health Check Uri-Test Protein in Urine

- Pathway: 510(k) (Traditional)
- Applicant: Tcpi, Inc.
- Decided: Oct 7, 1998 after 422 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
UriTest- Protein in Urine is a non-quantitative screening test to identify protein in urine. Protein in urine can be associated with renal, kidney or bladder disease.

Source page: https://510kreport.com/device/K972960
Methodology: https://510kreport.com/methodology