# K101673: Uritek TC-101 Urine Analyzer, Urine Reagent Strips 10, Models TC-101, Urs-10

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Feb 4, 2011 after 234 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K905396 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031947: Bayer Clinitek Status Analyzer, Bayer Healthcare, LLC (2003) Summary page 4.

## Indications for use
The Uritek TC-101 urine analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. The instrument is intended to be used together with the Urine Reagent Strips (URS) 10 as a system for the semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism; kidney and liver function, acid-base balance and bacteriuria.

Source page: https://510kreport.com/device/K101673
Methodology: https://510kreport.com/methodology