# K152835: Uritek TC-201 Urine Chemistry Test System

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics, Inc.
- Decided: Mar 7, 2016 after 160 days
- Product code: JFY (Enzymatic Method, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K905396 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091216: Clinitek Status+Analyzer and Clinitek Status Connect System, Models 1780, 1797, Siemens Healthcare Diagnostics (2009) Summary page 5.

## Indications for use
Uritek TC-201 Urine Chemistry Test System consists of Uritek TC-201 Urine Analyzer and Urine Microalbumin Creatinine Strips. The Uritek TC-201 Urine Analyzer is an automated, bench top instrument which is intended for prescription, in vitro diagnostic use only. It is intended for use only at Point-of-Care (POC) sites by professionals. The device is intended to be used together with the Urine Microalbumin Creatinine (UAC) Strips as a system for the semi-quantitative detection of Microalbumin and Creatinine and determination of the albumin to creatinine ratio in urine. Test results may be used in screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage.

Source page: https://510kreport.com/device/K152835
Methodology: https://510kreport.com/methodology