# K131600: Urs-2GP (Glucose Protein) Urine Strips

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: May 29, 2014 after 360 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: 1 generation back to K940469 (1994). 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)
- K940469: Urine Reagent Strip-3 Parameters, Teco Diagnostics (1994) Summary page 1.

## Indications for use
The URS-2GP (Glucose Protein) Urine Strips are visually read, semi-quantitative tests for the detection of glucose and protein in urine and are intended for prescription home use. Test results may provide information regarding the status of carbohydrate metabolism and kidney function.

Source page: https://510kreport.com/device/K131600
Methodology: https://510kreport.com/methodology