# K960888: Chek-Stix U.T.I. Self-Test

- Pathway: 510(k) (Traditional)
- Applicant: Bayer Corp.
- Decided: Jul 5, 1996 after 123 days
- Product code: JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant))
- Device class: 1
- Regulation: 21 CFR 862.1510
- 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. The FDA summary names its predicate without a number.
- (no number) MULTISTIX® 2 Reagent Strips for Urinalysis: named in the summary without a submission number

## Indications for use
CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is an O.T.C. home use test for nitrite and leukocytes (WBC’s) in urine. It is intended to be used by lay persons to detect urinary tract infections.

Source page: https://510kreport.com/device/K960888
Methodology: https://510kreport.com/methodology