CHEK-STIX U.T.I. SELF-TEST

K960888 · Bayer Corp. · JMT · Jul 5, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960888
• Device Name: CHEK-STIX U.T.I. SELF-TEST
• Applicant: Bayer Corp.
• Product Code: JMT · Clinical Chemistry
• Decision Date: Jul 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1510
• Device Class: Class 1

Intended 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.

Device Story

Plastic test strip with two reagent pads; detects nitrite and leukocyte esterase in urine specimens. User dips strip in urine; reagent pads undergo color change (pink/purple) upon reaction. User compares strip color to provided bottle label chart. Used in home setting by lay persons. Output provides qualitative detection of urinary tract infection markers; assists in identifying potential infection; facilitates timely clinical consultation.

Clinical Evidence

Clinical study comparing lay person performance to healthcare professionals. Sample size not specified. Primary endpoint: agreement between user groups. Results: 97% agreement for nitrite test; 85% agreement for WBC test.

Technological Characteristics

Dry reagent strip; colorimetric reaction (diazo) for nitrite and leukocyte esterase. Form factor: plastic strip with two reagent pads. No electronic components or software.

Indications for Use

Indicated for lay persons for the detection of urinary tract infections via testing for nitrite and leukocytes in urine.

Regulatory Classification

Identification

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

Predicate Devices

• MULTISTIX® 2 Reagent Strips for Urinalysis (Bayer Corporation)

Submission Summary (Full Text)

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Bayer Corporation, Business Group Diagnostics
CHEK-STIX U.T.I. Test Strips
510(k) Safety and Effectiveness Summary
Page 1 of 2
JUL - 5 1996

# 510(k) SAFETY AND EFFECTIVENESS SUMMARY

Prepared: June 19, 1996
*K960888*

Submitter: Bayer Corporation, Business Group Diagnostics

Address: 1884 Miles Avenue, P. O. Box 70
Elkhart, IN 46515
[phone]

Contact: Rosanne M. Savol, R.A.C.
Manager, Regulatory Affairs

Device: Trade/Proprietary Name: CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection
Common/Usual Name: Test for nitrite in urine
Test for leukocytes (WBC’s) in urine
Document Control Number: K960888

Classification Information: Division of Clinical Laboratory Devices
Panel - Clinical Chemistry and Toxicology
Classification Codes -- CH(75) JMT [Diazo (Colorimetric), Nitrite (Urinary, Non-Quant.)]
CH(75) LJX (Urine Leukocyte Test)

Predicate Device: MULTISTIX® 2 Reagent Strips for Urinalysis
Manufactured by Bayer Corporation

Device Description: CHEK-STIX U.T.I. Test Strips for the Detection of Urinary Tract Infection is a plastic strip to which is affixed two reagent pads to test for nitrite and leukocytes (WBC’s) in a urine specimen. The product is provided as a carton containing a bottle of five strips and a package insert.

Intended 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.

Revised 6/3/96

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Bayer Corporation, Business Group Diagnostics
CHEK-STIX U.T.I. Test Strips
510(k) Safety and Effectiveness Summary
Page 2 of 2

## Technological Characteristics:

CHEK-STIX U.T.I. Test Strips are dry reagent strips which, when in contact with a urine specimen, reacts with nitrite and leukocyte esterase in the specimen to give a pink and a purple color. The color of the strip is compared to a color chart on the bottle label to obtain the result. CHEK-STIX U.T.I. has the same test pads as are on strips used by doctors and clinical labs.

## Assessment of Performance:

A study was conducted in clinical settings to demonstrate that lay persons can obtain results with CHEK-STIX U.T.I. comparable to results obtained by health care professionals.

Agreement between the two groups was 97% for the nitrite test and 85% for the WBC test.

## Conclusion:

The results of the patient-use evaluation demonstrate that lay persons can use CHEK-STIX U.T.I. Test Strips and obtain results that are in agreement with results obtained by health care professionals. The instructions are simple to understand and afford the home user a way to detect urinary tract infections.

Revised 6/3/96