JMT · Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Clinical Chemistry · 21 CFR 862.1510 · Class 1
Overview
| Product Code | JMT |
|---|---|
| Device Name | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) |
| Regulation | 21 CFR 862.1510 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251800 | Healgen® URS Test Strips | Healgen Scientific,, LLC | Dec 23, 2025 | SESE |
| K252607 | AllTest Urinary Tract Infection Test | Hangzhou AllTest Biotech Co., Ltd. | Oct 30, 2025 | SESE |
| K242767 | Safecare Urinary Tract Infection Test | Safecare Biotech (Hangzhou) Co., Ltd. | Jan 10, 2025 | SESE |
| K170118 | Scanostics UTI Check Application Test System | Teco Diagnostics | Sep 21, 2017 | SESE |
| K100024 | TECO DIAGNOSTICS UTI DETECTION STRIPS | Teco Diagnostics | Feb 17, 2011 | SESE |
| K993850 | URINALYSIS REAGENT STRIPS (10 PARAMETERS) | International Newtech Development, Inc. | Jan 3, 2000 | SESE |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | Ameritek, Inc. | Sep 1, 1999 | SESE |
| K954685 | URITEST - NITRITE IN URINE TEST | Tcpi, Inc. | Jul 22, 1996 | SESE |
| K960888 | CHEK-STIX U.T.I. SELF-TEST | Bayer Corp. | Jul 5, 1996 | SESE |
| K953672 | FIRST CHOICE URINARY TRACT INFECTION TEST STRIPS | Polymer Technology Intl. | Jul 1, 1996 | SESE |
| K875248 | BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS | Bioscan Instruments, Inc. | Feb 24, 1988 | SESE |
| K855238 | BIOTEL (TM)/UTI | American Diagnostic Corp. | May 9, 1986 | SESE |
| K840828 | KYOTEST 8V | Kyoto Diagnostics, Inc. | May 14, 1984 | SESE |
Top Applicants
- Teco Diagnostics — 2 clearances
- Tcpi, Inc. — 1 clearance
- Safecare Biotech (Hangzhou) Co., Ltd. — 1 clearance
- Polymer Technology Intl. — 1 clearance
- Kyoto Diagnostics, Inc. — 1 clearance
