JIR · Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1645 · Class 1
Overview
| Product Code | JIR |
|---|---|
| Device Name | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) |
| Regulation | 21 CFR 862.1645 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
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.
Recent Cleared Devices (20 of 38)
Showing 20 most recent of 38 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K222921 | Minuteful-kidney test | Healthy.Io, Ltd. | Sep 8, 2023 | SESE |
| K210069 | Minuteful - kidney test | Healthy.Io, Ltd. | Jul 6, 2022 | SESE |
| K150330 | Mission Urinalysis Reagent Strips (Microalbumin/Creatinine) | ACON Laboratories, Inc. | Apr 30, 2015 | SESE |
| K061419 | TECO MICROALBUMIN 2-1 COMBO STRIPS | Teco Diagnostics | Jan 26, 2007 | SESE |
| K022538 | IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25 | Diagnostic Chemicals, Ltd. (Usa) | Aug 23, 2002 | SESE |
| K001810 | URISITE URINE COLLECTION KIT FOR MICROALBUMIN/CREATININE TESTING | Flexsite Diagnostics, Inc. | Aug 14, 2000 | SESE |
| K994035 | IMMUNODIP URINARY ALBUMIN SCREEN, MODEL 790-01, 790-15 | Diagnostic Chemicals , Ltd. | Feb 1, 2000 | SESE |
| K992257 | NEW MULTIPLES REAGENT STRIPS | Bayer Corp. | Nov 24, 1999 | SESE |
| K991315 | MICROALBUSTIX REAGENT STRIPS (OTC) | Bayer Corp. | Nov 12, 1999 | SESE |
| K983774 | UALB | Abbott Laboratories | Jan 28, 1999 | SESE |
| K972960 | HEALTH CHECK URI-TEST PROTEIN IN URINE | Tcpi, Inc. | Oct 7, 1998 | SESE |
| K982219 | MICROALBUSTIX REAGENT STRIPS | Bayer Corp. | Aug 12, 1998 | SESE |
| K972337 | DCLARE IMMUNODIP STICKFOR MICROALBUMINURIA | Diagnostic Chemicals , Ltd. | Aug 8, 1997 | SESE |
| K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY | American Laboratory Products Co., Ltd. | Apr 8, 1997 | SESE |
| K963142 | DCA 2000 + MICROALBUMIN/CREATININE ASSAY | Bayer Corp. | Sep 27, 1996 | SESE |
| K951222 | TOTAL PROTEIN (URINE) | Randox Laboratories, Ltd. | Apr 24, 1996 | SESE |
| K960274 | ORGENTEC MICRO-ALBUMIN PIN EIA ASSAY | Orgentec | Mar 29, 1996 | SESE |
| K955438 | URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION) | Teco Diagnostics | Jan 29, 1996 | SESE |
| K954346 | CHEMSTRIP MICRAL URINE TEST STRIPS | Boehringer Mannheim Corp. | Oct 26, 1995 | SESE |
| K932950 | TINA-QUANT MICROALBUMIN | Boehringer Mannheim Corp. | Feb 10, 1995 | SESE |
Top Applicants
- Bayer Corp. — 4 clearances
- Boehringer Mannheim Corp. — 3 clearances
- Biotrol, USA, Inc. — 2 clearances
- Diagnostic Chemicals , Ltd. — 2 clearances
- Exocell, Inc. — 2 clearances
