JIQ · Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Clinical Chemistry · 21 CFR 862.1645 · Class 1
Overview
| Product Code | JIQ |
|---|---|
| Device Name | Turbidimetric 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 (13 of 13)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K141925 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics Operations (Rdo) | Dec 9, 2014 | SESE |
| K013643 | AUSAM TOTAL ALBUMIN ASSAY | Ausam Biotecthnologies, Inc. | Aug 14, 2003 | SESE |
| K991800 | HEMOCHEK URINE COLLECTION KIT | Osborn Group, Inc. | Sep 24, 1999 | SESE |
| K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT | Diagnostic Specialties | Sep 2, 1997 | SESE |
| K965035 | IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT | Beckman Instruments, Inc. | Apr 17, 1997 | SESE |
| K944664 | WAKO MICRO-ALBUMIN B/WAKO MICRO ALBUMIN CALIBRATOR | Wako Chemicals USA, Inc. | Feb 7, 1995 | SESE |
| K936202 | URINARY ALBUMIN TEST PACK | Dupont Medical Products | May 9, 1994 | SESE |
| K935662 | SYNERMED IR 500 CHEMISTRY ANALYZER | Synermed, Inc. | Apr 26, 1994 | SESE |
| K903123 | RAICHEM(TM) SPIA(TM) MICROALBULMIN REAGENT | Reagents Applications, Inc. | Sep 14, 1990 | SESE |
| K902216 | WAKO(TM) MICRO-ALBUMIN | Wako Chemicals USA, Inc. | Jun 18, 1990 | SESE |
| K895883 | BECKMAN MA MICROALBUMIN REAGENT KIT | Beckman Instruments, Inc. | Dec 27, 1989 | SESE |
| K870516 | ALBUMIN SCREEN TEST | Sclavo, Inc. | Oct 20, 1987 | SESE |
| K842915 | SULFOSALICYLIC ACID, 3% W/V | E K Ind., Inc. | Aug 10, 1984 | SESE |
Top Applicants
- Beckman Instruments, Inc. — 2 clearances
- Wako Chemicals USA, Inc. — 2 clearances
- Ausam Biotecthnologies, Inc. — 1 clearance
- Diagnostic Specialties — 1 clearance
- Dupont Medical Products — 1 clearance
