JGQ · Turbidimetric, Total Protein
Clinical Chemistry · 21 CFR 862.1635 · Class 2
Overview
| Product Code | JGQ |
|---|---|
| Device Name | Turbidimetric, Total Protein |
| Regulation | 21 CFR 862.1635 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Special Controls
*Classification.* Class II (special 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 |
|---|---|---|---|---|
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | Hitachi Chemical Diagnostics, Inc. | Jun 7, 2013 | SESE |
| K072638 | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Roche Diagnostics Corp. | Oct 19, 2007 | SESE |
| K071239 | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics | Sep 14, 2007 | SESE |
| K981295 | UPRO | Abbott Laboratories | Oct 1, 1998 | SESE |
| K981682 | UPRO | Abbott Laboratories | Sep 21, 1998 | SESE |
| K925794 | TRACE MICROPROTEIN REAGENT | Trace America, Inc. | Mar 29, 1993 | SESE |
| K913615 | URINARY/CSF PROTEIN | Boehringer Mannheim Corp. | Sep 13, 1991 | SESE |
| K903914 | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Baxter Healthcare Corp | Oct 3, 1990 | SESE |
| K901083 | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Em Diagnostic Systems, Inc. | Apr 16, 1990 | SESE |
| K863478 | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Em Diagnostic Systems, Inc. | Oct 29, 1986 | SESE |
| K842134 | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | Jul 6, 1984 | SESE |
| K822231 | ACA URINARY PROTEIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Sep 30, 1982 | SESE |
| K780110 | CSF TOTAL PROTEIN TEST SET #0340 | Stanbio Laboratory | Mar 3, 1978 | SESE |
Top Applicants
- Em Diagnostic Systems, Inc. — 2 clearances
- Abbott Laboratories — 2 clearances
- Trace America, Inc. — 1 clearance
- Stanbio Laboratory — 1 clearance
- Somas Medical Industries, Inc. — 1 clearance
