Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart B — Clinical Chemistry Test Systems](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems) → [21 CFR 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635) → JGQ — Turbidimetric, Total Protein

# JGQ · Turbidimetric, Total Protein

_Clinical Chemistry · 21 CFR 862.1635 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ

## Overview

- **Product Code:** JGQ
- **Device Name:** Turbidimetric, Total Protein
- **Regulation:** [21 CFR 862.1635](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1635)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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.

## Recent Cleared Devices (13 of 13)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K131051](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K131051.md) | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | Hitachi Chemical Diagnostics, Inc. | Jun 7, 2013 | SESE |
| [K072638](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K072638.md) | ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 | Roche Diagnostics Corp. | Oct 19, 2007 | SESE |
| [K071239](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K071239.md) | TOTAL PROTEIN URINE/CSF GEN.3 | Roche Diagnostics | Sep 14, 2007 | SESE |
| [K981295](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K981295.md) | UPRO | Abbott Laboratories | Oct 1, 1998 | SESE |
| [K981682](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K981682.md) | UPRO | Abbott Laboratories | Sep 21, 1998 | SESE |
| [K925794](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K925794.md) | TRACE MICROPROTEIN REAGENT | Trace America, Inc. | Mar 29, 1993 | SESE |
| [K913615](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K913615.md) | URINARY/CSF PROTEIN | Boehringer Mannheim Corp. | Sep 13, 1991 | SESE |
| [K903914](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K903914.md) | PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK | Baxter Healthcare Corp | Oct 3, 1990 | SESE |
| [K901083](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K901083.md) | EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 | Em Diagnostic Systems, Inc. | Apr 16, 1990 | SESE |
| [K863478](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K863478.md) | CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 | Em Diagnostic Systems, Inc. | Oct 29, 1986 | SESE |
| [K842134](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K842134.md) | SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY | Somas Medical Industries, Inc. | Jul 6, 1984 | SESE |
| [K822231](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K822231.md) | ACA URINARY PROTEIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Sep 30, 1982 | SESE |
| [K780110](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ/K780110.md) | CSF TOTAL PROTEIN TEST SET #0340 | Stanbio Laboratory | Mar 3, 1978 | SESE |

## Top Applicants

- Abbott Laboratories — 2 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
- Baxter Healthcare Corp — 1 clearance
- Boehringer Mannheim Corp. — 1 clearance
- E.I. Dupont DE Nemours & Co., Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JGQ)

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