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 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035) → CJW — Bromcresol Purple Dye-Binding, Albumin

# CJW · Bromcresol Purple Dye-Binding, Albumin

_Clinical Chemistry · 21 CFR 862.1035 · Class 2_

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

## Overview

- **Product Code:** CJW
- **Device Name:** Bromcresol Purple Dye-Binding, Albumin
- **Regulation:** [21 CFR 862.1035](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/862.1035)
- **Device Class:** 2
- **Review Panel:** [Clinical Chemistry](/submissions/CH)
- **3rd-party reviewable:** yes

## Identification

An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

## Classification Rationale

Class II.

## Recent Cleared Devices (18 of 18)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K203530](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K203530.md) | Albumin BCP2 | Abbott Ireland Diagnostics Division | Mar 18, 2022 | SESE |
| [K193001](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K193001.md) | Albumin BCP | SENTINEL CH. SpA | Dec 19, 2019 | SESE |
| [K132664](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K132664.md) | ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | Oct 16, 2013 | SESE |
| [K021636](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K021636.md) | ALBUMIN REAGENT | Intersect Systems, Inc. | Jul 17, 2002 | SESE |
| [K000483](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K000483.md) | RANDOX ALBUMIN | Randox Laboratories, Ltd. | Mar 31, 2000 | SESE |
| [K990978](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K990978.md) | ALBUMIN BCG, MODEL AL 103-01 | A.P. Total Care, Inc. | May 25, 1999 | SESE |
| [K981814](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K981814.md) | ALBP | Abbott Laboratories | Jul 22, 1998 | SESE |
| [K981457](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K981457.md) | ALBP | Abbott Mfg., Inc. | May 27, 1998 | SESE |
| [K913025](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K913025.md) | ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 | Em Diagnostic Systems, Inc. | Oct 9, 1991 | SESE |
| [K905776](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K905776.md) | ALBUMIN REAGENT SET | Biochemical Trade, Inc. | Feb 26, 1991 | SESE |
| [K863226](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K863226.md) | ALBUMIN (BCP) | Sigma Diagnostics, Inc. | Sep 17, 1986 | SESE |
| [K863004](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K863004.md) | EMDS(TM) ALBUMIN TESTPACKS, #67652/95 | Em Diagnostic Systems, Inc. | Sep 16, 1986 | SESE |
| [K862138](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K862138.md) | VISION ALBUMIN | Abbott Laboratories | Jun 17, 1986 | SESE |
| [K860423](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K860423.md) | A-GENT LIQUID ALBUMIN | Abbott Laboratories | Mar 17, 1986 | SESE |
| [K844426](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K844426.md) | ALBUMIN BCP | Boehringer Mannheim Corp. | Jan 7, 1985 | SESE |
| [K842847](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K842847.md) | WAKO AUTOMATED REAGENTS FOR HITACHI 705 | Wako Chemicals USA, Inc. | Dec 11, 1984 | SESE |
| [K832632](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K832632.md) | ALBUMIN PROCEDURE BCP | Sandare Chemical Co., Inc. | Sep 12, 1983 | SESE |
| [K830934](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CJW/K830934.md) | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN | Quantimetrix Corp. | Apr 18, 1983 | SESE |

## Top Applicants

- Abbott Laboratories — 3 clearances
- Em Diagnostic Systems, Inc. — 2 clearances
- A.P. Total Care, Inc. — 1 clearance
- Abbott Ireland Diagnostics Division — 1 clearance
- Abbott Mfg., Inc. — 1 clearance

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

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