Product Code: CJW FDA class 2 21 CFR 862.1035

Bromcresol Purple Dye-Binding, Albumin

Clinical Chemistry

The Bromcresol Purple Dye-Binding, Albumin test system (product code CJW) is an in-vitro diagnostic device used in clinical chemistry to measure albumin concentrations in serum using the bromcresol purple (BCP) dye-binding colorimetric method. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1035 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CJW
Device Class: FDA class 2
Regulation Number: 862.1035
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 18 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K203530	Albumin BCP2	Mar 18, 2022	Substantially Equivalent	Abbott Ireland Diagnostics Division
K193001	Albumin BCP	Dec 19, 2019	Substantially Equivalent	SENTINEL CH. SpA
K132664	ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR	Oct 16, 2013	Substantially Equivalent	Siemens Healthcare Diagnostics, Inc.
K021636	ALBUMIN REAGENT	Jul 17, 2002	Substantially Equivalent	Intersect Systems, Inc.
K000483	RANDOX ALBUMIN	Mar 31, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K990978	ALBUMIN BCG, MODEL AL 103-01	May 25, 1999	Substantially Equivalent	A.P. Total Care, Inc.
K981814	ALBP	Jul 22, 1998	Substantially Equivalent	Abbott Laboratories
K981457	ALBP	May 27, 1998	Substantially Equivalent	Abbott Mfg., Inc.
K913025	ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16	Oct 09, 1991	Substantially Equivalent	Em Diagnostic Systems, Inc.
K905776	ALBUMIN REAGENT SET	Feb 26, 1991	Substantially Equivalent	Biochemical Trade, Inc.
K863226	ALBUMIN (BCP)	Sep 17, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K863004	EMDS(TM) ALBUMIN TESTPACKS, #67652/95	Sep 16, 1986	Substantially Equivalent	Em Diagnostic Systems, Inc.
K862138	VISION ALBUMIN	Jun 17, 1986	Substantially Equivalent	Abbott Laboratories
K860423	A-GENT LIQUID ALBUMIN	Mar 17, 1986	Substantially Equivalent	Abbott Laboratories
K844426	ALBUMIN BCP	Jan 07, 1985	Substantially Equivalent	Boehringer Mannheim Corp.
K842847	WAKO AUTOMATED REAGENTS FOR HITACHI 705	Dec 11, 1984	Substantially Equivalent	Wako Chemicals USA, Inc.
K832632	ALBUMIN PROCEDURE BCP	Sep 12, 1983	Substantially Equivalent	Sandare Chemical Co., Inc.
K830934	QUANTIMETRIX BROMERESOL PURPLE ALBUMIN	Apr 18, 1983	Substantially Equivalent	Quantimetrix Corp.