Product Code: JZJ FDA class 1 21 CFR 866.5060

Prealbumin, Antigen, Antiserum, Control

Immunology

Prealbumin, Antigen, Antiserum, Control is an immunological reagent set used to measure prealbumin (transthyretin) concentrations in serum, serving as a sensitive indicator of nutritional status and hepatic protein synthesis, and used in the evaluation of malnutrition and hepatic disease. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZJ, regulated under 21 CFR 866.5060, and falls within the Immunology medical specialty.

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Basic Information

Product Code: JZJ
Device Class: FDA class 1
Regulation Number: 866.5060
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 11 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K000661	RANDOX PREALBUMIN	Apr 13, 2000	Substantially Equivalent	Randox Laboratories, Ltd.
K972638	TINA-QUANT PREALBUMIN	Jan 09, 1998	Substantially Equivalent	Boehringer Mannheim Corp.
K951966	HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT	Jun 01, 1995	Substantially Equivalent	Kent Laboratories, Inc.
K913672	PREALBUMIN IMMUNOLOGICAL NL TEST KIT	Dec 20, 1991	Substantially Equivalent	The Binding Site, Ltd.
K884298	SPQ(TM) TEST SYSTEM FOR MICROALBUMIN	Nov 02, 1988	Substantially Equivalent	Atlantic Antibodies
K884297	SPQ(TM) TEST SYSTEM FOR PREALBUMIN	Nov 02, 1988	Substantially Equivalent	Atlantic Antibodies
K883002	QM300 PREALBUMIN ANTIBODY PACK	Sep 22, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K850686	ANTISERUM TO HUMAN PREALBUMIN	Nov 01, 1985	Substantially Equivalent	Kent Laboratories, Inc.
K851912	LASER PREALBUMIN TEST	Jun 21, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K821135	PREALBUMIN ENZYME IMMUNOASSAY	May 05, 1983	Substantially Equivalent	Abbott Laboratories
K772329	LAS-R HUMAN PREALBUMIN TEST	Feb 03, 1978	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories