Product Code: DDB FDA class 2 21 CFR 866.5210

Ceruloplasmin, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting and measuring ceruloplasmin, a multifunctional plasma protein with ferroxidase activity involved in copper transport and iron metabolism, using antigen, antiserum, and control components for standard immunoassay procedures. Ceruloplasmin levels are measured in the evaluation of Wilson's disease and Menkes syndrome. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is DDB, regulated under 21 CFR 866.5210, within the Immunology specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: DDB
Device Class: FDA class 2
Regulation Number: 866.5210
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 4

Device Characteristics

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GMP Exempt

✗

Implant

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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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K161508	Ceruloplasmin	Jan 09, 2017	Substantially Equivalent	Beckman Coulter Ireland, Inc.
K122965	HUMAN CAERULOPLASMIN KIT	Jun 03, 2013	Substantially Equivalent	The Binding Site Group , Ltd.
K053074	N ANTISERA TO HUMAN CERULOPLASMIN	Mar 16, 2006	Substantially Equivalent	Dade Behring, Inc.
K964762	IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT	Apr 25, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K913668	CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT	Dec 20, 1991	Substantially Equivalent	The Binding Site, Ltd.
K895377	QM300 CERULOPLASMIN ANTIBODY PACK	Sep 21, 1989	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K860138	NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM	Mar 28, 1986	Substantially Equivalent	Sigma Diagnostics, Inc.
K850682	72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL	Nov 25, 1985	Substantially Equivalent	Kent Laboratories, Inc.
K852247	LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)	Jul 10, 1985	Substantially Equivalent	Behring Diagnostics, Inc.
K851283	RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN	May 23, 1985	Substantially Equivalent	Cooper Biomedical, Inc.
K823107	QUANTIMETRIC 2 CERULOPLASMIN ASSAY	Nov 16, 1982	Substantially Equivalent	Kallestad Laboratories, Inc.
K812486	IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL	Sep 23, 1981	Substantially Equivalent	Dako Corp.
K801661	J.T. BAKER CERULOPLASMIN NEPHELOMETRIC	Sep 16, 1980	Substantially Equivalent	J.T. Baker Chemical Co.
K791339	HUMAN CERULOPLASMIN	Aug 16, 1979	Substantially Equivalent	Beckman Instruments, Inc.
K790714	ANTISERUM TO HUMAN CERULOPLASMIN	Aug 16, 1979	Substantially Equivalent	Kent Laboratories, Inc.
K790712	ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI	Aug 16, 1979	Substantially Equivalent	Kent Laboratories, Inc.
K781024	CERUOPLASMIN SERUM ANTI-HUMAN	Aug 14, 1978	Substantially Equivalent	Icl Scientific
K772255	CERULOPLASMIN NEPHEL. ASSAY	Jan 05, 1978	Substantially Equivalent	Kallestad Laboratories, Inc.
K771795	LAS-R CERULOPLASMIN TEST	Nov 14, 1977	Substantially Equivalent	Hyland Therapeutic Div., Travenol Laboratories