Product Code: CEF FDA class 1 21 CFR 862.1630

Electrophoretic, Protein Fractionation

Clinical Chemistry

The Electrophoretic Protein Fractionation Test is a clinical chemistry device that uses electrophoresis to separate serum proteins into distinct fractions (albumin, alpha-1, alpha-2, beta, and gamma globulins) based on their charge and size, used in the diagnosis of monoclonal gammopathies, liver disease, and inflammatory conditions. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEF, regulated under 21 CFR 862.1630, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: CEF
Device Class: FDA class 1
Regulation Number: 862.1630
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

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 29 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130500	CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2 FLEX PIERCING INSTRUMENT	Jul 26, 2013	Substantially Equivalent	Sebia
K972274	SPIFE	Oct 27, 1997	Substantially Equivalent	Helena Laboratories
K973316	REP SPE VIS-60/40 KIT	Oct 01, 1997	Substantially Equivalent	Helena Laboratories
K963018	BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS	Jun 04, 1997	Substantially Equivalent	Bio-Rad
K964453	REP 3 FLUR SPE-60 KIT	Dec 23, 1996	Substantially Equivalent	Helena Laboratories
K960029	HYDRASYS AGAROSE GEL ELECTROPHORESIS APPARATUS/HYDRAGEL 15,30 PROTEIN KIT	Jul 17, 1996	Substantially Equivalent	Morax
K951536	HYDRAGEL PROTEIN(E) KIT	Jun 30, 1995	Substantially Equivalent	Sebia
K930317	REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278	Aug 03, 1993	Substantially Equivalent	Helena Laboratories
K922053	REP SPE PLUS (PONCEAU S) SYSTEM	Aug 18, 1992	Substantially Equivalent	Helena Laboratories
K922024	REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175	Jul 23, 1992	Substantially Equivalent	Helena Laboratories
K913315	BIO-RAD TOTAL PROTEIN TEST KIT	Jan 02, 1992	Substantially Equivalent	Bio-Rad
K913807	REP(R) SPE TEMPLATE 30, 16, & 8	Nov 27, 1991	Substantially Equivalent	Helena Laboratories
K913058	REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172	Oct 30, 1991	Substantially Equivalent	Helena Laboratories
K912386	REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165	Jul 17, 1991	Substantially Equivalent	Helena Laboratories
K911468	REP SPE PLUS (ACID BLUE) SYSTEM	Apr 16, 1991	Substantially Equivalent	Helena Laboratories
K900251	REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175	Feb 26, 1990	Substantially Equivalent	Helena Laboratories
K894585	REP TM SPE (PONCEAU S) PROCEDURES	Sep 13, 1989	Substantially Equivalent	Helena Laboratories
K893211	REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171	Jun 19, 1989	Substantially Equivalent	Helena Laboratories
K870958	TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091	Apr 29, 1987	Substantially Equivalent	Helena Laboratories
K843397	CORNING HIGH RESOLUTION PROTEIN ELECTRO	Sep 14, 1984	Substantially Equivalent	Corning Medical & Scientific
K833855	TITAN GEL SILVER STAIN SYSTEM	Feb 27, 1984	Substantially Equivalent	Helena Laboratories
K811725	TBG DIAGNOSTIC KIT	Jul 10, 1981	Substantially Equivalent	Immuno Assay Corp.
K802592	PARAGON SERUM PROTEIN ELECTROPHORESIS	Nov 12, 1980	Substantially Equivalent	Beckman Instruments, Inc.
K781123	PONCEAU S	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K781120	TRICHLORACETIC ACID 7.5%	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K781118	ECA BUFFER PH 8.8	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K781117	ECA PREP	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K781116	ECA BUFFER, PH 816	Aug 10, 1978	Substantially Equivalent	Electrophoresis Corp. of America
K771720	AMIDO BLACK CONCENTRATE	Nov 03, 1977	Substantially Equivalent	Sigma Chemical Co.