Product Code: CFF FDA class 2 21 CFR 866.5510

Immunoelectrophoretic, Immunoglobulins, (G, A, M)

Immunology

The Immunoelectrophoretic Immunoglobulins (G, A, M) Test is an immunology device that combines electrophoresis with immunoprecipitation to identify and characterize immunoglobulin classes IgG, IgA, and IgM in serum or urine, used in the diagnosis of multiple myeloma, Waldenstrom macroglobulinemia, and other immunoproliferative disorders. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CFF, regulated under 21 CFR 866.5510, within the Immunology medical specialty. This device is eligible for third-party review.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: CFF
Device Class: FDA class 2
Regulation Number: 866.5510
Medical Specialty: Immunology
Review Panel: IM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

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
K203184	HYDRASHIFT 2/4 isatuximab	Nov 12, 2021	Substantially Equivalent	Sebia
K192095	CAPI 3 Immunotyping, Capillarys 3 Tera	Nov 01, 2019	Substantially Equivalent	Sebia
K190851	HYDRASHIFT 2/4 daratumumab	May 02, 2019	Substantially Equivalent	Sebia
K172195	HYDRASHIFT 2/4 daratumumab, daratumumab Control	Jan 11, 2018	Substantially Equivalent	Sebia
K161928	CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL	Dec 21, 2016	Substantially Equivalent	Sebia
K143483	MINICAP Immunotyping using the MINICAP and the MINICAP FLEX-PIERCING	Jan 08, 2015	Substantially Equivalent	Sebia
K120169	INTERLAB IFE TEST USING G 26 VER. 2.0 INSTRUMENT	Aug 24, 2012	Substantially Equivalent	Grifols USA, LLC
K111369	THE HELENA V8 IMMUNODISPLACEMENT KIT	Jun 26, 2012	Substantially Equivalent	Helena Laboratories Uk, Ltd.
K103757	IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT	Oct 13, 2011	Substantially Equivalent	Grifols
K082085	CAPILLARYS IMMUNOTYPING, MODEL 2100	Apr 17, 2009	Substantially Equivalent	Sebia
K082388	MINICAP IMMUNOTYPING, MODEL: 2300	Apr 14, 2009	Substantially Equivalent	Sebia
K061069	SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458	Jul 06, 2006	Substantially Equivalent	Helena Laboratories
K033187	INTERLAB IMMUNOFIXATION TEST(S)	Nov 19, 2003	Substantially Equivalent	Interlab S.R.L.
K033277	HYDRAGEL CSF ISOFOCUSING KITS	Nov 04, 2003	Substantially Equivalent	Morax
K024162	SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389	Feb 19, 2003	Substantially Equivalent	Helena Laboratories
K002799	PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100	Oct 05, 2000	Substantially Equivalent	Beckman Coulter, Inc.
K993323	K-ASSAY IGM	Nov 30, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K993213	K-ASSAY IGA	Nov 23, 1999	Substantially Equivalent	Kamiya Biomedical Co.
K990998	POLYSLIT IFE KIT	Jun 28, 1999	Substantially Equivalent	Helena Laboratories
K981048	HYDRAGEL 6 CSF KIT	Oct 07, 1998	Substantially Equivalent	Morax
K973040	SPIFE IFE-6	Jan 02, 1998	Substantially Equivalent	Helena Laboratories
K960669	HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS	Jul 12, 1996	Substantially Equivalent	Morax
K933972	N-ASSAY TIA IGG	Mar 22, 1994	Substantially Equivalent	Crestat Diagnostics, Inc.
K924769	IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC	Feb 23, 1993	Substantially Equivalent	The Binding Site, Ltd.
K924767	IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC	Feb 23, 1993	Substantially Equivalent	The Binding Site, Ltd.
K923658	REP IMMUNOFIX	Nov 02, 1992	Substantially Equivalent	Helena Laboratories
K892424	REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178	Jun 09, 1989	Substantially Equivalent	Helena Laboratories
K823884	PARAGON IMMUNOELECTROPHORESIS REAGENT	Mar 07, 1983	Substantially Equivalent	Beckman Instruments, Inc.
K790667	CORNING PARAPROTEIN SCREENING	Jul 24, 1979	Substantially Equivalent	Corning Medical & Scientific