Product Code: DEH FDA class 2 21 CFR 866.5550

Lambda, Antigen, Antiserum, Control

Immunology

This is an immunological reagent kit for detecting the lambda light chain of immunoglobulins, one of two types of light chains present in antibody molecules, including antigen, antiserum, and control components for clinical immunoassay testing. Lambda light chain measurement is used in the evaluation of multiple myeloma, Waldenstrom's macroglobulinemia, and other plasma cell dyscrasias. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is eligible for third-party review. The product code is DEH, regulated under 21 CFR 866.5550, within the Immunology specialty.

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Basic Information

Product Code: DEH
Device Class: FDA class 2
Regulation Number: 866.5550
Medical Specialty: Immunology
Review Panel: IM
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 53 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172471	VENTANA CD30 (Ber-H2) RxDx Assay	May 08, 2018	Substantially Equivalent	Ventana Medical Systems, Inc.
K140396	FREELITE HUMAN LAMBDA FREE KIT	Apr 16, 2014	Substantially Equivalent	The Binding Site Group , Ltd.
K083601	LAMBDA LIGHT CHAINS	Jun 22, 2009	Substantially Equivalent	SENTINEL CH. SpA
K033811	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER	Jan 30, 2004	Substantially Equivalent	The Binding Site, Ltd.
K031016	FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II	Jul 15, 2003	Substantially Equivalent	The Binding Site, Ltd.
K023131	FREELITE HUMAN LAMBDA FREE KIT	Jan 21, 2003	Substantially Equivalent	The Binding Site, Ltd.
K010441	FREELITE KAPPA FREE KIT	Apr 26, 2001	Substantially Equivalent	The Binding Site, Ltd.
K010440	FREELITE LAMBDA FREE KIT	Apr 26, 2001	Substantially Equivalent	The Binding Site, Ltd.
K003671	LAMBDA IMMAGE FREELITE KIT	Feb 01, 2001	Substantially Equivalent	The Binding Site, Ltd.
K002563	SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT	Oct 26, 2000	Substantially Equivalent	The Binding Site, Ltd.
K971905	DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING	Dec 12, 1997	Substantially Equivalent	Dako Corp.
K965022	MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751)	Nov 06, 1997	Substantially Equivalent	Dako Corp.
K940583	VENTANA CD45 PRIMARY ANTIBODY	Oct 20, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K973393	CHEMMATE LCA	Sep 25, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941514	VENTANA ANTI-S100 PRIMARY ANTIBODY	Apr 25, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941170	VENTANA ANTI-MELANOMA PRIMARY ANTIBODY	Apr 22, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941707	ANTI-MUSCLE ACTIN PRIMARY ANTIBODY	Apr 21, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941784	VENTANA ANTI-CD8 PRIMARY ANTIBODY	Feb 14, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941604	VENTANA ANTI-CD4 PRIMARY ANTIBODY	Feb 14, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941516	VENTANNA ANTI-DESMIN PRIMARY ANTIBODY	Feb 10, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941397	ANTI-VIMENTIN PRIMARY ANTIBODY	Feb 10, 1997	Substantially Equivalent	Ventana Medical Systems, Inc.
K941782	VENTANA ANTI-CD5 PRIMARY ANTIBODY	Sep 10, 1996	Substantially Equivalent	Ventana Medical Systems, Inc.
K951965	DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION	Jul 05, 1996	Substantially Equivalent	Dako Corp.
K950148	CHEMMATE(TM) CD43	Jul 02, 1996	Substantially Equivalent	Biotek Solutions, Inc.
K941505	VENTANNA ANTI-CD3 PRIMARY ANTIBODY	May 30, 1996	Substantially Equivalent	Ventana Medical Systems, Inc.
K941173	ANTI-KERATIN-HMW PRIMARY ANTI-BODY	Mar 22, 1996	Substantially Equivalent	Ventana Medical Systems, Inc.
K935161	KERATIN PRIMARY ANTIBODY	Mar 22, 1996	Substantially Equivalent	Ventana Medical Systems, Inc.
K936111	CHEMMATE SPECIAL STAIN LCA-CD45	Feb 27, 1996	Substantially Equivalent	Biotek Solutions, Inc.
K940331	KERATIN PRIMARY ANTIBODY	Feb 26, 1996	Substantially Equivalent	Ventana Medical Systems, Inc.
K950149	CHEMMATE(TM) LAMBDA	Dec 06, 1995	Substantially Equivalent	Biotek Solutions, Inc.
K940424	VENTANA BLUE DETECTION KIT	Nov 06, 1995	Substantially Equivalent	Ventana Medical Systems, Inc.
K950151	CHEMMATE(TM) L26 (CD20)	Oct 04, 1995	Substantially Equivalent	Biotek Solutions, Inc.
K931192	DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY	Apr 20, 1995	Substantially Equivalent	Dako Corp.
K924804	DAKO MOUSE ANTI-HUMAN T-CELL	Nov 21, 1994	Substantially Equivalent	Dako Corp.
K932136	DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)	Jun 13, 1994	Substantially Equivalent	Dako Corp.
K924726	DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI	Jun 13, 1994	Substantially Equivalent	Dako Corp.
K932326	PSA ANTIBODY KIT	Aug 06, 1993	Substantially Equivalent	Ventana Medical Systems, Inc.
K896918	MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT	Aug 27, 1990	Substantially Equivalent	Dako Corp.
K902485	BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS)	Jun 21, 1990	Substantially Equivalent	Beckman Instruments, Inc.
K875165	QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK	Jan 22, 1988	Substantially Equivalent	Kallestad Diag, A Div. of Erbamont, Inc.
K855013	QUANTIMETRIC PLUS SUPPORT PACK	Feb 26, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K855007	QUANTIMETRIC PLUS LAMBDA REAGENT KIT	Feb 26, 1986	Substantially Equivalent	Kallestad Laboratories, Inc.
K852999	QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT	Oct 21, 1985	Substantially Equivalent	Kallestad Laboratories, Inc.
K842328	AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN	Aug 03, 1984	Substantially Equivalent	Bartels Immunodiagnostic Supplies, Inc.
K841864	QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT	Jul 11, 1984	Substantially Equivalent	Kallestad Laboratories, Inc.
K832270	GOAT ANTI-HUMAN LAMBA	Oct 31, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K832261	GOAT ANTI-HUMAN LAMBA AFFINITY	Oct 28, 1983	Substantially Equivalent	Gelco Diagnostics, Inc.
K812662	IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA	Sep 29, 1981	Substantially Equivalent	Dako Corp.
K791283	ANTI-HUMAN LAMBDA SERUM	Nov 27, 1979	Substantially Equivalent	Diagnostica, Inc.
K791115	GOAR ANTI-HUMAN LAMBODA CHAIN	Aug 03, 1979	Substantially Equivalent	Protos Laboratories
K781220	ANTI-HUMAN LAMBDA SERUM	Jul 27, 1978	Substantially Equivalent	Icl Scientific
K781025	LAMBDA SERUM (FREE) ANTI-HUMAN	Jul 27, 1978	Substantially Equivalent	Icl Scientific
K771768	GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM	Oct 07, 1977	Substantially Equivalent	G.D. Searle and Co.