Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: DEH FDA class 2

Lambda, Antigen, Antiserum, Control

Immunology

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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.

510(k) Clearances

50+ matches

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.

K010440

FREELITE LAMBDA FREE KIT

Apr 26, 2001

Substantially Equivalent

THE BINDING SITE, LTD.

K010441

FREELITE KAPPA 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.

K924726

DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI

Jun 13, 1994

Substantially Equivalent

DAKO CORP.

K932136

DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45)

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.

K855007

QUANTIMETRIC PLUS LAMBDA REAGENT KIT

Feb 26, 1986

Substantially Equivalent

KALLESTAD LABORATORIES, INC.

K855013

QUANTIMETRIC PLUS SUPPORT PACK

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

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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