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: CGJ FDA class 1

Radioimmunoassay, Follicle-Stimulating Hormone

Clinical Chemistry

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The Radioimmunoassay, Follicle-Stimulating Hormone test system (product code CGJ) is an in-vitro diagnostic device used in clinical chemistry to quantify follicle-stimulating hormone (FSH) in serum or urine using a radioimmunoassay method, supporting the evaluation of reproductive and endocrine disorders. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1300 in the Clinical Chemistry medical specialty.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K052662

ONE STEP FSH MENOPAUSAL TEST

Nov 30, 2005

Substantially Equivalent

IND DIAGNOSTIC INC.

K043599

MOMENTS MENOPAUSE CHECK, MODEL 9113

Feb 25, 2005

Substantially Equivalent

PHAMATECH INC.

K041165

FSH MENOPAUSE PREDICTOR TEST

Jun 17, 2004

Substantially Equivalent

ACON LABORATORIES, INC.

K040575

PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112

May 20, 2004

Substantially Equivalent

PHAMATECH INC.

K030058

EARLYDETECT MENOPAUSE TEST FOR FSH

Jul 30, 2003

Substantially Equivalent

EARLY DETECT, INC.

K002450

GENUA MENOPAUSE MONITOR TEST KIT

Jan 12, 2001

Substantially Equivalent

GENUA 1944, INC.

K972720

FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300)

Sep 02, 1997

Substantially Equivalent

MONOBIND

K970085

SEALITE SCIENCES AQUALITE FSH

Feb 14, 1997

Substantially Equivalent

SEALITE SCIENCES, INC.

K964720

VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005)

Feb 04, 1997

Substantially Equivalent

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

K964693

ELECSYS FSH ASSAY

Dec 16, 1996

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K962118

DSL ACTIVE FSH IRMA

Sep 09, 1996

Substantially Equivalent

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

K952285

AMERLITE FSH ASSAY

Jul 03, 1995

Substantially Equivalent

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

K943437

AQUALITE FSH

Dec 28, 1994

Substantially Equivalent

SEALITE SCIENCES, INC.

K941221

DUPONT ACA PLUS IMMUNOASSAY SYSTEM FOLLICLE STIMULATING HORMONE

Jul 20, 1994

Substantially Equivalent

DUPONT MEDICAL PRODUCTS

K935612

AXSYM FOLLICLE STIMULATING HORMONE (FSH)

Jun 21, 1994

Substantially Equivalent

ABBOTT LABORATORIES

K940005

ACCESS HUMAN FOLLICLE STIMULATING HORMONE ASSAY

Mar 03, 1994

Substantially Equivalent

BIO-RAD LABORATORIES, INC.

K930304

COBAS CORE FSH EIA

Sep 21, 1993

Substantially Equivalent

ROCHE DIAGNOSTIC SYSTEMS, INC.

K922376

ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KIT

Oct 05, 1992

Substantially Equivalent

ICN BIOMEDICALS, INC.

K921746

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM

Jun 16, 1992

Substantially Equivalent

BIOMERIEUX VITEK, INC.

K921704

IMMULITE(R) FSH

Jun 09, 1992

Substantially Equivalent

CIRRUS DIAGNOSTICS, INC.

K920917

ELISA TUBE FSH TEST KIT ENZYME LINKED IMMUN. ASSAY

Mar 26, 1992

Substantially Equivalent

BIO CLINIC CO.

K915208

FSH ENZYME IMMUNASSAY TEST KIT NO:KIF4057

Dec 18, 1991

Substantially Equivalent

MEDIX BIOTECH, INC.

K912804

FSH IRMA IMMUNOMAG

Aug 12, 1991

Substantially Equivalent

PANTEX, DIV. BIO-ANALYSIS, INC.

K911409

OPUS FSH

Apr 16, 1991

Substantially Equivalent

PB DIAGNOSTIC SYSTEMS, INC.

K905814

LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY

Feb 04, 1991

Substantially Equivalent

LONDON DIAGNOSTICS, INC.

K905592

AFFINITY FSH TEST SYSTEM

Dec 27, 1990

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K904649

CIBA CORNING ACS FSH IMMUNOASSAY

Nov 20, 1990

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K904405

BIOCLONES ELEGANCE FSH ELISA KIT

Oct 26, 1990

Substantially Equivalent

BIOCLONE AUSTRALIA PTY LTD.

K901345

MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT NO.MB1050

May 10, 1990

Substantially Equivalent

MEDIX BIOTECH, INC.

K900763

ENZYMUN TEST(R) FSH

Mar 15, 1990

Substantially Equivalent

BOEHRINGER MANNHEIM CORP.

K896864

FOLLICLE STIMULATING HORMONE-EIA-XT

Jan 11, 1990

Substantially Equivalent

IN VITRO DIAGNOSTICS, INC.

K896640

MODIFIED FSH ENZYME IMMUNOASSAY TEST KIT

Jan 02, 1990

Substantially Equivalent

MEDIX BIOTECH, INC.

K895005

MILENIA(TM) FSH (MKFS1,5)

Oct 31, 1989

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K895108

FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM.

Oct 23, 1989

Substantially Equivalent

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

K894761

TANDEM-E FSH IMMUNOENZYMETRIC ASSAY KIT

Sep 13, 1989

Substantially Equivalent

HYBRITECH, INC.

K893976

COAT-A-COUNT (TM) FSH IRMA

Aug 17, 1989

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K892706

SR1 (FSH) IMMUNOENZYMETRIC ASSAY

Jun 09, 1989

Substantially Equivalent

SERONO-BAKER DIAGNOSTICS, INC.

K890135

IMX FOLLICLE STIMULATING HORMONE (FSH)

Feb 10, 1989

Substantially Equivalent

ABBOTT LABORATORIES

K884708

FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT

Jan 17, 1989

Substantially Equivalent

CYBERFLUOR, INC.

K884687

CIBA CORNING MAGIC LITE FSH IMMUNOASSAY

Dec 06, 1988

Substantially Equivalent

CIBA CORNING DIAGNOSTICS CORP.

K883745

IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES

Nov 30, 1988

Substantially Equivalent

DIAGNOSTIC PRODUCTS CORP.

K883305

BINAX FSH IRMA TEST KIT, IMMUNORADIOMETRIC ASSAY

Oct 06, 1988

Substantially Equivalent

BINAX, INC.

K883279

PHASE II FSH KIT

Sep 09, 1988

Substantially Equivalent

VITEK SYSTEMS, INC.

K881142

AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST

Jul 21, 1988

Substantially Equivalent

AMERSHAM CORP.

K881596

FSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1057

May 27, 1988

Substantially Equivalent

MEDIX BIOTECH, INC.

K881123

ALLEGRO(TM) FOLLICLE STIMULATING HORMONE IMMUNO.

Apr 28, 1988

Substantially Equivalent

NICHOLS INSTITUTE DIAGNOSTICS

K873051

STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY

Oct 20, 1987

Substantially Equivalent

AMERICAN DADE

K872309

MICROMEDIC COMBOSTAT LH/FSH KIT

Jul 31, 1987

Substantially Equivalent

MICROMEDIC SYSTEMS

K872627

FSH SEROZYME IMMUNOENZYMETRIC ASSAY KIT/MAG SEP PH

Jul 21, 1987

Substantially Equivalent

SERONO DIAGNOSTICS, INC.

K871317

FOLLICLE STIMULATING HORMONE (HFSH)

May 20, 1987

Substantially Equivalent

IMMUCHEM CORP.

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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