Product Code: CEP FDA class 1 21 CFR 862.1485

Radioimmunoassay, Luteinizing Hormone

Clinical Chemistry

The Luteinizing Hormone Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody techniques to measure luteinizing hormone (LH) levels in serum, used in the assessment of reproductive endocrine function, diagnosis of infertility, and evaluation of pituitary disorders. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CEP, regulated under 21 CFR 862.1485, within the Clinical Chemistry medical specialty. No special flags apply to this device.

View on FDA

510(k)s

143

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code CEP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: CEP
Device Class: FDA class 1
Regulation Number: 862.1485
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

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 143 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K013582	MAYBE?MOM MINI OVULATION MICROSCOPE	Jan 16, 2003	Substantially Equivalent	Maybe?Mom
K022829	INSTANT-VIEW LH OVULATION PREDICTING TEST	Nov 05, 2002	Substantially Equivalent	Alfa Scientific Designs, Inc.
K021409	AT HOME OVULATION TEST, MODEL 9032	May 24, 2002	Substantially Equivalent	Phamatech, Inc.
K013874	CLEARPLANE EASY OVULATION TEST	Feb 19, 2002	Substantially Equivalent	Unipath , Ltd.
K013323	TCI-31 LIFELONG OVULATION TESTER	Dec 05, 2001	Substantially Equivalent	Tci New York
K012252	QUIK-CHECK OVULATION PREDICTOR	Aug 24, 2001	Substantially Equivalent	ACON Laboratories, Inc.
K010244	SURE CHECK OVULATION PREDICTOR	May 02, 2001	Substantially Equivalent	Chembio Diagnostic Systems, Inc.
K002867	INVERNESS MEDICAL OVULATION PREDICTOR TEST	Oct 12, 2000	Substantially Equivalent	Selfcare, Inc.
K991466	EARLY OVULATION PREDICTOR (CASSETTE), ONE STEP OVULATION PREDICTOR (CASSETTE), OVULATION PREDICTOR (CASSETTE)	May 25, 1999	Substantially Equivalent	Selfcare, Inc.
K991386	EARLY OVULATION PREDICTOR (STICK), ONE STEP OVULATION PREDICTOR (STICK), OVULATION PREDICTOR (STICK)	May 25, 1999	Substantially Equivalent	Selfcare, Inc.
K990249	OVUSTICK LH OVULATION PREDICTOR, MODEL 9030, OVUCARD LH OVULATION PREDICTOR, MODEL 9031	Mar 22, 1999	Substantially Equivalent	Phamatech
K983113	BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT	Nov 18, 1998	Substantially Equivalent	Syntron Bioresearch, Inc.
K981271	CLEARPLAN EASY OVULATION TEST	Jun 25, 1998	Substantially Equivalent	Unipath , Ltd.
K974508	DBEST ONE-STEP OVULATION TEST	Feb 02, 1998	Substantially Equivalent	Ameritek, Inc.
K973310	TBD* ONE-STEP OVULATION PREDICTOR TEST	Oct 27, 1997	Substantially Equivalent	Armkel, LLC
K970467	EZ SURE ONE STEP OVULATION PREDICTOR HOME TEST KIT	Mar 18, 1997	Substantially Equivalent	Excel Scientific, Inc.
K964982	VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)	Feb 20, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K964694	ELECSYS LH ASSAY	Jan 24, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K964925	SEALITE SCIENCES, INC. AQUALITE LH	Jan 22, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K963693	OVUSIGN - ONE-STEP HOME OVULATION PREDICTOR TEST	Nov 29, 1996	Substantially Equivalent	Princeton BioMeditech Corp.
K962866	OPUS HLH	Aug 23, 1996	Substantially Equivalent	Behring Diagnostics, Inc.
K962041	ACS LH2 IMMUNOASSAY	Jun 21, 1996	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K960233	MINICLINIC OVULATION PREDICTOR	Apr 23, 1996	Substantially Equivalent	Vanguard Biomedical Corp.
K961109	ACTIVE LH IRMA	Apr 05, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K953581	FIRST RESPONSE OVULATION PREDICTOR TEST	Oct 03, 1995	Substantially Equivalent	Armkel, LLC
K953063	CONCEIVE OVULATION PREDICTOR	Aug 23, 1995	Substantially Equivalent	Quidel Corp.
K951538	BESURE ONE-=STEP HOME OVULATION PREDICTOR KIT	Jul 11, 1995	Substantially Equivalent	Syntron Bioresearch, Inc.
K951748	COAT-A-COUNT LH IRMA	May 15, 1995	Substantially Equivalent	Diagnostic Products Corp.
K935319	CHEMILUMINESCENCE LH	Apr 05, 1995	Substantially Equivalent	Nichols Institute Diagnostics
K943252	PRO-STEP LH OVULATION PREDICTION TEST	Oct 25, 1994	Substantially Equivalent	Disease Detection International, Inc.
K943996	DUPONT ACA PLUS LUTEINIZING HORMONE (LH) METHOD	Oct 20, 1994	Substantially Equivalent	Dupont Medical Products
K943188	SEALITE SCIENCE, INC. AQUALITE(R) LH	Oct 20, 1994	Substantially Equivalent	Sealite Sciences, Inc.
K942638	SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT	Sep 07, 1994	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K940549	ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY	Apr 06, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K935134	ONE STEP LH TEST	Jan 11, 1994	Substantially Equivalent	Tcpi, Inc.
K930306	COBAS CORE LH EIA	May 26, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K926394	VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY	May 26, 1993	Substantially Equivalent	Syva Co.
K930185	OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP	Mar 04, 1993	Substantially Equivalent	Princeton Biomedix
K922944	IMMUCHEM LH-MW ELISA	Feb 02, 1993	Substantially Equivalent	Icn Biomedicals, Inc.
K921176	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM	Apr 08, 1992	Substantially Equivalent	Vitek Systems, Inc.
K920920	ELISA TUBE LH TEST KIT	Apr 08, 1992	Substantially Equivalent	Bio Clinic Co.
K920411	IMMULITE HLH	Mar 11, 1992	Substantially Equivalent	Cirrus Diagnostics, Inc.
K920160	LH GEN III SELF-TEST/CONCEIVE	Mar 11, 1992	Substantially Equivalent	Quidel Corp.
K920504	MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT	Mar 02, 1992	Substantially Equivalent	Medix Biotech, Inc.
K913938	OPUS(R) LH TEST SYSTEM	Nov 07, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K911050	LH IRMA IMMUNOMAG	Apr 12, 1991	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K910351	MINICLINIC OVULATION PREDICTION TEST	Mar 21, 1991	Substantially Equivalent	Vanguard Biomedical Corp.
K910717	PANTEX IRMA LH 1251 KIT	Mar 19, 1991	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K910198	CIBA CORNING ACS LH IMMUNOASSAY	Feb 04, 1991	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904387	BIOCLONES ELEGANCE LH ELISA KIT	Nov 06, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K902786	MILENIA (TM) LH	Oct 12, 1990	Substantially Equivalent	Diagnostic Products Corp.
K903052	IMMUNOCORP LH IRMA COATED TUBE	Aug 29, 1990	Substantially Equivalent	Immunocorp Sciences, Inc.
K902443	LUMATAG(TM) LH DIAGNOSTIC KIT	Aug 02, 1990	Substantially Equivalent	London Diagnostics, Inc.
K902208	MODIFIED OVUGEN	Jul 17, 1990	Substantially Equivalent	Biogenex Laboratories
K902398	CIBA CORNING MAGIC LITE LH IMMUNOASSAY	Jun 28, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K900779	ENZYMUN TEST(R) LH	Apr 03, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K900621	FIAGEN(TM) HLH.S	Mar 01, 1990	Substantially Equivalent	Cyberfluor, Inc.
K896866	LUTEINIZING HORMONE-EIA-XT	Feb 13, 1990	Substantially Equivalent	In Vitro Diagnostics, Inc.
K896642	MODIFIED LH ENZYME IMMUNOASSAY TEST KIT	Jan 30, 1990	Substantially Equivalent	Medix Biotech, Inc.
K895094	TANDEM-E LH IMMUNOENZYMETRIC ASSAY KIT	Oct 31, 1989	Substantially Equivalent	Hybritech, Inc.
K894579	CLEARPLAN EASY	Oct 12, 1989	Substantially Equivalent	Unipath , Ltd.
K894279	LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST	Aug 15, 1989	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K891762	MINICLINIC OVULATION PREDICTION TEST	Jul 20, 1989	Substantially Equivalent	Vanguard Biomedical Corp.
K893605	SRI LUTEINIZING HORMONE IMMUNOENZYMETRIC ASSAY	Jun 20, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K890510	ABBOTT OVULATION PREDICTOR TEST	Mar 24, 1989	Substantially Equivalent	Abbott Laboratories
K883814	DELFIA HLH SPEC KIT	Mar 08, 1989	Substantially Equivalent	Pharmacia, Inc.
K884498	COTUBE LH IRMA ASSAY	Dec 22, 1988	Substantially Equivalent	Bio-Rad
K883530	FIRST RESPONSE 10 MINUTE OVULATION PREDICTOR TEST	Dec 19, 1988	Substantially Equivalent	Tambrands, Inc.
K884138	ABBOTT IMX LH	Nov 29, 1988	Substantially Equivalent	Abbott Laboratories
K882340	LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA	Aug 08, 1988	Substantially Equivalent	Serono Diagnostics, Inc.
K882252	PHASE II LH KIT	Aug 04, 1988	Substantially Equivalent	Vitek Systems, Inc.
K880933	AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST	Jul 28, 1988	Substantially Equivalent	Amersham Corp.
K881124	ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY	Apr 18, 1988	Substantially Equivalent	Nichols Institute Diagnostics
K880758	SUCROSEP SPECIFIC IMMUNORADIOMETRIC ASSAY	Apr 18, 1988	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K874624	FIAGEN(TM) HLH CATALOGUE NUMBER: 102-301	Jan 11, 1988	Substantially Equivalent	Cyberfluor, Inc.
K874032	IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5	Dec 30, 1987	Substantially Equivalent	Diagnostic Products Corp.
K870584	O.P.T.(TM) OVULATION PREDICTION TEST	Nov 25, 1987	Substantially Equivalent	Warner-Lambert Co.
K873534	OVUGEN SURETEST	Nov 23, 1987	Substantially Equivalent	Biogenex Laboratories
K873668	MEDIX BIOTECH LH ENZYME IMMUNOASSAY TEST KIT	Oct 07, 1987	Substantially Equivalent	Medix Biotech, Inc.
K871241	ANSWER OVULATION TEST KIT	Oct 02, 1987	Substantially Equivalent	Armkel, LLC
K873186	LH MAIACLONE IMMUNORADIO. ASSAY KIT, MAG SOLID PHA	Sep 29, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K873052	STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY	Sep 14, 1987	Substantially Equivalent	American Dade
K872131	TANDEMR M-PAK LH IMMUNOENZYMETRIC ASSAY	Aug 25, 1987	Substantially Equivalent	Hybritech, Inc.
K872727	LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT, MAG. PHASE	Aug 05, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K871332	CLEARPLAN	Aug 05, 1987	Substantially Equivalent	Unipath , Ltd.
K871726	OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)	Jul 27, 1987	Substantially Equivalent	Monoclonal Antibodies, Inc.
K871602	MICROCHECK LH OVULATION TEST	Jun 11, 1987	Substantially Equivalent	Syntron Bioresearch, Inc.
K863934	DPC COAT-A-COUNT IRMA LH KIT	Feb 06, 1987	Substantially Equivalent	Diagnostic Products Corp.
K863442	UBI MAGIWEL(TM) LH QUANTITATIVE & QUALITATIVE	Feb 04, 1987	Substantially Equivalent	United Biotech, Inc.
K862055	CANWEST OVU-BLUE	Jan 06, 1987	Substantially Equivalent	Canwest Medictex, Inc.
K864144	LUTEINIZING HORMONE (LH-IRMA) RIA KIT	Nov 24, 1986	Substantially Equivalent	Immuchem Corp.
K863929	TERUMO SENSIBEAD(TM) EIA HLH KIT	Nov 13, 1986	Substantially Equivalent	Terumo Medical Corp.
K863679	ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM	Oct 16, 1986	Substantially Equivalent	Nichols Institute Diagnostics
K861354	RIGHT-DAY OVULATION HOME TEST	Sep 16, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K860828	FORETEL, COLOR OVULATION TEST	Aug 04, 1986	Substantially Equivalent	Nms Pharmaceuticals, Inc.
K860538	RIGHT-DAY URINARY LH (EIA)	Jul 29, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K862180	MODIFIED COTROPIN RADIOIMMUNOASSAY KIT	Jul 07, 1986	Substantially Equivalent	Clinetics Corp.
K860984	TANDEM ICON LH ASSAY (URINE) IMMUNOENZYMETRIC KIT	Apr 29, 1986	Substantially Equivalent	Hybritech, Inc.
K860334	VISI-CHECK HLH TEST MONOCLONAL	Apr 21, 1986	Substantially Equivalent	Bioclinical Systems, Inc.
K860333	MICRO-ELISA HLH TEST KIT MONOCLONAL	Apr 21, 1986	Substantially Equivalent	Bioclinical Systems, Inc.
K860308	SUCROSEP LUTEINIZING HORMONE (LH) IRMA	Mar 17, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K855173	DELFIA TM HLH KIT	Feb 28, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K854838	LEE-BEAD BETA LH (EIA)	Jan 07, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K853142	OVUTIME OVULATION PREDICTOR TEST	Dec 17, 1985	Substantially Equivalent	Advanced Care Products
K853837	LH/FSH RADIOIMMUNOASSAY KIT	Oct 16, 1985	Substantially Equivalent	Bioclinical Group
K852146	QUIDEL QUEST OVULATION TEST	Jul 29, 1985	Substantially Equivalent	Quidel Corp.
K851445	COLOR OVULATION TEST	Jul 29, 1985	Substantially Equivalent	Nms Pharmaceuticals, Inc.
K852376	SIMULTANEOUS LH/FSH SYSTEM BY RIA	Jul 09, 1985	Substantially Equivalent	American Bioclinical, Inc.
K851332	BLHI LUTEINIZING HORMONE	Jul 09, 1985	Substantially Equivalent	Euro-Diagnostics BV
K851104	AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT	Apr 10, 1985	Substantially Equivalent	Amersham Corp.
K850480	OVU STICK SELF-TEST -MODIFICATION	Mar 05, 1985	Substantially Equivalent	Monoclonal Antibodies, Inc.
K843284	OVUSTICK SELF-TEST	Dec 11, 1984	Substantially Equivalent	Monoclonal Antibodies, Inc.
K841545	ENZYME IMMUNOASSAY FOR DETECTION HORM	Nov 27, 1984	Substantially Equivalent	Btc Diagnostics, Inc.
K842445	LH RIA	Sep 04, 1984	Substantially Equivalent	Syncor Intl. Corp.
K840412	OVU STICK URINE HLH KIT	Apr 13, 1984	Substantially Equivalent	Monoclonal Antibodies, Inc.
K840188	MICROMEDIC LH & FSH RIA KIT	Mar 23, 1984	Substantially Equivalent	Micromedic Systems
K840174	LH QUIK RIA KIT	Mar 19, 1984	Substantially Equivalent	Pacific Biotech, Inc.
K833854	LH RIA	Jan 13, 1984	Substantially Equivalent	Syncor Intl. Corp.
K833376	RIANEN LUTEINIZING HORMONE RIA KIT	Dec 20, 1983	Substantially Equivalent	New England Nuclear
K823476	GAMMADAB LH RADIO-KIT #CA-1508	Dec 28, 1982	Substantially Equivalent	Clinical Assays, Inc.
K823380	125-I LH RADIOIMMUNOASSAY KIT	Dec 22, 1982	Substantially Equivalent	Clinetics Corp.
K822288	LH (125I) RADIOIMMUNOASSAY	Sep 13, 1982	Substantially Equivalent	Corning Medical & Scientific
K821346	QUANTIMUNE HLH RIA	May 28, 1982	Substantially Equivalent	Bio-Rad
K820760	LH RADIOIMMUNOASSAY TEST SYSTEM	Apr 16, 1982	Substantially Equivalent	Monobind
K820741	MR1 LUTROPIN RIA KIT	Apr 14, 1982	Substantially Equivalent	Microanalytic Research, Inc.
K820753	AMERLEX LH RIA KIT (CODE IM2081)	Apr 09, 1982	Substantially Equivalent	Amersham Corp.
K820357	LUTEINIZING HORMONE KIT	Mar 25, 1982	Substantially Equivalent	Pcl-Ria, Inc.
K813213	SHARIA-LH RIA KIT FOR QUANTITATION HORMO	Dec 22, 1981	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K811994	RADIOIMMUNOASSAY LUTEINIZING HORMONE	Jul 27, 1981	Substantially Equivalent	Endocrine-Metabolic Center
K811024	LUTEINIZING HORMONE DIRECT RIA KIT 125/I	May 08, 1981	Substantially Equivalent	Immunalysis Corporation
K810754	LUTENIZING HORMONES	Mar 31, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K810741	LUTEINIZING HORMONE	Mar 31, 1981	Substantially Equivalent	Pcl-Ria, Inc.
K810662	LEECO LH-QUANT DIAGNOSTIC KIT	Mar 31, 1981	Substantially Equivalent	Leeco Diagnostics, Inc.
K810302	QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM	Feb 25, 1981	Substantially Equivalent	Bio-Rad
K803278	LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT	Jan 21, 1981	Substantially Equivalent	Immuno Nuclear Corp.
K800106	LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS	Feb 13, 1980	Substantially Equivalent	Radioimmunoassay, Inc.
K792350	CENTRIA LH RIA	Jan 16, 1980	Substantially Equivalent	Union Carbide Corp.
K792000	LUTEINIZING HORMONE (LH) RIA	Oct 30, 1979	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.
K791405	125I LEUTINIZING HORMONE RIA KIT	Sep 17, 1979	Substantially Equivalent	Diagnostic Products Corp.
K781685	RIA KIT, LH	Oct 27, 1978	Substantially Equivalent	Amersham Corp.
K780576	125-I LABELED HUMAN LUTEINIZING HORMONE	May 19, 1978	Substantially Equivalent	Pcl-Ria, Inc.
K780367	RIA SYS. FOR HUMAN LUTEINIZING HORMONE	Apr 28, 1978	Substantially Equivalent	Calbiochem-Behring Corp.
K770854	LUTEINIZING HORMONE RIA REAGENT, LH-RIA	May 26, 1977	Substantially Equivalent	Nichols Institute Diagnostics