Product Code: JHJ FDA class 2 21 CFR 862.1155

Agglutination Method, Human Chorionic Gonadotropin

Clinical Chemistry

Agglutination Method for Human Chorionic Gonadotropin is a clinical chemistry test system that detects HCG in urine or serum through agglutination inhibition reactions, used in the diagnosis of pregnancy and monitoring of conditions such as gestational trophoblastic disease. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification and adherence to general and special controls. The product code is JHJ, regulated under 21 CFR 862.1155, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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FEI Numbers

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Basic Information

Product Code: JHJ
Device Class: FDA class 2
Regulation Number: 862.1155
Medical Specialty: Clinical Chemistry
Review Panel: CH
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 96 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972606	PREGNACOL PREGNANCY TEST	Aug 29, 1997	Substantially Equivalent	Immunostics Inc.,
K921968	IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST	Jun 28, 1996	Substantially Equivalent	Tech-Co, Inc.
K935863	SAS(TM) DIRECT MONOCLONAL HCG	Feb 24, 1994	Substantially Equivalent	Sa Scientific, Inc.
K926112	ACCUTEX BETA-HCG TEST	Jul 28, 1993	Substantially Equivalent	J.S. Medical Assoc.
K930609	SAS(TM) MONOCLONAL HCG-SLIDE	Mar 29, 1993	Substantially Equivalent	Sa Scientific, Inc.
K920716	DIRECT PREGNANCY TEST	Mar 24, 1992	Substantially Equivalent	Tech-Co, Inc.
K910946	CLEARVIEW HCG	Apr 01, 1991	Substantially Equivalent	Unipath , Ltd.
K881435	PREGNOSPIA II	May 27, 1988	Substantially Equivalent	Organon Teknika Corp.
K880163	PREGNANCY (HCG) CARD & LIQUID TEST	May 17, 1988	Substantially Equivalent	Ampcor, Inc.
K880478	PREGNANCY BETA-HCG CARD & LIQUID TEST	Apr 28, 1988	Substantially Equivalent	Ampcor, Inc.
K880328	HCG-NOSTICK	Mar 15, 1988	Substantially Equivalent	Organon Teknika Corp.
K875262	V-TREND BETA-HCG DRY-SPOT TEST	Feb 02, 1988	Substantially Equivalent	Texas Immunology, Inc.
K874638	V-TREND BETA-HCG TEST	Jan 21, 1988	Substantially Equivalent	Texas Immunology, Inc.
K871294	ACU-PREG-AL SLIDE TEST	May 12, 1987	Substantially Equivalent	Papibris Scientific, Inc.
K863741	IMMUNO-CEPT D (BETA-MONOCLONAL)	Nov 13, 1986	Substantially Equivalent	Immunostics Co., Inc.
K861211	MONO ACU-SLIDE TEST	Nov 05, 1986	Substantially Equivalent	Cal-Tech Diagnostics, Inc.
K863198	PREGNASLIDE	Sep 29, 1986	Substantially Equivalent	Armkel, LLC
K861703	LEECO CONCEP-7-BHCG (EIA) II (MODIFIED)	Jul 29, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K862044	DELFIA (TM) HCG KIT	Jul 11, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K861212	DIRECT ACU-SLIDE TEST	Jul 07, 1986	Substantially Equivalent	Cal-Tech Diagnostics, Inc.
K862083	HYGEIA SCIENCES URINE HCG FLOW THORUGH ASSAY	Jul 02, 1986	Substantially Equivalent	Hygeia Sciences
K860945	DIRECTACLONE CG SLIDE PREGNANCY TEST	May 02, 1986	Substantially Equivalent	Pacific Biotech, Inc.
K854670	TERUMO SENSIBEAD EIG HCG KIT	Feb 13, 1986	Substantially Equivalent	Terumo Medical Corp.
K853247	ACU-SLIDE-TEST	Sep 04, 1985	Substantially Equivalent	Cal-Tech Diagnostics, Inc.
K852286	DIRRECT AGGLUTINATION(DAG) PREGNANCY TEST	Jul 09, 1985	Substantially Equivalent	Sero-Immuno Diagnostics, Inc.
K852066	PREGNANCY CARD TEST	Jun 25, 1985	Substantially Equivalent	Em Diagnostic Systems, Inc.
K850604	PRECO PREGNANCY RAPID CARD TEST, HEM #2028	Apr 08, 1985	Substantially Equivalent	Preco, Inc.
K844346	FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES	Mar 04, 1985	Substantially Equivalent	Fisher Diagnostics
K844914	ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN	Feb 12, 1985	Substantially Equivalent	Abbott Laboratories
K844347	FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT	Jan 23, 1985	Substantially Equivalent	Fisher Diagnostics
K842544	STANBIO QUICK-TELL MONOCLONAL INDIRECT	Sep 21, 1984	Substantially Equivalent	Stanbio Laboratory
K842314	DUOCLON COLOR-CEPT	Aug 24, 1984	Substantially Equivalent	Organon, Inc.
K842181	BETA-HCG HEMAGGLUTINATION TEST	Aug 22, 1984	Substantially Equivalent	Sero-Immuno Diagnostics, Inc.
K842110	SLIDE PREGNANCY TEST	Jul 12, 1984	Substantially Equivalent	Immunostics Co., Inc.
K841853	PREG-BETA ONE HOUR TUBE TEST	Jun 22, 1984	Substantially Equivalent	Intl. Diagnostic, Inc.
K840833	PREG BETA BLUS SLIDE	May 30, 1984	Substantially Equivalent	Intl. Diagnostic, Inc.
K840738	PLUS URINE HCG ASSAY	Apr 19, 1984	Substantially Equivalent	Monoclonal Antibodies, Inc.
K840650	B-NEOCEPT 30	Apr 04, 1984	Substantially Equivalent	Organon, Inc.
K834346	BHCG-CHECK	Feb 04, 1984	Substantially Equivalent	Diagnostic Technology, Inc.
K832867	FERTITUBE PREGNANCY TEST #1120	Feb 03, 1984	Substantially Equivalent	Stanbio Laboratory
K833137	ORTHO B-HCG SLIDE TEST FOR PREGNANCY	Jan 18, 1984	Substantially Equivalent	Ortho Diagnostic Systems, Inc.
K833504	PREGNASTICK URINE HCG KIT	Jan 09, 1984	Substantially Equivalent	Monoclonal Antibodies, Inc.
K833156	QUIDEL HCG ENZYME IMMUNOASSAY KIT	Nov 25, 1983	Substantially Equivalent	Quidel Corp.
K832918	PREGNA-TEC	Nov 03, 1983	Substantially Equivalent	Medilab Corp.
K832879	B-SLIDE PREGNATE PREGNANCY TEST KIT	Oct 28, 1983	Substantially Equivalent	Fisher Scientific Co., LLC
K832640	QUICK-TELL INDIRECT PREGNANCY TEST	Oct 04, 1983	Substantially Equivalent	Stanbio Laboratory
K832599	EARLY IN HOME PREGNANCY TEST	Sep 20, 1983	Substantially Equivalent	Warner-Lambert Co.
K832557	FERTITELL DIRECT PREGNANCY TEST #1100	Sep 12, 1983	Substantially Equivalent	Stanbio Laboratory
K832527	PREGNA-TEC	Sep 12, 1983	Substantially Equivalent	Medilab Corp.
K832473	GAMMA SLIDE TEST FOR PREGNANCY	Aug 16, 1983	Substantially Equivalent	Gamma Biologicals, Inc.
K831775	UCG-BETA SLIDE MONOCLONAL	Aug 11, 1983	Substantially Equivalent	Armkel, LLC
K831535	E.P.T. PLUS TM	Jun 30, 1983	Substantially Equivalent	Warner-Lambert Co.
K831468	B HCG-CHECK	Jun 22, 1983	Substantially Equivalent	Diagnostic Technology, Inc.
K831466	HCG-CHECK	Jun 22, 1983	Substantially Equivalent	Diagnostic Technology, Inc.
K831383	EVENT-TEST SLIDE	Jun 22, 1983	Substantially Equivalent	Icl Scientific
K831339	NEO-PREGNOSTICON DUOCLON TUBE TEST	Jun 08, 1983	Substantially Equivalent	Organon, Inc.
K831366	TESTCORP PREG	Jun 02, 1983	Substantially Equivalent	Catheter Technology Corp.
K831361	BETA-PREG	Jun 02, 1983	Substantially Equivalent	Catheter Technology Corp.
K831155	B-CLONE HCG ASSAY	Jun 02, 1983	Substantially Equivalent	Monoclonal Antibodies, Inc.
K831180	PREGNA-CERT, SLIDE PREGNANCY TEST	May 27, 1983	Substantially Equivalent	Diagnostic Specialties
K831125	BTC URINE LCG ASSAY	May 05, 1983	Substantially Equivalent	Btc Diagnostics, Inc.
K830156	HCG SCREENING TEST	Feb 09, 1983	Substantially Equivalent	Tago, Inc.
K823682	BETA FFIRM TEST	Jan 07, 1983	Substantially Equivalent	Organon, Inc.
K821676	PREG-PHILE B	Jul 16, 1982	Substantially Equivalent	Bio Diagnostic Systems, Inc.
K821552	PREG-KNOW	Jun 11, 1982	Substantially Equivalent	Immuno Pathology Labs
K821387	PREG/TEX PREGNANCY TEST	Jun 02, 1982	Substantially Equivalent	Texas Immunology, Inc.
K812789	ACU-SLIDE TEST	Dec 17, 1981	Substantially Equivalent	C.F. Medical, Inc.
K812788	A-1 TEST	Dec 17, 1981	Substantially Equivalent	C.F. Medical, Inc.
K812967	ACCURATE BETA	Nov 06, 1981	Substantially Equivalent	Organon, Inc.
K812924	ANSWER (R)	Nov 02, 1981	Substantially Equivalent	Armkel, LLC
K812334	B-NEOCEPT	Sep 01, 1981	Substantially Equivalent	Organon, Inc.
K812261	ACCURATE I	Aug 31, 1981	Substantially Equivalent	Organon, Inc.
K811940	OREIA II, B-HCG	Aug 03, 1981	Substantially Equivalent	Organon, Inc.
K811941	NEOCEPT	Jul 27, 1981	Substantially Equivalent	Organon, Inc.
K810581	FACT* HOME PREGNANCY TEST	Mar 17, 1981	Substantially Equivalent	Ortho Pharmaceutical Corp.
K802974	RAPI-DOT	Dec 19, 1980	Substantially Equivalent	Organon, Inc.
K802660	ANSWER AT-HOME PREGNANCY TEST KIT	Nov 24, 1980	Substantially Equivalent	Armkel, LLC
K802450	GESTATE SLIDE EIKEN KIT AGG. METHOD HUM	Oct 31, 1980	Substantially Equivalent	Syn-Kit, Inc.
K802435	UCG-BETA SLIDE	Oct 23, 1980	Substantially Equivalent	Armkel, LLC
K802421	UCG-BETA STAT	Oct 23, 1980	Substantially Equivalent	Armkel, LLC
K802343	PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO	Oct 10, 1980	Substantially Equivalent	Intl. Diagnostic, Inc.
K802334	IN-HOME EARLY PREGNANCY TEST KIT	Oct 10, 1980	Substantially Equivalent	Health Diagnostics Corp.
K800055	H-I-M-TEST FOR DETECTING HUMAN CHOR. GON	Jan 29, 1980	Substantially Equivalent	Technam, Inc.
K792657	SENSI-SLIDE	Jan 16, 1980	Substantially Equivalent	Hoffmann-La Roche, Inc.
K792027	PREGTELL I	Oct 30, 1979	Substantially Equivalent	Central Biological Co.
K791706	BE-SURE	Oct 17, 1979	Substantially Equivalent	Precision Products Corp.
K791609	BE-SURE	Oct 02, 1979	Substantially Equivalent	Biologics Intl., Inc.
K791309	UCG-LYPHOTEST	Jul 30, 1979	Substantially Equivalent	Wampole Laboratories
K790898	PREG-TEX	Jul 30, 1979	Substantially Equivalent	Biologics Intl., Inc.
K790734	PREGNOSTICON PREGNANCY TEST KIT	Jun 15, 1979	Substantially Equivalent	Organon, Inc.
K782166	SLIDE TEST FOR PREGNANCY, GRAVINDEX 90	Apr 04, 1979	Substantially Equivalent	Ortho Diagnostics, Inc.
K782063	PREGNANCY, SENSIDEX TUBE TEST	Apr 04, 1979	Substantially Equivalent	Ortho Diagnostics, Inc.
K790267	SENSI-TEX	Mar 21, 1979	Substantially Equivalent	Hoffmann-La Roche, Inc.
K790002	PREGNANCY TEST KIT, DAISY 2 IN HOME	Feb 01, 1979	Substantially Equivalent	Boehringer Mannheim Corp.
K781049	ACU-TEST IN-HOME PREGNANCY TEST	Jun 29, 1978	Substantially Equivalent	Williams, the J.B. Co., Inc.
K771514	PREGNANCY TEST KIT	Sep 12, 1977	Substantially Equivalent	Generic Laboratory, Ltd.