Product Code: CFT FDA class 1 21 CFR 862.1625

Radioimmunoassay, Prolactin (Lactogen)

Clinical Chemistry

The Radioimmunoassay, Prolactin (Lactogen) test system (product code CFT) is an in-vitro diagnostic device used in clinical chemistry to measure prolactin (also known as lactogen) levels in serum or plasma via a radioimmunoassay technique. It is classified as FDA Class 1, the lowest risk tier, subject only to general controls and not requiring premarket notification. It falls under regulation 21 CFR 862.1625 in the Clinical Chemistry medical specialty.

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Basic Information

Product Code: CFT
Device Class: FDA class 1
Regulation Number: 862.1625
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 4

Device Characteristics

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GMP Exempt

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Implant

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Life Sustain/Support

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Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 80 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K971921	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	Jun 24, 1997	Substantially Equivalent	Monobind
K970281	VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS	Feb 25, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K970188	SEALITE SCIENCES, INC. AQUALITE PROLACTIN	Feb 20, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K964748	ELECSYS PROLACTIN ASSAY	Jan 21, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K960561	DSL ACTIVE PROLACTIN ELISA MODEL 10-4500	Apr 26, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K960060	DSL ACTIVE PROLACTIN IRMA	Feb 29, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K954680	ACCESS PROLACTIN ASSAY (MODIFICATION)	Oct 20, 1995	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K953656	ABBOTT IMX PROLACTIN(MODIFICATION)	Oct 03, 1995	Substantially Equivalent	Abbott Mfg., Inc.
K953657	ABBOTT AXSYM PROLACTIN(MODIFICATION)	Sep 25, 1995	Substantially Equivalent	Abbott Mfg., Inc.
K944698	AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1	Mar 21, 1995	Substantially Equivalent	Organon Teknika Corp.
K943811	ENZYME-LINKED FLUORESCENT IMMUNOASSAY	Nov 02, 1994	Substantially Equivalent	Biomerieux Vitek, Inc.
K935675	AXSYM PROLACTIN	Jun 21, 1994	Substantially Equivalent	Abbott Laboratories
K941220	DUPONT ACA PLUS PROLACTIN (PROL) METHOD	Jun 03, 1994	Substantially Equivalent	Dupont Medical Products
K941175	ACCESS PROLACTIN	Jun 02, 1994	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K930305	COBAS CORE PROLACTIN EIA	Aug 19, 1993	Substantially Equivalent	Roche Diagnostic Systems, Inc.
K926386	VISTA PROLACTIN ASSAY	Mar 29, 1993	Substantially Equivalent	Syva Co.
K925846	IMMULITE PROLACTIN	Mar 05, 1993	Substantially Equivalent	Diagnostic Products Corp.
K922715	IMMUCHEM PRL-MW ELISA	Oct 05, 1992	Substantially Equivalent	Icn Biomedicals, Inc.
K922170	AMERLITE PROLACTIN-30 ASSAY	Sep 02, 1992	Substantially Equivalent	Eastman Kodak Company
K920921	ELISA TUBE PROLACTIN TEST KIT	Apr 08, 1992	Substantially Equivalent	Bio Clinic Co.
K920345	PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED)	Mar 18, 1992	Substantially Equivalent	Medix Biotech, Inc.
K914135	AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086	Feb 18, 1992	Substantially Equivalent	Amersham Corp.
K914107	PROLACTIN IRMA IMMUNOMAG	Sep 30, 1991	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K913280	OPUS(R) PROLACTIN TEST SYSTEM	Aug 16, 1991	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K904714	CIBA CORNING ACS PROLACTIN IMMUNOASSAY	Nov 07, 1990	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K904483	ELEGANCE PROLACTIN ELISA	Nov 05, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K904458	LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION	Oct 12, 1990	Substantially Equivalent	London Diagnostics, Inc.
K902698	AFFINITY PROLACTIN TEST SYSTEM	Jul 19, 1990	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K901673	PROLACTIN (LACTOGEN) TEST SYSTEM	Jun 12, 1990	Substantially Equivalent	Baxter Healthcare Corp
K901578	COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2	Apr 19, 1990	Substantially Equivalent	Diagnostic Products Corp.
K900695	ENZYMUN TEST(R) PROLACTIN	Mar 30, 1990	Substantially Equivalent	Boehringer Mannheim Corp.
K896162	ABBOTT IMX PROLACTIN	Jan 19, 1990	Substantially Equivalent	Abbott Laboratories
K896641	MODIFIED PROLACTIN ENZYME IMMUNOASSAY TEST KIT	Dec 27, 1989	Substantially Equivalent	Medix Biotech, Inc.
K895380	SR1 PROLACTIN (PRL IMMUNOENZYMETRIC ASSAY	Oct 17, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K894988	CIBA CORNING MAGIC LITE PROLACTIN IMMUNOASSAY	Oct 12, 1989	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K895003	MILENIA(TM) PROLACTIN (MKPR1,5)	Sep 18, 1989	Substantially Equivalent	Diagnostic Products Corp.
K883878	AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)	Nov 01, 1988	Substantially Equivalent	Amersham Corp.
K883747	IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES	Nov 01, 1988	Substantially Equivalent	Diagnostic Products Corp.
K883269	PRL-QUANT	Sep 13, 1988	Substantially Equivalent	Leeco Diagnostics, Inc.
K881774	PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM	Jun 08, 1988	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K880296	LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY	Mar 24, 1988	Substantially Equivalent	London Diagnostics, Inc.
K880218	BINAX PROLACTIN IRMA DIAGNOSTIC KIT	Mar 01, 1988	Substantially Equivalent	Binax, Inc.
K874621	FIAGEN(TM) PROLACTIN CATALOGUE NUMBER: 102-201	Jan 11, 1988	Substantially Equivalent	Cyberfluor, Inc.
K873355	MEDIX BIOTECH PROLACTIN ENZYME IMMUNO. TEST KIT	Oct 09, 1987	Substantially Equivalent	Medix Biotech, Inc.
K873400	PROLACTIN MAIACLONE IMMUNORADIO. KIT, MAG SOL PHA	Sep 25, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K872862	PRL SEROZYME IMMUNOENZ. ASSAY KIT, MAG. SOLID PHAS	Sep 18, 1987	Substantially Equivalent	Serono Diagnostics, Inc.
K871542	HPROLACTIN KIT	May 14, 1987	Substantially Equivalent	Immuchem Corp.
K864439	BECKMAN EPSILON(TM) PROLACTIN TEST KIT	Jan 21, 1987	Substantially Equivalent	Beckman Instruments, Inc.
K864075	UBI MAGIWEL(TM) PROLACTIN QUANTATIVE	Dec 16, 1986	Substantially Equivalent	United Biotech, Inc.
K863860	TANDEM-M IMMUNOENZYMETRIC ASSAY FOR PROLACTIN	Nov 21, 1986	Substantially Equivalent	Hybritech, Inc.
K863240	PROLACTIN RIABEAD II DIAGNOSTIC KIT	Sep 29, 1986	Substantially Equivalent	Abbott Laboratories
K860823	ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT	Aug 19, 1986	Substantially Equivalent	Cis-Us, Inc.
K861271	SUCROSEP HUMAN PROLACTIN (HPR) IRMA	Jun 27, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K861542	DELFIA (TM) HUMAN PROLACTIN	Jun 17, 1986	Substantially Equivalent	Lkb Instruments, Inc.
K861945	LEE-BEAD PROLACTIN (EIA)	Jun 13, 1986	Substantially Equivalent	Leeco Diagnostics, Inc.
K860221	ENCORE PROLACTIN REAGENT	Mar 05, 1986	Substantially Equivalent	Hybritech, Inc.
K854805	ALLEGRO PROLACTIN IMMUNOASSAY SYSTEM	Jan 28, 1986	Substantially Equivalent	Nichols Institute Diagnostics
K854768	TERUMO SENSIBEAD EIA HPRL KIT	Jan 13, 1986	Substantially Equivalent	Terumo Medical Corp.
K851330	PROLACTIN SYSTEM BY RIA	Apr 29, 1985	Substantially Equivalent	American Bioclinical, Inc.
K850383	PRL QUIK RIA KIT	Mar 01, 1985	Substantially Equivalent	Pacific Biotech, Inc.
K843804	TANDEM - EPRL	Nov 13, 1984	Substantially Equivalent	Hybritech, Inc.
K842478	PROLACTIN IRMA	Sep 14, 1984	Substantially Equivalent	Euro-Diagnostics BV
K841118	PROLACTIN RIABEAD PROLACTIN RADIOIMM	May 11, 1984	Substantially Equivalent	Abbott Laboratories
K833925	COAT-A-COUNT NHS-PROLACTIN KIT AND	Jan 24, 1984	Substantially Equivalent	Diagnostic Products Corp.
K831345	RIANEN PROLACTIN 125I KIT	Jun 08, 1983	Substantially Equivalent	New England Nuclear
K830412	RADIOIMMUNOASSAY TEST SYSTEM PRL	Apr 05, 1983	Substantially Equivalent	Monobind
K823304	RIASET PROLACTIN RIA KIT	Dec 22, 1982	Substantially Equivalent	Immulok, Inc.
K822759	ABBOTT LABORATORIES PROLACTIN EIA	Oct 21, 1982	Substantially Equivalent	Abbott Laboratories
K821545	TANDEM PROLACTIN KIT	Jun 11, 1982	Substantially Equivalent	Hybritech, Inc.
K821305	PROLACTIN (125-I) RADIOIMMUNOASSAY KIT	May 24, 1982	Substantially Equivalent	Bd Becton Dickinson Vacutainer Systems Preanalytic
K813572	CENTRIA PROLACTIN TEST SET	Mar 26, 1982	Substantially Equivalent	Ventrex Laboratories, Inc.
K820039	LEECO PRL-QUANT DIAGNOSTIC TEST KIT	Jan 22, 1982	Substantially Equivalent	Leeco Diagnostics, Inc.
K812112	MARRIA-HPRL RIA KIT	Aug 13, 1981	Substantially Equivalent	Intl. Immunoassay Laboratories, Inc.
K810949	MRI PROLACTIN RIA KIT	Jul 10, 1981	Substantially Equivalent	Microanalytic Research, Inc.
K803273	PROLACTIN (125) RADIOIMMUNAOASSAY	Jan 16, 1981	Substantially Equivalent	Corning Medical & Scientific
K801849	LACTI-QUANT	Sep 16, 1980	Substantially Equivalent	Nuclear Medical Laboratories, Inc.
K801020	GAMMA PROLACTIN RADIOIMMUNOASSAY KIT-	Jul 08, 1980	Substantially Equivalent	Travenol Laboratories, S.A.
K800740	PROLACTIN RIA KIT	Apr 16, 1980	Substantially Equivalent	Amersham Corp.
K792166	125 I PROLACTIN HORMONE RIA KIT	Nov 13, 1979	Substantially Equivalent	Diagnostic Products Corp.
K790003	RIA KIT, PROLACTIN	Mar 12, 1979	Substantially Equivalent	Cis Radiopharmaceuticals, Inc.