Product Code: CHP FDA class 1 21 CFR 862.1260

Radioimmunoassay, Estradiol

Clinical Chemistry

The Radioimmunoassay, Estradiol test system (product code CHP) is an in-vitro diagnostic device used in clinical chemistry to measure estradiol, the predominant form of estrogen, in serum or plasma using a radioimmunoassay technique, supporting evaluation of reproductive endocrinology and hormone-related conditions. 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 862.1260 in the Clinical Chemistry medical specialty.

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Basic Information

Product Code: CHP
Device Class: FDA class 1
Regulation Number: 862.1260
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 50 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K041349	LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM	Sep 24, 2004	Substantially Equivalent	Ibl GmbH
K973901	17 B-ESTRADIOL (ELISA)	Nov 24, 1997	Substantially Equivalent	Kmi Diagnostics, Inc.
K973743	ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER	Oct 31, 1997	Substantially Equivalent	Beckman Instruments, Inc.
K970386	ACS ESTADIOL-6 II	Jun 04, 1997	Substantially Equivalent	Chiron Diagnostics Corp.
K970643	VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)	Mar 18, 1997	Substantially Equivalent	Johnson & Johnson Clinical Diagnostics, Inc.
K970126	ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)	Feb 25, 1997	Substantially Equivalent	Bio-Rad Laboratories, Inc.
K965109	ELECSYS ESTRADIOL ASSAY	Feb 18, 1997	Substantially Equivalent	Boehringer Mannheim Corp.
K955647	VIDAS ESTRADIOL II (E2II) ASSAY	Feb 06, 1996	Substantially Equivalent	Biomerieux Vitek, Inc.
K954697	CIBA CORNING ACS ESTRADIOL-6 ASSAY	Dec 13, 1995	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K953605	ULTRA-SENSITIVE ESTRADIOL	Oct 02, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K951360	ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM	May 02, 1995	Substantially Equivalent	Bayer Corp.
K946199	AURAFLEX(R) ESTRADIOL	Apr 03, 1995	Substantially Equivalent	Organon Teknika Corp.
K943193	COAT-A-COUNT(R) ESTRADIOL-6	Feb 23, 1995	Substantially Equivalent	Diagnostic Products Corp.
K941168	CLINICAL ASSAYS GAMMACOAT [125] ESTRADIOL RADIOIMMUNOASSAY KIT	Sep 07, 1994	Substantially Equivalent	Incstar Corp.
K932926	IMMULITE ESTRADIOL	Jan 10, 1994	Substantially Equivalent	Diagnostic Products Corp.
K932715	CIBA CORNING ACS ESTRADIOL IMMUNOASSAY	Dec 03, 1993	Substantially Equivalent	Ciba Corning Diagnostics Corp.
K932084	AIA-PACK E2 ASSAY	Nov 09, 1993	Substantially Equivalent	Tosoh Medics, Inc.
K933464	STRATUS ESTRADIOL FLUOROMETRIC ENZYME IMMUNOASSAY	Oct 22, 1993	Substantially Equivalent	Baxter Diagnostics, Inc.
K933066	OPUS ESTRADIOL	Sep 08, 1993	Substantially Equivalent	Pb Diagnostic Systems, Inc.
K931740	COTUBE ESTRADIOL RADIOIMMUNOASSAY	Aug 16, 1993	Substantially Equivalent	Bio-Rad
K925498	VIDAS ESTRADIOL (E2) ASSAY	Feb 12, 1993	Substantially Equivalent	Biomerieux Vitek, Inc.
K920047	IMX ESTRADIOL	Feb 18, 1992	Substantially Equivalent	Abbott Laboratories
K913162	ENZYMUN-TEST ESTRADIOL	Sep 27, 1991	Substantially Equivalent	Boehringer Mannheim Corp.
K912917	MILENIA ESTRADIOL	Jul 30, 1991	Substantially Equivalent	Diagnostic Products Corp.
K912318	ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE)	Jul 25, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K911396	SR1 ESTRADIOL ENZYME IMMUNOASSAY	May 28, 1991	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K910249	STRATUS ESTRADIOL FLUOREMETRIC ENZYME	Feb 13, 1991	Substantially Equivalent	Baxter Healthcare Corp
K902358	MODIFIED DELFIA ESTRADIOL KIT	Jun 18, 1990	Substantially Equivalent	Pharmacia, Inc.
K896145	ESTRADIOL SEROZYME IMMUNOENZYMETRIC ASSAY	Dec 27, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K896270	AMERLITE ESTRADIOL-60 ASSAY LAN.0081/2081	Dec 12, 1989	Substantially Equivalent	Amersham Corp.
K890645	ESTRADIOL MAIACLONE RADIOIMMUNOASSAY KIT	Mar 08, 1989	Substantially Equivalent	Serono-Baker Diagnostics, Inc.
K884105	AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT)	Nov 16, 1988	Substantially Equivalent	Amersham Corp.
K882343	TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT	Jul 01, 1988	Substantially Equivalent	Terumo Medical Corp.
K882173	DELFIA ESTRADIOL KIT	Jun 24, 1988	Substantially Equivalent	Pharmacia, Inc.
K873550	DSL ACTIVE ESTRADIOL RIA (DSL #4300)	Feb 18, 1988	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K870405	DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400)	Jun 08, 1987	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K862603	DOUBLE ANTIBODY ESTRADIOL RIA KIT	Aug 19, 1986	Substantially Equivalent	Diagnostic Products Corp.
K861361	ESTRADIOL MAIA RIA KIT MAGNETIC SEPARATION PHASE	Jun 27, 1986	Substantially Equivalent	Serono Diagnostics, Inc.
K853866	PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS	Oct 15, 1985	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K853208	125I ESTRADIOL DIRECT RADIOIMMUNOASSAY	Aug 19, 1985	Substantially Equivalent	Travenol Laboratories, S.A.
K851540	ESTRADIOL DIRECT RIA KIT	Jun 06, 1985	Substantially Equivalent	Biotecx Laboratories, Inc.
K841947	ESTRADIOL DIRECT RADIOIMMUNOASSAY KIT	Jun 25, 1984	Substantially Equivalent	Sorin Biomedica, Fiat, USA, Inc.
K840051	COAT-A-COUNT ESTRADIOL KIT	Mar 23, 1984	Substantially Equivalent	Diagnostic Products Corp.
K834586	LEECO E2 QUANT DIAG. TEST KIT	Mar 09, 1984	Substantially Equivalent	Leeco Diagnostics, Inc.
K820329	ESTRADIOL KIT BY RIA	Mar 04, 1982	Substantially Equivalent	Immuchem Corp.
K810695	ESTRIOL RADIOIMMUNOASSAY TEST KIT	Mar 31, 1981	Substantially Equivalent	Serono Laboratories, Inc.
K810204	17B ESTRADIOL	Mar 27, 1981	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K800920	NORDICLAB ESTRADIOL RIA TEST	May 14, 1980	Substantially Equivalent	Nordiclab Intl.
K791652	ESTRADIOL KIT BY RIA	Sep 27, 1979	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K790679	ESTRADIOL RIA KIT	May 23, 1979	Substantially Equivalent	Serono Laboratories, Inc.