Product Code: JKC FDA class 1 21 CFR 862.1245

Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)

Clinical Chemistry

This device is a radioimmunoassay system used to measure dehydroepiandrosterone (DHEA) and its sulfate (DHEAS) in patient specimens, used in the clinical evaluation of adrenal function, adrenal tumors, polycystic ovary syndrome, and congenital adrenal hyperplasia. It is classified as FDA Class 1, indicating low risk and requiring only general controls with no premarket notification. The product code is JKC, regulated under 21 CFR 862.1245, within the Clinical Chemistry medical specialty.

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Basic Information

Product Code: JKC
Device Class: FDA class 1
Regulation Number: 862.1245
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 28 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K040181	ACCESS DHEA-S REAGENT ASSAY	Mar 24, 2004	Substantially Equivalent	Beckman Coulter, Inc.
K003174	ELECSYS DHEA-S	Jan 17, 2001	Substantially Equivalent	Roche Diagnostics Corp.
K973897	DHEA-S	Nov 13, 1997	Substantially Equivalent	Kmi Diagnostics, Inc.
K962895	DSL DHEA-S-7	Sep 10, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K955114	DSL AACTIVE DHEA EIA KIT	Feb 23, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K950524	NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY	May 15, 1995	Substantially Equivalent	Nichols Institute
K942051	SR1 DHEA-S ENZYME IMMUNOASSAY	Jul 13, 1994	Substantially Equivalent	Serono Diagnostics, Inc.
K935014	ACTIVE DEHYDROEPIANDROSTERONE (DHEA)(DSL 9000)	May 09, 1994	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K935806	IMMULITE DHEA-S04	Apr 26, 1994	Substantially Equivalent	Diagnostic Products Corp.
K935469	SYNELISA DHEA-SULFATE	Mar 22, 1994	Substantially Equivalent	Elias U.S.A., Inc.
K931601	CHEMILUMINESCENCE DHEA-S IMMUNOASSAY	Jul 27, 1993	Substantially Equivalent	Nichols Institute
K903616	DSL ANDROSTANEDIOL GLUCURONIDE (DSL #6000)	Sep 10, 1990	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K891478	DSL 7900 ACTIVE DHEA-S (DSL #7900)	Apr 26, 1989	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K872879	DHEA-S RIA KIT	Oct 23, 1987	Substantially Equivalent	Endocrine Associates, Inc.
K853867	PANTEX DIRECT DHEA-S COATED TUBE RADIOIMMUNOASSAY	Oct 04, 1985	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K852847	SOPHEIA DHEA-SO4 EIA KIT	Aug 02, 1985	Substantially Equivalent	Diagnostic Products Corp.
K851239	ACTIVE DHEA-SULFATE DSL3500	Apr 25, 1985	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K843635	MATCHED COMPONENT SET FOR RADIOIMMUNO-	Sep 28, 1984	Substantially Equivalent	Cambridge Medical Technology
K842606	COAT-A-COUNT DHEA RIA KIT	Aug 17, 1984	Substantially Equivalent	Diagnostic Products Corp.
K842552	COAT-A-COUNT DHEA-SO4 RIA KIT	Aug 17, 1984	Substantially Equivalent	Diagnostic Products Corp.
K842555	DHEA-S DIRECT RIA KIT	Aug 07, 1984	Substantially Equivalent	Biotecx Laboratories, Inc.
K832154	DHEA-SULFATE I RIA KIT	Aug 16, 1983	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K823200	125 I-DEHYDROEPIANDROSTERONE SULFATE	Nov 29, 1982	Substantially Equivalent	Wien Laboratories, Inc.
K822140	IMMUCHEM COVALENT-COAT	Aug 05, 1982	Substantially Equivalent	Immuchem Corp.
K821145	I-DHEA-SULFATE RIA KIT 125	May 14, 1982	Substantially Equivalent	Nuclear Medical Systems, Inc.
K811906	DHEA-SULFATE DIRECT RIA KIT(125I)	Jul 23, 1981	Substantially Equivalent	Immunalysis Corporation
K802195	DEHYDROEPIANDROSTERONE SULFATE KIT RIA	Oct 23, 1980	Substantially Equivalent	Radioassay Systems Laboratories, Inc.
K792041	DHEA-SULFATE TEST SET	Oct 30, 1979	Substantially Equivalent	Wien Laboratories, Inc.