Product Code: CFL FDA class 1 21 CFR 862.1370

Radioimmunoassay, Human Growth Hormone

Clinical Chemistry

The Human Growth Hormone Radioimmunoassay is a clinical chemistry device that uses radiolabeled antibody competition to quantify human growth hormone (hGH) levels in serum, used in the diagnosis of growth hormone deficiency, acromegaly, and monitoring of growth hormone therapy. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CFL, regulated under 21 CFR 862.1370, within the Clinical Chemistry medical specialty. No special flags apply to this device.

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FEI Numbers

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Basic Information

Product Code: CFL
Device Class: FDA class 1
Regulation Number: 862.1370
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 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K972761	SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY	Sep 25, 1997	Substantially Equivalent	Sealite Sciences, Inc.
K971353	DSL ACTIVE NON-EXTRACTION IGF-I ELISA	May 12, 1997	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K970701	DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)	Apr 02, 1997	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K962758	DSL 9100 IGF-II IRMA	Aug 30, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K961678	HUMAN GROWTH HORMONE IMMUNOASSAY KIT	Jul 08, 1996	Substantially Equivalent	Nichols Institute Diagnostics
K961172	DSL ACTIVE NON-EXTRACTION IGF-I IRMA	Apr 23, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K960551	DSL ACTIVE HUMAN GROWTH HORMONE ELISA	Mar 06, 1996	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K955376	IMMULITE HGH	Feb 16, 1996	Substantially Equivalent	Diagnostic Products Corp.
K955390	INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY	Dec 29, 1995	Substantially Equivalent	Corning Nichols Diagnostics
K952505	INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA)	Jul 03, 1995	Substantially Equivalent	Nichols Institute
K946247	IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3	Jun 23, 1995	Substantially Equivalent	Nichols Institute
K951752	ACTIVE IGF-I ELISA	May 10, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K951707	DSL ACTIVE IFGBP-3 ELISA	May 10, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K950510	OCTEIA IGF-1 KIT	Apr 05, 1995	Substantially Equivalent	Immunodiagnostic Systems , Ltd.
K950228	DSL ACTIVE IGFBP-3 IRMA (DSL 6600)	Feb 22, 1995	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K930047	DSL IGFBP-3 RIA (DSL 6700)	Jul 06, 1994	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K921868	ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT	Jan 03, 1994	Substantially Equivalent	Endocrine Sciences Products
K930484	DELFIA(R) HGH KIT	May 11, 1993	Substantially Equivalent	Wallac OY
K920299	MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT	Mar 04, 1992	Substantially Equivalent	Medix Biotech, Inc.
K912858	LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY	Jul 30, 1991	Substantially Equivalent	London Diagnostics, Inc.
K905757	AIA-PACK HGH	Jan 25, 1991	Substantially Equivalent	Tosoh Medics, Inc.
K905098	ELEGANCE GH ELISA	Dec 06, 1990	Substantially Equivalent	Bioclone Australia Pty , Ltd.
K896808	IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I	Jan 19, 1990	Substantially Equivalent	Nichols Institute Diagnostics
K896643	HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015	Dec 29, 1989	Substantially Equivalent	Medix Biotech, Inc.
K882823	FIAGEN HGH FLUOROIMMUNOASSAY KIT	Aug 30, 1988	Substantially Equivalent	Cyberfluor, Inc.
K875229	DSL SOMATOMEDIN-C (DSL #5600)	Jul 01, 1988	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K860228	SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA	Feb 28, 1986	Substantially Equivalent	Boots-Celltech Diagnostics, Inc.
K852299	TERUMO SENSIBEAD EIA HGH KIT	Jul 09, 1985	Substantially Equivalent	Terumo Medical Corp.
K850892	SOMATOMEDIN C BY RADIOIMMUNOASSAY	Jun 06, 1985	Substantially Equivalent	Immuno Nuclear Corp.
K851259	HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT	May 13, 1985	Substantially Equivalent	Nichols Institute Diagnostics
K841088	SOMATOMEDIN-C RADIOIMMUNOASSAY KIT	Oct 22, 1984	Substantially Equivalent	Nichols Institute Diagnostics
K841094	HUMAN GROWTH HORMONE RIA KIT	May 07, 1984	Substantially Equivalent	Diagnostic Products Corp.
K831073	DAC-CEL HCG-MCA KIT RD52	Sep 01, 1983	Substantially Equivalent	Wellcome Diagnostics
K821366	TANDEM - HGH KIT	Jun 10, 1982	Substantially Equivalent	Hybritech, Inc.
K803280	HUMAN GROWTH HORMONE-RADIOIMM. KIT	Jan 16, 1981	Substantially Equivalent	Immuno Nuclear Corp.
K780347	RIA SYS. FOR HUMAN GROWTH HORMONE	Apr 12, 1978	Substantially Equivalent	Calbiochem-Behring Corp.