Product Code: JLX FDA class 1 21 CFR 862.1395

Radioimmunoassay, 17-Hydroxyprogesterone

Clinical Chemistry

This device is a radioimmunoassay system used to measure 17-hydroxyprogesterone in patient serum, used primarily in newborn screening programs and follow-up testing for congenital adrenal hyperplasia caused by 21-hydroxylase deficiency, where elevated levels indicate impaired cortisol synthesis. It is classified as FDA Class 1, the lowest risk category, requiring only general controls with no premarket notification. The product code is JLX, regulated under 21 CFR 862.1395, and assigned to the Clinical Chemistry medical specialty.

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FEI Numbers

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Basic Information

Product Code: JLX
Device Class: FDA class 1
Regulation Number: 862.1395
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 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K100682	GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U	Jul 23, 2010	Substantially Equivalent	Wallac OY
K081922	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Apr 16, 2009	Substantially Equivalent	Wallac OY
K062534	ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE	Jan 29, 2008	Substantially Equivalent	Drg Intl., Inc.
K060452	ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH	Mar 13, 2007	Substantially Equivalent	Neo-Genesis
K050960	MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT	Jul 11, 2005	Substantially Equivalent	Wallac OY
K042425	AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Sep 30, 2004	Substantially Equivalent	Wallac OY
K042424	DELFIA NEONATAL 17A-OH-PROGESTERONE KIT	Sep 30, 2004	Substantially Equivalent	Wallac OY
K973350	BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST	Feb 09, 1998	Substantially Equivalent	Bio-Rad
K934178	ACCUSCREEN 17-HYDROXYPROGESTERONE	Mar 30, 1995	Substantially Equivalent	Neometrics, Inc.
K940233	NEOSCREEN ELISA HYDROXYPROGESTERONE	Dec 28, 1994	Substantially Equivalent	Pantex
K943148	DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)	Nov 10, 1994	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K912026	DELFIA(R) 17 -OH-PROGESTERON KIT	Jun 25, 1991	Substantially Equivalent	Pharmacia Diagnostics, Inc.
K911839	NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT	Jun 18, 1991	Substantially Equivalent	Pantex, Div. Bio-Analysis, Inc.
K894265	DSL 17A-OH PROGERSTERONE (DSL #6800)	Sep 07, 1989	Substantially Equivalent	Diagnostic Systems Laboratories, Inc.
K885198	17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA	Feb 23, 1989	Substantially Equivalent	Icn Biomedicals, Inc.
K874782	COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT	Feb 11, 1988	Substantially Equivalent	Diagnostic Products Corp.
K860335	COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT	Apr 24, 1986	Substantially Equivalent	Diagnostic Products Corp.
K834246	PROGESTERONE TEST SET 125I 17-OH	Feb 04, 1984	Substantially Equivalent	Wien Laboratories, Inc.
K771729	17-HYDROXYPROGESTERONE TEST SET	Oct 21, 1977	Substantially Equivalent	Wien Laboratories, Inc.