Product Code: JNB FDA class 2 21 CFR 862.1555

Ninhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine

Clinical Chemistry

This device is a fluorimetric clinical chemistry reagent system using ninhydrin and L-leucyl-L-alanine to measure phenylalanine in patient specimens, used in newborn screening programs and follow-up testing for phenylketonuria (PKU), a metabolic disorder in which phenylalanine accumulates due to deficiency of phenylalanine hydroxylase. It is classified as FDA Class 2, requiring 510(k) premarket notification, under 21 CFR 862.1555, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.

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Basic Information

Product Code: JNB
Device Class: FDA class 2
Regulation Number: 862.1555
Medical Specialty: Clinical Chemistry
Review Panel: CH
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K021541	NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT	Oct 28, 2002	Substantially Equivalent	Perkinelmer Life Sciences
K003584	NEOLYNX SCREENING APPLICATION MANAGER	Mar 19, 2001	Substantially Equivalent	Micromass, Inc.
K000754	QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT	Jun 19, 2000	Substantially Equivalent	Quantase , Ltd.
K984463	QUANTASE PHE/GAL SCREENING ASSAY	Feb 16, 1999	Substantially Equivalent	Quantase , Ltd.
K982307	WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000	Feb 02, 1999	Substantially Equivalent	Wallac, Inc.
K974047	ACCUWELL PHENYLALANINE ASSAY	Dec 05, 1997	Substantially Equivalent	Neometrics, Inc.
K963040	MANUAL PHENYLALANINE TEST	Oct 01, 1996	Substantially Equivalent	Bio-Rad
K960437	RADIAS PHENYLALANINE TEST	Aug 16, 1996	Substantially Equivalent	Bio-Rad
K961515	QUANTASE PHENYLALANINE ASSAY	Jun 12, 1996	Substantially Equivalent	Shield Diagnostics, Ltd.
K943547	PHENYLALANINE TEST KIT	Jan 26, 1996	Substantially Equivalent	Isolab, Inc.
K926106	IMMUCHEM PHE-MW EA	Feb 08, 1995	Substantially Equivalent	Icn Biomedicals, Inc.
K922547	QUANTASE PHENYLALANINE ASSAY	Oct 13, 1994	Substantially Equivalent	Porton Cambridge , Ltd.
K891070	PHENYLALANINE (NINHYDRIN REACTION)	Oct 27, 1989	Substantially Equivalent	Alpkem Corp.
K813449	PHE/TYR KINETIC UV TEST SET	Dec 31, 1981	Substantially Equivalent	P-L Biochemicals, Inc.
K813171	PHENYLALANINE UV KINETIC TEST KIT	Dec 03, 1981	Substantially Equivalent	Biochemicals, Inc.