NWG — Autoantibodies, Glutamic Acid Decarboxylase (Gad) Class II

FDA Device Classification

Classification Details

Product Code: NWG
Device Class: Class II
Regulation Number: 866.5660
Submission Type
Review Panel: IM
Medical Specialty: Immunology
Implant: No

Definition

The device is used for the semi-quantitative determination of glutamic acid decarboxylase (GAD) autoantibodies in human serum as an aid in the diagnosis of Type I diabetes mellitus (autoimmune mediated diabetes).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K072135	kronus market development associates	KRONUS GAD AUTOANTIBODY ELISA ASSAY KIT	November 7, 2007
K051061	kronus market development associates	KRONUS GLUTAMIC ACID DECARBOXYLASE ANTIBODY KIT	November 4, 2005