NST — Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking Class II

FDA Device Classification

Classification Details

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

Definition

THE DEVICE IS AN IMMUNOASSAY INDICATED AS AN AID IN THE DIAGNOSIS OF MYASTHENIA GRAVIS, AN AUTOIMMUNE DISEASE CHARACTERIZED BY EXERCISE-INDUCED MUSCLE WEAKNESS TEMPORARILY RELIEVED BY CESSATION OF EXERCISE. AUTOANTIBODY, WHEN PRESENT IN SERUM, INTERFERES WITH THE BINDING OF ACETYLCHOLINE, A NEURAL TRANSMITTER AT THE JUNCTION OF NERVES WITH MUSCLES. AUTOANTIBODY CAN ALSO BIND TO OTHER PORTIONS OF THE ACETYLCHOLINE RECEPTOR WITHOUT INTERFERING WITH ACETYLCHOLINE BINDING. PRESENCE OF AUTOANTIBODY ALONG WITH CLINICAL SIGNS AND SYMPTOMS ARE USUALLY HIGHLY SUGGESTIVE OF MYASTHENIA GRAVIS. ACETYLCHOLINE RECEPTOR AUTOANTIBODY CAN ALSO OCCUR IN THE PRESENCE OF AUTOANTIBODIES TO OTHER BODY SUBSTANCES.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K091468ivd technologiesIVD TECHNOLOGIES ACHRAB TEST KITNovember 20, 2009
K080523kronus market development associatesKRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KITJune 17, 2008
K051144ibl-hamburgACETYLCHOLINE RECEPTOR AB (ARAB)RRANovember 18, 2005
K042248kronus market development associatesKRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KITDecember 17, 2004