510(k) K091468

Clearance Details

Decision

SESE (Substantially Equivalent)

Decision Date

November 20, 2009

Date Received

May 18, 2009

Clearance Type

Traditional

Expedited Review

No

Third Party Review

No

Device Classification

Device Name

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Device Class

Class II

Regulation Number

866.5660

Review Panel

IM

Submission Type

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.