Product code NST

Device name

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Medical specialty

Immunology

Device class

2

Regulation number

866.5660

Review panel

IM

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

Y

Summary malfunction reporting

Eligible

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.

Source

FDA openFDA device classification dataset