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U.S. Department of Health and Human Services

Product Classification

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Device autoantibodies, acetylcholine receptor, acetylcholine blocking and non-blocking
Regulation Description Multiple autoantibodies immunological test system.
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.
Regulation Medical Specialty Immunology
Review Panel Immunology
Product CodeNST
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 866.5660
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible