DeviceClearance

Product code NST— Immunology

ACETYLCHOLINE RECEPTOR AB (ARAB)RRA

Classification name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
Device class
Class 2
Regulation
21 CFR 866.5660
Advisory panel
Immunology
Total cleared
4
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code NST under 21 CFR 866.5660, via openFDA

Market context for product code NST

FDA has cleared 4 devices under product code NST between 2004 and 2009, filed by 3 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code NST

Recent clearances under product code NST

Data sourced from openFDA. This site is unofficial and independent of the FDA.