510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NSTClass II

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

NST is the FDA product code for Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "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...". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NST
Device name
Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
FDA 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
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code NST

By decision year
4 clearances under product code NST with a decision year between 2004 and 2009, 2004 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code NST by decision year
YearClearances
20041
20051
20081
20091

Applicants with the most clearances

Product code NST
Applicants holding the most 510(k) clearances under product code NST
ApplicantClearances
Kronus Market Development Associates, Inc.2
Ibl-Hamburg GmbH1
Ivd Technologies1

Companies listing this code with FDA

Companies whose registered establishments list this code