FDA product code NST: Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
NST is the FDA product code for autoantibodies, acetylcholine receptor, acetylcholine blocking and non-blocking. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel. FDA has cleared 4 510(k) submissions under NST, from 3 different applicants. The average 510(k) review took 154 days (median 153).
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.
Classification
| Field | Value |
|---|---|
| Device name | Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking |
| Device class | Class II |
| Regulation | 21 CFR 866.5660 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every NST clearance
Top NST applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Kronus Market Development Associates, Inc. | 2 | 2008-06-17 |
| Ivd Technologies | 1 | 2009-11-20 |
| Ibl-Hamburg GmbH | 1 | 2005-11-18 |
Most recent NST clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K091468 | Ivd Technologies | IVD TECHNOLOGIES ACHRAB TEST KIT | 2009-11-20 | 186 |
| K080523 | Kronus Market Development Associates, Inc. | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | 2008-06-17 | 112 |
| K051144 | Ibl-Hamburg GmbH | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA | 2005-11-18 | 198 |
| K042248 | Kronus Market Development Associates, Inc. | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | 2004-12-17 | 120 |
Recalls for NST devices
openFDA lists no recalls for product code NST.
Frequently asked questions
What is FDA product code NST?
NST is the FDA product code for autoantibodies, acetylcholine receptor, acetylcholine blocking and non-blocking. It is a Class II device, regulated under 21 CFR 866.5660 and reviewed by the Immunology panel.
What device class is NST?
Class II, regulation 21 CFR 866.5660. Typical premarket route: 510(k).
How long does a 510(k) take for product code NST?
Across 4 cleared submissions the average was 154 days from receipt to decision (median 153).
Which companies have the most NST clearances?
Kronus Market Development Associates, Inc. (2); Ivd Technologies (1); Ibl-Hamburg GmbH (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NST
- Run a recall and safety report across every NST manufacturer
- Watch product code NST for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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