Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking
The Acetylcholine Receptor Autoantibody (Blocking and Non-Blocking) device is an immunoassay used as an aid in the diagnosis of myasthenia gravis, an autoimmune disease characterized by exercise-induced muscle weakness. The assay detects autoantibodies in serum that interfere with the binding of acetylcholine at the neuromuscular junction, including both blocking and non-blocking antibody types. It is an FDA Class 2 device regulated under 21 CFR 866.5660 in the Immunology specialty, with product code NST, requiring 510(k) clearance. Third-party review is available. It is not an implant and does not provide life-sustaining support.
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Basic Information
- Product Code
- NST
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091468 | IVD TECHNOLOGIES ACHRAB TEST KIT | Nov 20, 2009 | Substantially Equivalent | Ivd Technologies |
| K080523 | KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT | Jun 17, 2008 | Substantially Equivalent | Kronus Market Development Associates, Inc. |
| K051144 | ACETYLCHOLINE RECEPTOR AB (ARAB)RRA | Nov 18, 2005 | Substantially Equivalent | Ibl-Hamburg GmbH |
| K042248 | KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT | Dec 17, 2004 | Substantially Equivalent | Kronus Market Development Associates, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.