Antibodies, Anti-Actin, Anti-Smooth Muscle
The Anti-Actin/Anti-Smooth Muscle Antibodies test is an in vitro diagnostic device used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum, serving as an aid in the diagnosis of certain autoimmune liver diseases such as autoimmune hepatitis. It is classified as FDA Class 2 (Special Controls), requiring 510(k) clearance, under product code NJF and regulation 21 CFR 866.5120 in the Immunology specialty. The device is eligible for third-party review and carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NJF
- Device Class
- FDA class 2
- Regulation Number
- 866.5120
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
Definition
The device is used for the semi-quantitative detection of IgG antibodies to the actin component of smooth muscle in human serum as an aid in the diagnosis of certain autoimmune liver diseases, e.g. autoimmune hepatitis.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K021648 | QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA | Sep 20, 2002 | Substantially Equivalent | Inova Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.