Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
The Liver/Kidney Microsome Type 1 (LKM-1) Autoantibody Test is an in vitro diagnostic immunology device used to detect anti-LKM-1 antibodies in patient serum, which are associated with autoimmune hepatitis type 2 (AIH-2) and assist in its diagnosis and differentiation from other liver diseases. Classified as FDA Class 2, it requires 510(k) premarket clearance under regulation 866.5660 (Immunology specialty). This device is eligible for third-party 510(k) review.
Research product code NBS in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- NBS
- Device Class
- FDA class 2
- Regulation Number
- 866.5660
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Sep 06, 2017 | Substantially Equivalent | Inova Diagnostics, Inc. |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Sep 11, 2012 | Substantially Equivalent | Euroimmun US |
| K000535 | QUANTA LITE LKM-1 ELISA | Jun 07, 2000 | Substantially Equivalent | Inova Diagnostics, Inc. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.