NBS · Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | NBS |
|---|---|
| Device Name | Autoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1) |
| Regulation | 21 CFR 866.5660 |
| Device Class | Class 2 |
| Review Panel | Immunology |
| 3rd-Party Reviewable | Yes |
Identification
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | Inova Diagnostics, Inc. | Sep 6, 2017 | SESE |
| K112223 | EUROIMMUN ANTI-LKM-1 ELISA(LGG) | Euroimmun US | Sep 11, 2012 | SESE |
| K000535 | QUANTA LITE LKM-1 ELISA | Inova Diagnostics, Inc. | Jun 7, 2000 | SESE |
Top Applicants
- Inova Diagnostics, Inc. — 2 clearances
- Euroimmun US — 1 clearance
