NIY · Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis
Immunology · 21 CFR 866.5660 · Class 2
Overview
| Product Code | NIY |
|---|---|
| Device Name | Autoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis |
| 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 |
|---|---|---|---|---|
| K113439 | EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG) | Euroimmun US | Apr 12, 2013 | SESE |
| K112221 | EUROIMMUN ANTI-SLA/LP ELISA(LGG) | Euroimmun US | Sep 11, 2012 | SESE |
| K021482 | QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA | Inova Diagnostics, Inc. | Jul 30, 2002 | SESE |
Top Applicants
- Euroimmun US — 2 clearances
- Inova Diagnostics, Inc. — 1 clearance
