K021482 is an FDA 510(k) clearance for the QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA. This device is classified as a Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis (Class II - Special Controls, product code NIY).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on July 30, 2002, 83 days after receiving the submission on May 8, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis.
| 510(k) Number | K021482 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2002 |
| Decision Date | July 30, 2002 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NIY — Autoantibodies, Anti-soluble Liver Antigen (sla), Autoimmune Hepatitis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | Elisa For The Detection Of Anti-sla (soluble Liver Antigen) Antibody Of The Igg Class. Intended To Aid In The Diagnosis Of Conditions With Elevated Levels Of Anti-sla Antibody Including Autoimmune Hepatitis |