K021648 is an FDA 510(k) clearance for the QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA. This device is classified as a Antibodies, Anti-actin, Anti-smooth Muscle (Class II - Special Controls, product code NJF).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on September 20, 2002, 123 days after receiving the submission on May 20, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5120. 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) Number | K021648 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 20, 2002 |
| Decision Date | September 20, 2002 |
| Days to Decision | 123 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NJF — Antibodies, Anti-actin, Anti-smooth Muscle |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5120 |
| 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. |