K090755 is an FDA 510(k) clearance for the QUANTA LITE APS/PT IGG AND IGM ELISA. This device is classified as a Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex (Class II - Special Controls, product code OPN).
Submitted by Inova Diagnostics, Inc. (San Diego, US). The FDA issued a Cleared decision on February 1, 2010, 318 days after receiving the submission on March 20, 2009.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660. For The Detection Of Autoantibodies To Phosphatidylserine (ps), Prothrombin (pt), Or Phosphatidylserine/prothrombin (ps/pt) Complex In Human Serum Or Plasma. To Aid In The Diagnosis Of Certain Autoimmune Thrombotic Disorders Such As Anti-phospholipid Syndrome And Those Secondary To Systemic Lupus Erythematosus Or Other Lupus-like Diseases.
| 510(k) Number | K090755 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 2009 |
| Decision Date | February 01, 2010 |
| Days to Decision | 318 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | OPN — Auto-antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/prothrombin Complex |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |
| Definition | For The Detection Of Autoantibodies To Phosphatidylserine (ps), Prothrombin (pt), Or Phosphatidylserine/prothrombin (ps/pt) Complex In Human Serum Or Plasma. To Aid In The Diagnosis Of Certain Autoimmune Thrombotic Disorders Such As Anti-phospholipid Syndrome And Those Secondary To Systemic Lupus Erythematosus Or Other Lupus-like Diseases |