Definition: The Device Is Used For The Detection, In Human Serum Or Plasma, Of Autoantibodies To SS-A 52. The Detection Of SS-A 52 Autoantibodies May Aid In The Diagnosis Of Systemic Lupus Erythematosus, Sjogren's Syndrome, Systemic Sclerosis, Polymyositis And D
| Device Type ID | 3079 |
| Device Name | Anti-ss-a 52 Autoantibodies |
| Physical State | The Device Consist Of Components/reagents To Detect And Semi-quantitatively Measure Autoantibodies To SS-A 52. |
| Technical Method | Enzyme-linked Immunosorbent Assay (ELISA) Or Enzyme Immunoassay (EIA) |
| Target Area | The Assay Is Performed By Testing Human Serum Or Plasma. |
| Regulation Description | Antinuclear Antibody Immunological Test System. |
| Regulation Medical Specialty | Immunology |
| Review Panel | Immunology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.5100 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OBE |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3079 |
| Device | Anti-ss-a 52 Autoantibodies |
| Product Code | OBE |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Antinuclear Antibody Immunological Test System. |
| CFR Regulation Number | 866.5100 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INOVA DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |