Definition: A Polymerase Chain Reaction (pcr)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (hsv) Dna Using Vaginal Swab Specimens.
| Device Type ID | 3535 |
| Device Name | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Physical State | Plasma, Serum, Swab, Culture Isolates |
| Technical Method | Polymerase Chain Reaction (PCR)-based Qualitative In Vitro Diagnostic Test For The Detection And Typing Of Herpes Simplex Virus (HSV) DNA |
| Target Area | Systemic |
| Regulation Description | Herpes Simplex Virus Serological Assays. |
| Regulation Medical Specialty | Microbiology |
| Review Panel | Microbiology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 866.3305 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OQO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3535 |
| Device | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Product Code | OQO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Herpes Simplex Virus Serological Assays. |
| CFR Regulation Number | 866.3305 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FOCUS DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INTELLIGENT MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QIAGEN SCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEEGENE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 4 |
False Positive Result | 2 |
| Total Device Problems | 6 |