Definition: A Respiratory Viral Panel Multiplex Nucleic Acid Assay Is A Qualitative In Vitro Diagnostic Device Intended To Simultaneously Detect And Identify Multiple Viral Nucleic Acids Extracted From Human Respiratory Specimens Or Viral Culture. The Detection
| Device Type ID | 3524 |
| Device Name | Respiratory Virus Panel Nucleic Acid Assay System |
| Physical State | A Qualitative In Vitro Diagnostic Assay Intended To Simultaneously Detect, Identify, And/or Differentiate Multiple Respiratory Virus Nucleic Acid Extracted From Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific |
| Technical Method | A Qualitative In Vitro Diagnostic Assay Intended To Simultaneously Detect, Identify, And/or Differentiate Multiple Respiratory Virus Nucleic Acid Extracted From Human Respiratory Specimens Or Viral Cultures. Detection And Differentiation Of Specific |
| Target Area | In Vitro Diagnostic Device |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| 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 | 866.3980 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OCC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3524 |
| Device | Respiratory Virus Panel Nucleic Acid Assay System |
| Product Code | OCC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Respiratory Viral Panel Multiplex Nucleic Acid Assay. |
| CFR Regulation Number | 866.3980 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
ALERE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
CEPHEID | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
FOCUS DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FOCUS DIAGNOSTICS, INC.: DBA DIASORIN MOLECULAR LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOLOGIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
JANSSEN PHARMACEUTICA N.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
LUMINEX MOLECULAR DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NANOSPHERE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUIDEL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
QUIDEL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ROCHE MOLECULAR SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Positive Result | 60 |
Incorrect Or Inadequate Test Results | 24 |
False Negative Result | 3 |
No Apparent Adverse Event | 1 |
| Total Device Problems | 88 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Alere Scarborough, Inc. Dba Binax, Inc. | II | Jul-16-2015 |
| 2 | Alere Scarborough, Inc. Dba Binax, Inc. | II | May-26-2015 |
| 3 | Focus Diagnostics Inc | II | Apr-02-2016 |
| 4 | Focus Diagnostics Inc | II | Jul-01-2014 |
| 5 | Focus Diagnostics Inc | II | Jan-28-2014 |
| 6 | Nanosphere, Inc. | II | Sep-23-2014 |
| 7 | Quidel Corporation | II | Feb-22-2017 |
| 8 | Roche Molecular Systems, Inc. | II | Jul-15-2016 |
| 9 | Roche Molecular Systems, Inc. | III | Jul-13-2016 |
| 10 | Roche Molecular Systems, Inc. | II | Sep-02-2015 |