Definition: The System Is A Clinical Multiplex Instrument Intended To Measure And Sort Multiple Signals Generated My Multiple Probes, Intercalating Dyes, Or Other Ligands In An Assay From A Clinical Sample. Signals May Be Generated By Fluorescence Or Other Pheno
| Device Type ID | 645 |
| Device Name | Real Time Nucleic Acid Amplification System |
| Physical State | Should Not Include Microarray Or Electrophoresis Detection Methods Or Instruments. |
| Technical Method | A Real-time Thermocycler Is Intended To Identify And/or Quantify The Presence Of Specific Sequences Of Double Stranded DNA, Amplified From A Biological Source And Labeled With Fluorescently Labeled Probes Or Through The Use Of Intercalating Dyes And |
| Target Area | N/A |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2570 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOI |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 645 |
| Device | Real Time Nucleic Acid Amplification System |
| Product Code | OOI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALERE SCARBOROUGH, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 2 |
Human-Device Interface Problem | 1 |
False Positive Result | 1 |
Fire | 1 |
Device Displays Incorrect Message | 1 |
| Total Device Problems | 6 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Bd Diagnostic | II | Apr-04-2017 |
| 2 | Becton Dickinson & Co. | II | Jun-18-2015 |
| 3 | Luminex Corporation | II | May-16-2017 |
| 4 | Roche Molecular Systems, Inc. | II | Feb-26-2014 |