Definition: A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.
| Device Type ID | 3558 |
| Device Name | Gram-negative Bacteria And Associated Resistance Markers |
| Physical State | Reagent Kit |
| Technical Method | Multiplexed Nucleic Acid-based Assay |
| Target Area | N/A |
| Regulation Description | Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures. |
| 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 | 866.3365 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PEN |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3558 |
| Device | Gram-negative Bacteria And Associated Resistance Markers |
| Product Code | PEN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multiplex Nucleic Acid Assay For Identification Of Microorganisms And Resistance Markers From Positive Blood Cultures. |
| CFR Regulation Number | 866.3365 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NANOSPHERE, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioFire Diagnostics, LLC | II | Apr-25-2018 |
| 2 | Nanosphere, Inc. | II | Sep-30-2014 |
| 3 | Nanosphere, Inc. | II | Sep-23-2014 |
| 4 | Nanosphere, Inc. | II | Aug-14-2014 |
| 5 | Nanosphere, Inc. | II | Aug-08-2014 |