Definition: A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.
| Device Type ID | 3553 |
| Device Name | Gram-positive Bacteria And Their Resistance Markers |
| Physical State | Blood |
| Technical Method | Multiplexed DNA Hybridization Array |
| Target Area | Systemic |
| 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 | PAM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3553 |
| Device | Gram-positive Bacteria And Their Resistance Markers |
| Product Code | PAM |
| 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 | |
GREAT BASIN SCIENTIFIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICUBATE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Positive Result | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | BioFire Diagnostics, Inc. | II | Jun-20-2014 |
| 2 | BioFire Diagnostics, LLC | II | Oct-30-2018 |
| 3 | Great Basin Scientific, Inc. | II | Jan-19-2017 |
| 4 | Luminex Corporation | III | Feb-11-2019 |
| 5 | Luminex Corporation | II | Nov-10-2018 |
| 6 | Nanosphere, Inc. | II | Sep-30-2014 |
| 7 | Nanosphere, Inc. | II | Sep-23-2014 |