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 |