| Device Type ID | 3432 |
| Device Name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Regulation Description | Fully Automated Short-term Incubation Cycle Antimicrobial Susceptibility System. |
| 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 | 866.1645 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LON |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 3432 |
| Device | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Product Code | LON |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Fully Automated Short-term Incubation Cycle Antimicrobial Susceptibility System. |
| CFR Regulation Number | 866.1645 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BD | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BECTON, DICKINSON & CO. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BECTON, DICKINSON AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BECTON, DICKINSON, AND COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOMERIEUX | ||
SUBSTANTIALLY EQUIVALENT | 17 | |
BIOMERIEUX, INC. | ||
SUBSTANTIALLY EQUIVALENT | 10 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 630 |
Incorrect Or Inadequate Test Results | 202 |
False Positive Result | 23 |
False Negative Result | 6 |
Low Test Results | 4 |
Device Operates Differently Than Expected | 4 |
Data Back-Up Problem | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Smoking | 3 |
Therapeutic Or Diagnostic Output Failure | 3 |
Failure To Back-Up | 3 |
Device Damaged Prior To Use | 3 |
Failure To Obtain Sample | 2 |
Patient Data Problem | 2 |
Fire | 2 |
Missing Test Results | 2 |
Product Quality Problem | 2 |
Device Inoperable | 1 |
Battery Problem | 1 |
Communication Or Transmission Problem | 1 |
Device Operational Issue | 1 |
Use Of Device Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Device Displays Incorrect Message | 1 |
Device Issue | 1 |
Device Packaging Compromised | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Computer Software Problem | 1 |
Difficult To Insert | 1 |
Unable To Obtain Readings | 1 |
| Total Device Problems | 910 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Co. | II | Feb-23-2019 |
| 2 | Becton Dickinson & Co. | II | Nov-25-2017 |
| 3 | Becton Dickinson & Co. | III | Oct-25-2016 |
| 4 | BioMerieux SA | II | Jun-12-2018 |
| 5 | Biomerieux Inc | II | Aug-25-2017 |
| 6 | Biomerieux Inc | II | May-22-2017 |
| 7 | Biomerieux Inc | II | May-03-2016 |
| 8 | Organon Teknika Inc | II | Feb-27-2019 |
| 9 | Siemens Healthcare Diagnostics, Inc. | I | Nov-07-2014 |
| 10 | bioMerieux, Inc. | II | Feb-16-2019 |
| 11 | bioMerieux, Inc. | II | Dec-19-2018 |
| 12 | bioMerieux, Inc. | II | Dec-17-2018 |
| 13 | bioMerieux, Inc. | I | Aug-30-2018 |