Definition: Instrumentation For Clinical Multiplex Test Systems Is A Device That Is Intended To Measure And Sort Multiple Signals Generated By An Assay From A Clinical Sample. The Generated Signals From Multiple Probes Or Other Ligands May Be Measured By Fluores
| Device Type ID | 639 |
| Device Name | Instrumentation For Clinical Multiplex Test Systems |
| 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 | NSU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 639 |
| Device | Instrumentation For Clinical Multiplex Test Systems |
| Product Code | NSU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Instrumentation For Clinical Multiplex Test Systems. |
| CFR Regulation Number | 862.2570 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOARRAY SOLUTIONS, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BIOMERIEUX SA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
Bio-Rad Laboratories | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LABOROATORY CORPORATION OF AMERICA HOLDINGS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LUMINEX MOLECULAR DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 15 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 6 |
Data Problem | 4 |
Device Displays Incorrect Message | 4 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device Stops Intermittently | 2 |
Incorrect Or Inadequate Test Results | 2 |
Overheating Of Device | 2 |
Thermal Decomposition Of Device | 2 |
Disconnection | 1 |
Output Problem | 1 |
Insufficient Information | 1 |
Device Emits Odor | 1 |
Loss Of Data | 1 |
Device Sensing Problem | 1 |
Improper Device Output | 1 |
Contamination During Use | 1 |
Material Discolored | 1 |
Connection Problem | 1 |
| Total Device Problems | 49 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Becton Dickinson & Co. | II | Jan-19-2018 |
| 2 | Hologic, Inc | II | Feb-12-2018 |
| 3 | Hologic, Inc | II | Oct-18-2017 |