| Device Type ID | 614 |
| Device Name | Immunoassay Method, Troponin Subunit |
| Regulation Description | Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1215 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MMI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 614 |
| Device | Immunoassay Method, Troponin Subunit |
| Product Code | MMI |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Creatine Phosphokinase/creatine Kinase Or Isoenzymes Test System. |
| CFR Regulation Number | 862.1215 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 888 |
False Positive Result | 368 |
Adverse Event Without Identified Device Or Use Problem | 215 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 188 |
False Negative Result | 157 |
Low Test Results | 151 |
Mechanical Problem | 111 |
Incorrect Or Inadequate Test Results | 102 |
No Apparent Adverse Event | 39 |
Test Strip | 33 |
Device Operates Differently Than Expected | 32 |
Tube | 24 |
Probe | 20 |
Insufficient Information | 15 |
Cell | 15 |
Non Reproducible Results | 9 |
Device Displays Incorrect Message | 8 |
Mixer | 7 |
Failure To Obtain Sample | 7 |
Device Issue | 7 |
High Readings | 5 |
Device Ingredient Or Reagent | 4 |
Device Operational Issue | 3 |
Device Handling Problem | 3 |
Misassembly By Users | 2 |
Missing Value Reason | 2 |
False Reading From Device Non-Compliance | 2 |
Photomultiplier (PM) Tube | 2 |
Washer | 2 |
Low Readings | 2 |
Valve | 2 |
Syringe | 2 |
Electrical /Electronic Property Problem | 2 |
Seal | 2 |
Reservoir | 1 |
Use Of Device Problem | 1 |
Appropriate Term/Code Not Available | 1 |
Inadequate Service | 1 |
Fail-Safe Problem | 1 |
Holder | 1 |
False Alarm | 1 |
Clumping In Device Or Device Ingredient | 1 |
Nozzle | 1 |
Cable | 1 |
Device Component Or Accessory | 1 |
Filter | 1 |
Calibration Problem | 1 |
Photomultiplier | 1 |
Imprecision | 1 |
Unable To Obtain Readings | 1 |
Air Leak | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Leak / Splash | 1 |
| Total Device Problems | 2450 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics Inc | II | Jan-07-2016 |
| 2 | Siemens Healthcare Diagnostics, Inc | II | Jun-21-2016 |
| 3 | Siemens Healthcare Diagnostics, Inc | II | Jul-23-2015 |
| 4 | Siemens Healthcare Diagnostics, Inc | II | Jul-02-2014 |
| 5 | Siemens Healthcare Diagnostics, Inc. | II | Jul-13-2018 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |
| 7 | Siemens Healthcare Diagnostics, Inc. | II | May-05-2017 |
| 8 | Siemens Healthcare Diagnostics, Inc. | II | Jun-25-2015 |
| 9 | Siemens Healthcare Diagnostics, Inc. | II | Dec-12-2014 |
| 10 | Tosoh Bioscience Inc | II | Jun-05-2018 |