| Device Type ID | 2362 |
| Device Name | System, Multipurpose For In Vitro Coagulation Studies |
| Regulation Description | Multipurpose System For In Vitro Coagulation Studies. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5425 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JPA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 2362 |
| Device | System, Multipurpose For In Vitro Coagulation Studies |
| Product Code | JPA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Multipurpose System For In Vitro Coagulation Studies. |
| CFR Regulation Number | 864.5425 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CORAMED TECHNOLOGIES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAEMONETICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HAEMONETICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEKISUI MEDICAL CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
| Device Problems | |
|---|---|
High Test Results | 53 |
Low Test Results | 26 |
Incorrect Or Inadequate Test Results | 15 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 13 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Overheating Of Device | 6 |
Insufficient Information | 3 |
Thermal Decomposition Of Device | 3 |
Computer Software Problem | 2 |
Device Maintenance Issue | 2 |
Inadequate Or Insufficient Training | 2 |
Device Handling Problem | 2 |
Inadequate Instructions For Healthcare Professional | 2 |
Data Problem | 2 |
Misconnection | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Low Readings | 1 |
False Reading From Device Non-Compliance | 1 |
Fire | 1 |
Incorrect Measurement | 1 |
Use Of Device Problem | 1 |
Maintenance Does Not Comply To Manufacturers Recommendations | 1 |
Non Reproducible Results | 1 |
Off-Label Use | 1 |
Installation-Related Problem | 1 |
Electrical Shorting | 1 |
Unintended Movement | 1 |
Erratic Or Intermittent Display | 1 |
Output Problem | 1 |
Charred | 1 |
No Device Output | 1 |
| Total Device Problems | 160 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Accriva Diagnostics Inc., Dba ITC, Dba Accumetrics | II | May-25-2016 |
| 2 | Haemonetics Corporation | II | Feb-19-2015 |
| 3 | ITC-Nexus Dx | II | Jul-21-2014 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Feb-19-2016 |
| 5 | TEM Systems Inc | II | Oct-23-2016 |
| 6 | TEM Systems Inc | II | Apr-03-2015 |