| Device Type ID | 255 |
| Device Name | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Regulation Description | Triglyceride 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) Exempt |
| CFR Regulation Number | 862.1705 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CDT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 255 |
| Device | Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides |
| Product Code | CDT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Triglyceride Test System. |
| CFR Regulation Number | 862.1705 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
RANDOX LABORATORIES, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Ingredient Or Reagent Problem | 12 |
Low Test Results | 5 |
Non Reproducible Results | 3 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Incorrect Or Inadequate Test Results | 2 |
High Test Results | 1 |
| Total Device Problems | 25 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Beckman Coulter Inc. | II | Jun-08-2016 |
| 3 | Beckman Coulter Inc. | II | Jan-28-2015 |
| 4 | Horiba Instruments Inc | II | Feb-02-2016 |
| 5 | Ortho-Clinical Diagnostics | II | Oct-17-2016 |
| 6 | Ortho-Clinical Diagnostics | II | Dec-22-2014 |
| 7 | Randox Laboratories Ltd. | II | May-04-2018 |
| 8 | Randox Laboratories Ltd. | II | Oct-18-2016 |
| 9 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 10 | Siemens Healthcare Diagnostics, Inc. | II | May-14-2016 |
| 11 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |