| Device Type ID | 313 |
| Device Name | Enzymatic Esterase--oxidase, Cholesterol |
| Regulation Description | Cholesterol (total) 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 | 862.1175 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | CHH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 313 |
| Device | Enzymatic Esterase--oxidase, Cholesterol |
| Product Code | CHH |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cholesterol (total) Test System. |
| CFR Regulation Number | 862.1175 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACON LABORATORIES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACON LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ALERE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
POLYMER TECHNOLOGY SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 8 |
Low Test Results | 7 |
Adverse Event Without Identified Device Or Use Problem | 5 |
Test Strip | 4 |
Probe | 3 |
Mechanical Problem | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Valve | 1 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 32 |
| 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 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |
| 7 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |