| Device Type ID | 390 |
| Device Name | Enzymatic Method, Creatinine |
| Regulation Description | Creatinine 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 | 862.1225 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JFY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 390 |
| Device | Enzymatic Method, Creatinine |
| Product Code | JFY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Creatinine Test System. |
| CFR Regulation Number | 862.1225 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ACON LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELITECH GROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ORTHO-CLINICAL DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 36 |
Mechanical Problem | 24 |
High Test Results | 16 |
Low Test Results | 14 |
Insufficient Information | 11 |
Device Issue | 6 |
Device Ingredient Or Reagent | 5 |
Non Reproducible Results | 4 |
Incorrect Or Inadequate Test Results | 3 |
Washer | 1 |
Device Ingredient Or Reagent Problem | 1 |
| Total Device Problems | 121 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Ortho-Clinical Diagnostics | III | Sep-19-2018 |
| 3 | Ortho-Clinical Diagnostics | II | Apr-23-2014 |
| 4 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 5 | Sentinel CH SPA | II | Jun-27-2017 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |
| 7 | Siemens Healthcare Diagnostics, Inc. | II | Sep-05-2015 |