| Device Type ID | 306 |
| Device Name | Alkaline Picrate, Colorimetry, 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 | CGX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 306 |
| Device | Alkaline Picrate, Colorimetry, Creatinine |
| Product Code | CGX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Creatinine Test System. |
| CFR Regulation Number | 862.1225 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SIEMENS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 66 |
Low Test Results | 24 |
Incorrect Or Inadequate Test Results | 17 |
Adverse Event Without Identified Device Or Use Problem | 17 |
Tube | 9 |
Probe | 8 |
Mechanical Problem | 7 |
Human Factors Issue | 6 |
Insufficient Information | 4 |
Washer | 3 |
Lamp | 2 |
Pump | 2 |
False Negative Result | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Cooling Module | 1 |
Leak / Splash | 1 |
Temperature Problem | 1 |
Needle | 1 |
Nozzle Tip | 1 |
Non Reproducible Results | 1 |
Mixer | 1 |
Suction Problem | 1 |
Device Ingredient Or Reagent | 1 |
Valve | 1 |
Nozzle | 1 |
| Total Device Problems | 178 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Horiba Instruments Inc | II | Feb-02-2016 |
| 2 | Pointe Scientific, Inc. | III | Sep-16-2015 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | Jun-26-2015 |
| 4 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |