| Device Type ID | 403 |
| Device Name | Electrode, Ion Specific, Sodium |
| Regulation Description | Sodium 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 | 862.1665 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JGS |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 403 |
| Device | Electrode, Ion Specific, Sodium |
| Product Code | JGS |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sodium Test System. |
| CFR Regulation Number | 862.1665 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
AWARENESS TECHNOLOGY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NOVA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NOVA BIOMEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS OPERATIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 355 |
Mechanical Problem | 59 |
High Test Results | 57 |
Low Test Results | 56 |
Adverse Event Without Identified Device Or Use Problem | 26 |
Electrode | 25 |
Incorrect Or Inadequate Test Results | 19 |
False Positive Result | 10 |
Nozzle | 8 |
Probe | 8 |
Tube | 7 |
Insufficient Information | 5 |
Washer | 5 |
Non Reproducible Results | 4 |
False Negative Result | 4 |
Device Issue | 4 |
Valve | 3 |
PC (Printed Circuit) Board | 2 |
Mixer | 2 |
Reservoir | 1 |
Cable | 1 |
Device Contamination With Body Fluid | 1 |
Low Readings | 1 |
Mechanism | 1 |
Electrical Lead | 1 |
Human Factors Issue | 1 |
Device Subassembly | 1 |
Missing Value Reason | 1 |
Housing | 1 |
| Total Device Problems | 669 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ortho-Clinical Diagnostics | II | Mar-09-2019 |
| 2 | Ortho-Clinical Diagnostics | II | Sep-28-2018 |
| 3 | Ortho-Clinical Diagnostics | II | Jan-31-2017 |
| 4 | Ortho-Clinical Diagnostics | II | Feb-25-2014 |
| 5 | Radiometer America Inc | II | Jan-23-2014 |
| 6 | Siemens Healthcare Diagnostics, Inc. | II | May-01-2018 |
| 7 | Siemens Healthcare Diagnostics, Inc. | II | Oct-30-2015 |
| 8 | Siemens Healthcare Diagnostics, Inc. | II | Apr-07-2015 |