| Device Type ID | 317 |
| Device Name | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Regulation Description | Blood Gases (PCO2, PO2) And Blood PH 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 | 862.1120 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CHL |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 317 |
| Device | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Product Code | CHL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Blood Gases (PCO2, PO2) And Blood PH Test System. |
| CFR Regulation Number | 862.1120 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EDAN INSTRUMENTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NOVA | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
NOVA BIOMEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
RADIOMETER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RADIOMETER MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 88 |
Low Test Results | 59 |
High Test Results | 51 |
Use Of Device Problem | 37 |
Incorrect Or Inadequate Test Results | 37 |
Non Reproducible Results | 23 |
False Positive Result | 15 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Patient Data Problem | 12 |
Fluid Leak | 10 |
Insufficient Information | 7 |
Computer Software Problem | 6 |
Device Handling Problem | 6 |
False Negative Result | 5 |
Device Issue | 4 |
Leak / Splash | 4 |
Data Problem | 4 |
Port | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Low Readings | 2 |
Connection Problem | 2 |
Electrical /Electronic Property Problem | 2 |
Output Problem | 2 |
Mechanical Problem | 2 |
Calibration Problem | 1 |
Sensor | 1 |
Calibration Error | 1 |
Image Display Error / Artifact | 1 |
Device Subassembly | 1 |
Use Of Incorrect Control Settings | 1 |
Coagulation In Device Or Device Ingredient | 1 |
High Readings | 1 |
Device Displays Incorrect Message | 1 |
Application Program Freezes, Becomes Nonfunctional | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Appropriate Term/Code Not Available | 1 |
Electrode | 1 |
Degraded | 1 |
Incorrect Measurement | 1 |
Improper Device Output | 1 |
Compatibility Problem | 1 |
Power Problem | 1 |
Device Contamination With Body Fluid | 1 |
Holder | 1 |
Product Quality Problem | 1 |
False Reading From Device Non-Compliance | 1 |
Computer System Security Problem | 1 |
Device Operates Differently Than Expected | 1 |
Device Component Or Accessory | 1 |
| Total Device Problems | 419 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Point Of Care Inc. | II | Dec-14-2018 |
| 2 | Abbott Point Of Care Inc. | II | Mar-27-2014 |
| 3 | LifeHealth, LLC | II | Oct-23-2015 |
| 4 | LifeHealth, LLC | II | Jun-27-2015 |
| 5 | Nova Biomedical Corporation | II | Jul-13-2017 |
| 6 | Radiometer America Inc | II | Feb-05-2019 |
| 7 | Radiometer America Inc | II | Dec-22-2018 |
| 8 | Radiometer America Inc | II | Dec-08-2017 |
| 9 | Radiometer America Inc | II | Mar-14-2017 |
| 10 | Radiometer America Inc | II | Dec-22-2016 |
| 11 | Radiometer America Inc | II | Feb-03-2016 |
| 12 | Radiometer America Inc | II | Jun-25-2015 |
| 13 | Radiometer America Inc | II | Feb-24-2014 |
| 14 | Radiometer America Inc | II | Jan-10-2014 |
| 15 | Radiometer Medical ApS | II | Mar-14-2018 |
| 16 | Roche Diagnostics Operations, Inc. | II | Jan-23-2017 |
| 17 | Roche Diagnostics Operations, Inc. | II | Aug-21-2015 |
| 18 | Roche Diagnostics Operations, Inc. | II | Aug-05-2015 |
| 19 | Roche Diagnostics Operations, Inc. | III | Oct-10-2014 |
| 20 | Siemens Healthcare Diagnostics Inc | II | May-05-2017 |
| 21 | Siemens Healthcare Diagnostics Inc | II | Sep-14-2016 |