| Device Type ID | 292 |
| Device Name | Glucose Oxidase, Glucose |
| Regulation Description | Glucose 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 | 862.1345 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | CGA |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 292 |
| Device | Glucose Oxidase, Glucose |
| Product Code | CGA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glucose Test System. |
| CFR Regulation Number | 862.1345 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
APEX BIOTECHNOLOGY CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARKRAY, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EOSHEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
NOVA | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
NOVA BIOMEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
POLYMER TECHNOLOGY SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SENDX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 91 |
Low Test Results | 57 |
Incorrect Or Inadequate Test Results | 37 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 33 |
Electrical /Electronic Property Problem | 18 |
Failure To Power Up | 9 |
Test Strip | 8 |
Image Display Error / Artifact | 7 |
Overheating Of Device | 5 |
Computer Software Problem | 5 |
High Readings | 5 |
Smoking | 3 |
Battery | 3 |
Device Operates Differently Than Expected | 3 |
Output Problem | 3 |
Device Emits Odor | 3 |
Loss Of Power | 2 |
Peeled / Delaminated | 2 |
Display | 2 |
Noise, Audible | 2 |
Unable To Obtain Readings | 2 |
Thermal Decomposition Of Device | 2 |
Image Resolution Poor | 2 |
Defective Component | 2 |
Device Displays Incorrect Message | 2 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Circuit Failure | 2 |
Capacitor | 1 |
Non Reproducible Results | 1 |
Use Of Device Problem | 1 |
No Display / Image | 1 |
Melted | 1 |
Low Readings | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Material Discolored | 1 |
Device Operational Issue | 1 |
PC (Printed Circuit) Board | 1 |
Changes In Ambient Temperature In Device Environment | 1 |
False Positive Result | 1 |
Housing | 1 |
Device Damaged Prior To Use | 1 |
Display Or Visual Feedback Problem | 1 |
Mechanical Problem | 1 |
No Device Output | 1 |
Insufficient Information | 1 |
Sticking | 1 |
Analyzer | 1 |
Material Fragmentation | 1 |
Off-Label Use | 1 |
Out-Of-Box Failure | 1 |
Device Handling Problem | 1 |
| Total Device Problems | 336 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arkray Factory USA, Inc. | I | Jan-15-2016 |
| 2 | DIABETIC SUPPLY OF SUNCOAST, INC. | I | Jul-22-2014 |
| 3 | ELITech Clinical Systems SAS | II | Nov-05-2015 |
| 4 | JAS Diagnostics Inc. | II | Jun-25-2014 |
| 5 | Nova Biomedical Corporation | II | Jan-09-2014 |
| 6 | Ortho-Clinical Diagnostics | II | Oct-17-2016 |
| 7 | Osmetech Inc | II | Jun-25-2015 |
| 8 | Radiometer America Inc | II | Dec-24-2014 |
| 9 | Roche Diagnostics Operations, Inc. | II | Feb-02-2015 |
| 10 | Siemens Healthcare Diagnostics, Inc | II | Jul-02-2015 |
| 11 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |
| 12 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |