| Device Type ID | 607 |
| Device Name | Glucose Dehydrogenase, 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 | LFR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 607 |
| Device | Glucose Dehydrogenase, Glucose |
| Product Code | LFR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Glucose Test System. |
| CFR Regulation Number | 862.1345 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ABOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CERAGEM MEDISYS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EPS BIO TECHNOLOGY CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ROCHE DIAGNOSTICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 2961 |
Test Strip | 1287 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 360 |
High Test Results | 257 |
Low Test Results | 229 |
Non Reproducible Results | 32 |
Failure To Power Up | 15 |
Improper Device Output | 9 |
Output Problem | 7 |
Unexpected Therapeutic Results | 5 |
Device Operates Differently Than Expected | 4 |
High Readings | 4 |
Device Displays Incorrect Message | 3 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Image Display Error / Artifact | 3 |
Unintended Movement | 2 |
Monitor | 2 |
Tube | 2 |
Shelf Life Exceeded | 2 |
Use Of Device Problem | 2 |
Improper Or Incorrect Procedure Or Method | 2 |
Defective Component | 1 |
Low Readings | 1 |
Issue With Displayed Error Message | 1 |
Material Twisted / Bent | 1 |
False Reading From Device Non-Compliance | 1 |
Incorrect Software Programming Calculations | 1 |
Appropriate Term/Code Not Available | 1 |
No Display / Image | 1 |
Retraction Problem | 1 |
Misfire | 1 |
Gauges/Meters | 1 |
Inaccurate Delivery | 1 |
Defective Device | 1 |
Thermal Decomposition Of Device | 1 |
Moisture Damage | 1 |
Unable To Obtain Readings | 1 |
Pump | 1 |
Loss Of Power | 1 |
Off-Label Use | 1 |
Physical Resistance / Sticking | 1 |
Leak / Splash | 1 |
| Total Device Problems | 5212 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Roche Diabetes Care, Inc. | II | May-09-2018 |
| 2 | Roche Diagnostics Operations, Inc. | II | Mar-14-2016 |