| Device Type ID | 289 |
| Device Name | Hexokinase, 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 | CFR |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
|
| Device Type ID | 289 |
| Device | Hexokinase, Glucose |
| Product Code | CFR |
| 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 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BECKMAN COULTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ELITECHGROUP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Mechanical Problem | 37 |
Low Test Results | 30 |
Adverse Event Without Identified Device Or Use Problem | 18 |
High Test Results | 14 |
Incorrect Or Inadequate Test Results | 8 |
Probe | 4 |
Pump | 2 |
Valve | 2 |
Holder | 1 |
Device Component Or Accessory | 1 |
Washer | 1 |
Non Reproducible Results | 1 |
Screw | 1 |
Spring | 1 |
Contamination Of Device Ingredient Or Reagent | 1 |
Device Subassembly | 1 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
| Total Device Problems | 124 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Horiba Instruments Inc | II | Feb-02-2016 |
| 2 | JAS Diagnostics Inc. | II | Dec-18-2014 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |