| Device |
prescription use blood glucose meter for near-patient testing |
| Regulation Description |
Glucose test system. |
| Definition |
Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining dysglycemia. |
| Physical State |
The device is comprised of glucose test strips and a meter that measures and displays the result. |
| Technical Method |
The user obtains a blood sample and applies it to a test strip that contains an enzyme that reacts with the glucose on the test strip. The test strip is inserted in the meter, which measures the amount of glucose in the blood sample. |
| Target Area |
Whole blood |
| Regulation Medical Specialty |
Clinical Chemistry |
| Review Panel |
Clinical Chemistry |
|---|
| Product Code | PZI |
|---|
| Premarket Review |
Office of In Vitro Diagnostics
(OHT7)
Division of Chemistry and Toxicology Devices
(DCTD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
862.1345
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
