MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET
Device Facts
| Record ID | K002199 |
|---|---|
| Device Name | MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET |
| Applicant | Pointe Scientific, Inc., |
| Product Code | CFR · Clinical Chemistry |
| Decision Date | Nov 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
Special Controls
*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
