MRV · Drink, Glucose Tolerance
Clinical Chemistry · 21 CFR 862.1345 · Class 2
Overview
| Product Code | MRV |
|---|---|
| Device Name | Drink, Glucose Tolerance |
| Regulation | 21 CFR 862.1345 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
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.
Classification Rationale
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.
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.
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120247 | EASYDEX | Vineland Syrup, Inc. | Jun 21, 2012 | SESE |
| K042183 | GLUCOSE TOLERANCE BEVERAGE | Ever Scientific | Oct 27, 2004 | SESE |
| K032753 | GLUCOSE TOLERANCE BEVERAGE | Perk Scientific, Inc. | Nov 18, 2003 | SESE |
Top Applicants
- Vineland Syrup, Inc. — 1 clearance
- Perk Scientific, Inc. — 1 clearance
- Ever Scientific — 1 clearance
