21 CFR 862.1345 — Hexokinase, Glucose
Clinical Chemistry (CH) · Part 862 Subpart B—Clinical Chemistry Test Systems · § 862.1345
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.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| CFR | Hexokinase, Glucose | 2 | 145 | 3rd Party |
| CFW | Copper Reduction, Glucose | 2 | 0 | 3rd Party |
| CGA | Glucose Oxidase, Glucose | 2 | 400 | 3rd Party |
| CGD | Ferricyanide, Glucose | 2 | 0 | 3rd Party |
| CGE | Orthotoluidine, Glucose | 2 | 12 | 3rd Party |
| LFR | Glucose Dehydrogenase, Glucose | 2 | 73 | 3rd Party |
| MRV | Drink, Glucose Tolerance | 2 | 3 | |
| NBW | System, Test, Blood Glucose, Over The Counter | 2 | 508 | |
| PYV | Hospital Continuous Glucose Monitoring System | 2 | 0 | |
| PZI | Prescription Use Blood Glucose Meter For Near-Patient Testing | 2 | 13 |
Special Controls
CFR — Hexokinase, Glucose
*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.
eCFR
CFW — Copper Reduction, Glucose
*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.
eCFR
CGA — Glucose Oxidase, Glucose
*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.
eCFR
CGD — Ferricyanide, Glucose
*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.
eCFR
CGE — Orthotoluidine, Glucose
*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.
eCFR
LFR — Glucose Dehydrogenase, Glucose
*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.
eCFR
MRV — Drink, Glucose Tolerance
*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.
eCFR
NBW — System, Test, Blood Glucose, Over The Counter
*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.
eCFR
PYV — Hospital Continuous Glucose Monitoring System
*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.
eCFR
PZI — Prescription Use Blood Glucose Meter For Near-Patient Testing
*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.
eCFR
