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Hospital Continuous Glucose Monitoring System

Page Type
Product Code
Definition
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
Physical State
The device system is comprised of a cartridge and an instrument that measures and displays the result.
Technical Method
The operator connects the device to the blood source of the patient and activates the assay.
Target Area
Whole blood.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1345
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1345 Glucose test system

§ 862.1345 Glucose test system.

(a) 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.

(b) 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]

Hospital Continuous Glucose Monitoring System

Page Type
Product Code
Definition
Intended for the continuous, quantitative measurement of glucose in whole blood in a hospital setting.
Physical State
The device system is comprised of a cartridge and an instrument that measures and displays the result.
Technical Method
The operator connects the device to the blood source of the patient and activates the assay.
Target Area
Whole blood.
Regulation Medical Specialty
Chemistry
Review Panel
Chemistry
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
862.1345
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 862.1345 Glucose test system

§ 862.1345 Glucose test system.

(a) 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.

(b) 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.

[52 FR 16122, May 1, 1987, as amended at 84 FR 71796, Dec. 30, 2019; 85 FR 18445, Apr. 2, 2020]