---
kind: "section"
citation: "21 C.F.R. § 862.1345"
title: "21"
number: "862.1345"
heading: "Glucose test system."
url: "https://uscodex.org/cfr/21/862.1345"
---

# §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](/cfr/21/part807-subpartE.md) of this chapter subject to the limitations in [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

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

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 16122, May 1, 1987, unless otherwise noted.

### Amendments

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