---
kind: "section"
citation: "21 C.F.R. § 862.1405"
title: "21"
number: "862.1405"
heading: "Immunoreactive insulin test system."
url: "https://uscodex.org/cfr/21/862.1405"
---

# §862.1405. Immunoreactive insulin test system.

- (a) **Identification.** An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.
- (b) **Classification.** Class I (general controls). The device is exempt from the premarket notification procedures in [subpart E of part 807](/cfr/21/part807-subpartE.md) of this chapter subject to [§ 862.9](/cfr/21/862.9.md).

## Notes

### Amendments

[52 FR 16122, May 1, 1987, as amended at 65 FR 2306, Jan. 14, 2000]

### 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 65 FR 2306, Jan. 14, 2000]