---
kind: "section"
citation: "21 C.F.R. § 866.1645"
title: "21"
number: "866.1645"
heading: "Fully automated short-term incubation cycle antimicrobial susceptibility system."
url: "https://uscodex.org/cfr/21/866.1645"
---

# §866.1645. Fully automated short-term incubation cycle antimicrobial susceptibility system.

- (a) **Identification.** A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
- (b) **Classification.** Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry and FDA.”

## Notes

### Amendments

[68 FR 5827, Feb. 5, 2003]

### Authority

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

### Source

Source: 47 FR 50823, Nov. 9, 1982, unless otherwise noted.

### Amendments

[68 FR 5827, Feb. 5, 2003]