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# Class 2 Designation for Microbial Image Assessment Systems
- URL: https://www.fdaweb.com/class-2-designation-for-microbial-image-assessment-systems/
- Published: 2017-10-17T12:00:00.000Z
- Updated: 2026-09-14T22:56:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139885

*Federal Register* notice: FDA has classified automated image assessment systems for microbial colonies on solid culture media into Class 2 (special controls). The action is the result of a 12/2015 *de novo* petition from Clever Culture Systems AG for its APAS Compact. The agency has named the generic type of device “automated image assessment system for microbial colonies on solid culture media,” and it is identified as a system that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, and phenotypic and morphologic characteristics through analysis of two dimensional digital images as an aid in diagnosis of infectious disease. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-10-16/pdf/2017-22305.pdf?ref=fdaweb.com).