PPU · Class II — Moderate Risk (510(k) clearance required) · Microbiology · 21 CFR 866.2190
Classification
FDA Product Code
PPU
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 866.2190
Review panel
MI
Medical specialty
Microbiology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
Y
Definition
A microbial colony image assessment system is an instrument that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics. This device type provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.