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U.S. Department of Health and Human Services

Product Classification
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Device microbial colony image assessment system
Regulation Description Automated image assessment system for microbial colonies on solid culture media.
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.
Physical State Solid microbiological culture media are required to conduct the assessment.
Technical Method Analysis and interpretation of digital images of microbial cultures on solid media.
Target Area Not applicable
Regulation Medical Specialty Microbiology
Review Panel Microbiology
Product CodePPU
Premarket Review Office of In Vitro Diagnostics (OHT7)
Division of Microbiology Devices (DMD)
Submission Type 510(k)
Regulation Number 866.2190
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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