Product Classification

• Device: microbial colony image assessment system
• 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 Code: PPU
• Premarket Review: Division of Microbiology Devices (DMD); 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

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• beanstock ventures
• global quality and regulatory services
• regulatory technology services, llc
• sgs north america