Automated Image Assessment System

The Automated Image Assessment System for Microbial Colonies on Solid Culture Media is an in vitro diagnostic device that automates the screening and analysis of microbial growth on solid culture media using digital imaging technology and advanced software, improving efficiency, accuracy, and reducing manual intervention in microbiology laboratories.

Intended Use of Automated Image Assessment System for Microbial Colonies on Solid Culture Media

 An Automated Image Assessment System for Microbial Colonies on Solid Culture Media is 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.

Intended Use:

Culture plate imaging system for qualitative assessment of resistant organisms is an automated system to assess the presence or absence of colony growth on solid chromogenic culture media.

Device Description:

It is an in vitro diagnostic device designed to automate the initial screening of culture plates in microbiology laboratories. The system consists of an automated plate handling mechanism, an imaging station, and software for analyzing and reporting growth. The device operates by analyzing and interpreting digital images of colonies on solid chromogenic culture media, enabling efficient identification and assessment of growth. The physical state of the device includes an imaging system and analysis software for accurate evaluation of culture plate results.

Microbial Colony Image Assessment System

Intended Use:

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, when using its urine analysis module, must be reviewed by a trained microbiologist.

Device Description:

It is an in vitro diagnostic device for automating the screening and semi-quantitative assessment of growth on urine culture plates in microbiology laboratories. It features an automated plate handling system, an imaging station, and software for growth analysis and reporting. The device detects growth presence and provides a semi-quantitative colony count, aiding in urinary tract infection screening. It improves microbiologist efficiency by focusing attention on plates with significant growth, reducing result reporting time. This module screens urine specimens plated on Blood and MacConkey agars, incubated for 18 to 22 hours at 35±2°C. The Physical State involves using solid microbiological culture media for assessment, while the Technical Method entails analyzing and interpreting digital images of microbial cultures grown on solid media.

• Precision (Reproducibility and Repeatability)
• Accuracy (Trueness, Precision)
• Analytical Sensitivity and Specificity
• Digital Quality Image Study
• Software Verification and Validation Testing
• Human factor/ Usability validation
• Electrical safety
• Mechanical safety
• Chemical safety
• Thermal safety
• Radiation safety

Clinical Testing:

 No Guidance available for 510k submission