DEVICE: BIOMIC (00863504000217)

An in vitro diagnostic software program intended to be used for the interpretation of results of an in vitro diagnostic assay [e.g., minimum inhibitory concentration (MIC), mass spectrometry (MALDI-TOF)] performed on a microbial culture isolated from a clinical specimen, to determine the susceptibility, intermediate or resistance categorization of the microbial species. It is installed on an off-the-shelf computer or a web-based platform, and compares assay results (e.g., an acquired image, mass spectrum) to reference data to determine antimicrobial resistance (e.g., beta-lactamase, carbapenamase, and/or cephalosporinase activity). Results are used to guide patient treatment options.

A mains electricity (AC-powered) automated or semi-automated laboratory device designed to count bacterial colonies in a culture. It typically consists of a sample container (e.g., Petri dish, pour or spiral plate, culture flask), appropriate light sources, a camera and/or microscope, a display, and dedicated software. The device may be used to count microorganisms in different colony configurations – separating, highlighting, and making computerized counts of the colonies. It may also perform zone measuring (e.g., for antibacterial susceptibility tests) and/or additional tests that may include particle counting, such as cell tests for mutagenicity (i.e., Ames tests).