VITEK COMPACT PRO

The VITEK® COMPACT PRO is an automated laboratory instrument for antimicrobial susceptibility testing (AST) and microbial identification. It performs automated quantitative/qualitative AST of isolated bacterial colonies including aerobic Gram-negative bacilli, Staphylococcus, Enterococcus, Streptococcus species, and yeasts, as well as identification of anaerobic organisms, Corynebacterium species, and various Gram-positive and fastidious organisms.

The VITEK® COMPACT PRO uses the same VITEK® 2 AST and ID 64-well cards, same optical readers (660 nm for AST, 428/568/680 nm for ID), same vacuum fill process, automated heat sealing, and VITEK 2 System Software algorithms for analysis as the predicate. Key differences include lower card capacity (15 cards vs. 60-120 for predicate), manual-only AST dilution preparation (vs. manual and auto), and a two-step automated design for sample preparation, incubation, and optical reading.

Not stated in this summary.

The VITEK® COMPACT PRO is substantially equivalent because it uses identical reagent cards, optical wavelengths, sealing processes, and VITEK 2 System Software algorithms as the predicate VITEK® 2 System. Clinical performance testing demonstrated very high agreement with predicate results: 98.8% essential agreement and 97.3% categorical agreement for GN cards, 99.5% EA/97.4% CA for GP cards, 98.5% EA/98.7% CA for ST cards, and 100% for YS cards. Quality control testing showed >99% pass rates, and reproducibility exceeded 95% across all test card classes, establishing that the device performs identically to the predicate despite its smaller capacity and different workflow.