bioMerieux, Inc. · Class II · Cleared Apr 15, 2026
| K-number | K260282 |
| Device name | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance |
| Applicant | bioMerieux, Inc. |
| Product code | LON |
| Device class | Class II |
| Decision date | Apr 15, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 866.1645 |
The VITEK® 2 AST-Streptococcus Inducible Clindamycin Resistance is an automated antimicrobial susceptibility test card designed to determine in vitro resistance of Streptococcus species (including S. pneumoniae and beta-hemolytic groups) to clindamycin and erythromycin. It is used with VITEK® 2 Systems in clinical laboratories as a qualitative test to guide antimicrobial therapy decisions.
The device uses a miniaturized microdilution card with 64 wells containing premeasured antibiotic concentrations (clindamycin 0.5 μg/mL and clindamycin/erythromycin 0.25/0.5 μg/mL). It operates with the VITEK® 2, VITEK® 2 Compact, and VITEK® Compact PRO instruments using discriminant analysis algorithms to generate positive/negative breakpoint results. The only differences from the predicate are the antimicrobial agent concentrations and test card type, plus expanded instrument compatibility.
CLSI (Clinical and Laboratory Standards Institute) breakpoints were used for performance evaluation. The device was compared to D-test reference method (disk diffusion screen test with clindamycin and erythromycin disks) using clinical and challenge isolates.
View the full FDA submission: accessdata.fda.gov