The FDA has granted 510(k) clearance to La Vista, Neb.-based Streck’s MDx-Chex control kit for verifying the performance of the company’s BioFire BCID2 assay panel for sepsis.

The control kit contains 43 bacteria, yeasts and antimicrobial resistance gene targets packaged in two separate vials, one for Gram-negative bacteria and the other for Gram-positive bacteria and yeasts.

The inactivated microorganisms are suspended in a matrix of stabilized red blood cells, white blood cells and blood culture media components, which is designed to challenge the assay like a patient sample, the La Vista, Neb.-based company explained.