MDx-Chex for BCY

MDx-Chex for BCY is an external quality control kit consisting of positive and negative assayed controls designed to monitor the performance of the Diasorin LIAISON PLEX Yeast Blood Culture assay on the LIAISON PLEX System. The controls contain stabilized erythrocytes and leukocytes in a blood culture media matrix and are composed to control for assay inhibitors including hemoglobin, leukocyte DNA, and anticoagulants.

The device is a ready-to-use liquid control material with the same physical format and composition as the predicate device (MDx-Chex for BCID2). It monitors 14 yeast targets through the same assay steps (lysis, nucleic acid isolation/purification, amplification, detection, and identification). The key difference is that MDx-Chex for BCY is specific to yeast detection only, whereas the predicate monitors yeast, Gram-positive bacteria, Gram-negative bacteria, and antimicrobial resistance genes (>30 targets).

Not stated in this summary.

Substantial equivalence is established through demonstrating that MDx-Chex for BCY shares the same intended use category (external quality control for blood culture assays), physical format (ready-to-use liquid), composition (buffered solution with stabilized blood components), and assay monitoring approach as the predicate device MDx-Chex for BCID2 (K212576). Comprehensive performance testing including multi-site reproducibility, repeatability, lot-to-lot precision, stability, and shipping studies all achieved ≥90% agreement with expected results, demonstrating safety and effectiveness equivalent to the predicate.