MDx-Chex for BCN

MDx-Chex for BCN is a quality control kit containing two assayed controls (Level 1 and Level 2) designed to monitor the performance of the DiaSorin LIAISON PLEX Gram-Negative Blood Culture assay. The controls are composed of buffered solutions with stabilized erythrocytes and leukocytes in blood culture media, containing various gram-negative bacteria species and antimicrobial resistance genes for positive and negative control purposes.

MDx-Chex for BCN monitors 18 gram-negative bacteria organisms and 8 antimicrobial resistance genes, compared to the predicate device (MDx-Chex for BC-GN) which monitors 8 gram-negative organisms and 6 resistance genes. Both are ready-to-use liquids processed like patient samples, containing intact inactivated bacteria, human erythrocytes, leukocytes, and blood culture media components, with identical assay steps monitored (lysis, nucleic acid isolation/purification, DNA hybridization, detection, and reporting).

Not stated in this summary.

Substantial equivalence is established because MDx-Chex for BCN has the same intended use, physical format, composition, and assay methodology as the predicate device (K231223 MDx-Chex for BC-GN). Performance data demonstrate reproducibility across multiple sites and lots (≥90% agreement), repeatability (98-100% positive percent agreement), lot-to-lot consistency (100% agreement), and stability for 75 days at both refrigerated and room temperatures, with no negative matrix effects compared to clinical samples.