BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

The BIOFIRE Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test that simultaneously identifies 43 bacterial and yeast species and detects antimicrobial resistance genes directly from positive blood culture samples in about one hour. Results are intended to aid diagnosis of bloodstream infections and should be interpreted alongside Gram stain results and other clinical findings.

The device uses a highly-multiplexed nested nucleic acid amplification test with melt curve analysis, performed on the BIOFIRE FILMARRAY 2.0 or FILMARRAY TORCH systems. The test employs two-stage PCR with automated sample processing, magnetic bead-based nucleic acid extraction, and software-controlled melt curve interpretation. The modification involved updating the pouch module software to adjust melting temperature (Tm) ranges for organism detection assays to incorporate synthetic control material data.

Not stated in this summary.

The software update adjusts Tm ranges for specific assays (particularly C. tropicalis) to mitigate false negative results identified during control testing, but does not alter the fundamental scientific technology, overall performance claims, or intended use of the panel. The reanalysis of clinical and analytical performance data with the revised software resulted only in a minor adjustment to S. epidermidis sensitivity (96.5% to 96.9%) and did not change overall study conclusions. Since the device operates identically to the predicate in terms of specimen type, instrumentation, technological principles, time to result, organism detection capability, and antimicrobial resistance gene detection, the software refinement constitutes a performance improvement without altering substantial equivalence.