Revogene

The Revogene is a PCR instrument for in vitro diagnostic use that automates sample lysis, dilution, nucleic acid amplification, and detection of target sequences using fluorescence-based real-time PCR in clinical laboratories. It processes up to 8 samples per run using assay-specific cartridges (PIEs) and provides automated result interpretation.

The modified Revogene adds a photomultiplier tube (PMT) cooling system to reduce fluorescence glitches and prevent instrument blocking, upgrades the operating system from Windows 7 Embedded Standard to Windows 10 IoT Enterprise, and updates system software for Windows 10 compatibility. The predicate device lacks the PMT cooling system and runs Windows 7.

Not stated in this summary.

Substantial equivalence is based on identical intended use, sample preparation method, mode of operation (real-time PCR with fluorogenic detection), automatic assay capability, sample identification, internal process controls, and instrument specifications including 4 optical channels and 8-specimen processing capacity. The PMT cooling system and OS/software upgrades are technological refinements that do not alter fundamental characteristics: testing showed no statistically significant differences in positivity/negativity rates, unresolved/indeterminate results, or mean Ct values between modified and predicate devices across representative assays, with the cooling system merely reducing glitch occurrence.