cobas® liat CT/NG/MG nucleic acid test

The cobas liat CT/NG/MG nucleic acid test is an automated, qualitative in vitro diagnostic test that uses real-time PCR to directly detect Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium nucleic acids in male urine and vaginal swab specimens. It is intended as an aid in diagnosing urogenital infections in both symptomatic and asymptomatic individuals.

The device uses automated sample preparation, real-time PCR amplification technology, and fluorescence detection via paired reporter and quencher probes (TaqMan technology with FRET). It includes an internal control and yields results through PCR cycle threshold analysis. These core technical features match the predicate devices (cobas 6800/8800 CT/NG and TV/MG), though the submitted device operates on the cobas liat analyzer platform rather than the cobas 6800/8800 system.

Not stated in this summary.

The device demonstrates substantial equivalence through: (1) identical intended use for the same three pathogens and specimen types; (2) matching technological characteristics including automated sample prep, real-time PCR, TaqMan detection chemistry, and cycle threshold analysis; (3) non-clinical performance showing adequate analytical sensitivity (LoD), inclusivity across multiple strains/serovars, analytical specificity with minimal cross-reactivity, and reproducibility across sites and operators with >90% agreement; and (4) clinical performance with sensitivity/specificity of 97–100% for CT/NG and 95–97% for MG, comparable to predicate device performance standards, demonstrating the assay reliably detects the target organisms without increased false positives or false negatives.