Atellica IM Total PSA II (tPSAII)

The Atellica IM total PSA II (tPSAII) is an in vitro diagnostic assay that quantitatively measures prostate-specific antigen (PSA) in human serum and plasma samples using the Atellica IM Analyzer. It is indicated as an aid in detecting prostate cancer in men aged 50 and older (alongside digital rectal exam) and for monitoring patients with prostate cancer, though prostate biopsy is required for definitive diagnosis.

The device uses chemiluminescence with a sandwich immunoassay operating principle on the Atellica IM platform. Key differences from the predicate include: use of monoclonal mouse anti-free-PSA and anti-PSA antibodies (versus polyclonal goat antibody), biotin-streptavidin paramagnetic particle coupling (versus direct covalent coupling), acceptance of both serum and plasma samples (versus serum only), smaller sample volume (30 µL versus 35 µL), and a measuring interval of 0.009–50.000 ng/mL (versus 0.04–100.00 ng/mL).

Not stated in this summary.

Substantial equivalence is based on identical instrument, measurement principle, and technology (chemiluminescence sandwich immunoassay). Performance characteristics testing—including precision, reproducibility, interference, cross-reactivity, matrix comparison, and traceability—demonstrated equivalent behavior. Clinical studies in 88 prostate cancer patients showed 91.8% positive percent agreement and 96.7% negative percent agreement between the new assay and a comparative assay, supporting equivalence for the intended use in disease monitoring.