FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette

The FaStep Pregnancy Rapid Test Cassette and Fastep HCG Rapid Test Cassette are immunochromatographic devices that qualitatively detect Human Chorionic Gonadotropin (HCG) in human urine to aid in early pregnancy detection. The first is intended for over-the-counter use, while the second is for healthcare professional use in physician office labs.

Both devices use lateral flow immunoassay with mouse monoclonal anti-β-hCG antibody colloidal gold conjugate on the sample pad and immobilized anti-α-hCG and anti-mouse IgG antibodies on a nitrocellulose membrane. They demonstrate 20 mIU/mL sensitivity, qualitative results displayed as two lines (positive) or one line (negative), cassette format, and 3-10 minute read time. The predicate device supports both urine and serum specimens with a 5-minute read time.

The device is calibrated against reference material traceable to WHO International Standard 5th edition (NIBSC code 07/364). No other consensus standards (ISO, IEC, ASTM) are cited in this summary.

Substantial equivalence is established through identical intended use (qualitative hCG detection for pregnancy screening), same assay principle (immunochromatographic), matching sensitivity (20 mIU/mL), identical specimen type (urine), same device format (cassette), and same result type (qualitative). Method comparison showed 100% conformity between candidate and predicate across 112 clinical samples. Performance testing demonstrated reproducibility, no interfering substance effects at tested concentrations, no cross-reactivity, and 100% agreement between lay users and professionals, establishing functional equivalence despite minor differences in read time and target user population.