FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream

FaStep Early Pregnancy Rapid Test is an over-the-counter immunochromatographic assay for qualitative detection of human chorionic gonadotropin (hCG) in urine. The device is available in three formats (strip, cassette, and midstream) and is intended as an aid in early detection of pregnancy, with capability to detect pregnancy as early as six days before a missed period.

The candidate device uses lateral flow immunoassay with mouse monoclonal anti-β-hCG antibody colloidal gold conjugate on the sample pad and anti-α-hCG antibody on the test line. It has a sensitivity of 10 mIU/mL, qualitative results, and a read time of 3-10 minutes. The predicate device also has 10 mIU/mL sensitivity but requires a 5-minute read time. The candidate is labeled for over-the-counter use only, whereas the predicate allows both prescription and OTC use.

The device is calibrated against WHO International Standard 5th edition (NIBSC code 07/364). The document does not cite specific ISO, IEC, or ASTM consensus standards.

Substantial equivalence is established through identical intended use (early pregnancy detection via urine hCG), specimen type (urine), assay methodology (immunochromatographic), sensitivity (10 mIU/mL), qualitative results, and device formats (strip, cassette, midstream). Performance testing demonstrates 100% concordance with the predicate device across 321 clinical samples, 100% agreement between lay users and professionals, and no false positives in 900 non-pregnant samples across all age groups. Analytical specificity was confirmed with 30+ interferent substances and cross-reactants at clinically relevant concentrations. The minor differences in read time (3-10 vs 5 minutes) and user population (OTC-only vs prescription+OTC) do not affect the fundamental safety and effectiveness profile.