MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

The MissLan® Early Detection Digital Pregnancy Test and MissLan® Early Result Digital Pregnancy Test are over-the-counter digital pregnancy tests that qualitatively detect human chorionic gonadotropin (hCG) in urine to aid in early pregnancy detection, potentially as early as five days before the expected menstrual period. Both devices use battery power and display results on an LCD screen, with one showing graphic symbols (+, -, or invalid) and the other displaying text (Pregnant, Not Pregnant, or Error).

The candidate devices are battery-powered midstream tests with LCD digital displays and a sensitivity of 10 mIU/mL hCG, compared to the predicate device which offers non-powered formats (strip, cassette, midstream) with visual line-based result interpretation. Both use the same lateral flow immunoassay methodology and specimen type (urine) with identical analyte (hCG), sensitivity, and qualitative results.

Not stated in this summary.

Substantial equivalence is supported by identical test principles (lateral flow immunoassay), same analyte (hCG), specimen type (urine), sensitivity (10 mIU/mL), and qualitative results. Method comparison studies show 100% conformity between the candidate and predicate devices across 400 clinical samples. Lay-user studies demonstrate that untrained users achieve 100% agreement with professional testing results. Early pregnancy detection studies show the device achieves 78.46% detection rate at five days before expected period and 100% by the expected period date. Specificity studies on 600 non-pregnant women across all age groups showed zero false positives. The primary differences—digital display format and battery power—do not alter the fundamental immunoassay performance or clinical utility.