iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip

The iHealth® Early Pregnancy Test is an over-the-counter in vitro diagnostic device that detects human chorionic gonadotropin (hCG) in urine to aid in early detection of pregnancy. The device is available in two formats—stick and strip—and can detect pregnancy as early as five to six days before a missed period, with results displayed as two lines for pregnant or one line for not pregnant within 3–5 minutes.

The subject device uses a lateral flow sandwich immunochromatographic assay with gold conjugate and visual result display, identical to the predicate. Key differences include: (1) two device formats (strip and stick) versus one; (2) traceability to WHO 5th International Standard for hCG versus WHO 4th Standard; and (3) the ability to recognize both intact hCG and hCG β-subunit, whereas the predicate detects only intact hCG and uses a scavenger system to remove it in the presence of FSH.

Not stated in this summary.

Substantial equivalence is supported by: (1) identical test principle, sample matrix (urine), target analyte (hCG), sensitivity (10 mIU/mL), read time (3–5 minutes), and visual control mechanism; (2) 100% conformity with the predicate device in both method comparison (204 subjects, 109 positive and 95 negative samples) and lay user studies; (3) demonstrated clinical performance detecting pregnancy from day −9 to day 0 relative to missed period; and (4) comprehensive analytical validation showing no hook effect up to 1,000,000 mIU/mL, no cross-reactivity, no interference from 19 tested substances, and stability for 24 months. The two-format design and enhanced hCG analyte detection do not alter the fundamental intended use or safety/effectiveness profile.