Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream

The Synthgene Home Test HCG Test is an over-the-counter immunochromatographic assay for qualitative detection of human chorionic gonadotropin (HCG) in urine to aid early detection of pregnancy. The device is offered in three formats: strip, cassette, and midstream, each containing a ready-to-use test component, urine cup, medical waste bag, and instructions for use.

The candidate device uses a double antibody sandwich immunochromatographic assay with colloidal gold-labeled antibodies on a nitrocellulose membrane. Sensitivity is 25 mIU/mL with qualitative results (positive/negative). The primary difference from the predicate is reading time: candidate requires 5–20 minutes versus predicate's 5 minutes. All other characteristics—specimen type (urine), assay methodology, sensitivity, results format, intended user (over-the-counter), and device formats—are identical to the predicate.

Not stated in this summary.

Substantial equivalence is established through: (1) identical intended use, specimen type, assay methodology, and sensitivity (25 mIU/mL) as the predicate; (2) comprehensive analytical testing demonstrating 100% accuracy at clinically relevant HCG concentrations with no interference from 31 endogenous and exogenous substances, pH variations (4–9), or specific gravity changes (1.000–1.035); (3) method comparison studies on 333 clinical samples across all three formats showing 100% concordance with predicate results; (4) lay-user studies confirming ease of use and correct result interpretation; and (5) no hook effect observed up to 1,860,000 mIU/mL. The longer reading window is a minor, non-safety-critical difference that does not affect clinical performance or safety profile.