Shinetell PlusTM Digital Early Pregnancy Test

The Shinetell Plus™ Digital Early Pregnancy Test is an over-the-counter device that qualitatively detects human chorionic gonadotropin (hCG) in urine to aid in early pregnancy detection, as early as 5-6 days before a missed period. It uses lateral flow immunoassay technology with a digital display screen to show results (Pregnant, Not Pregnant, or Invalid) within approximately 3 minutes.

The device differs from its predicate by featuring a digital/LCD screen readout instead of visual testing lines, achieving results in 3 minutes instead of 5 minutes, and using midstream-only format rather than strip, cassette, or midstream options. Both devices share identical sensitivity (10 mIU/mL), specimen type (urine), assay technique (immunochromatographic), and qualitative results for over-the-counter use.

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

Substantial equivalence is based on identical intended use, specimen type, assay principle, sensitivity, result type, and target user population compared to the predicate Wondfo test. Performance data demonstrates 100% conformity with the predicate device in method comparison studies (49/49 positive, 51/51 negative for dip; 48/48 positive, 52/52 negative for midstream). Lay-user studies showed 100% agreement with professional testing, and the device exhibits robust analytical performance including no cross-reactivity, no hook effect up to 500,000 mIU/mL, and tolerance to pH 4-9 and urine density variations. The only differences—digital readout, faster results, and midstream-only format—represent minor technological variations that do not affect the fundamental performance or safety profile.