Shinetell Digital Pregnancy Test

K241978 · Hangzhou AllTest Biotech Co., Ltd. · LCX · Aug 13, 2024 · Clinical Chemistry

Device Facts

• Record ID: K241978
• Device Name: Shinetell Digital Pregnancy Test
• Applicant: Hangzhou AllTest Biotech Co., Ltd.
• Product Code: LCX · Clinical Chemistry
• Decision Date: Aug 13, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1155
• Device Class: Class 2

Indications for Use

Shinetell™ Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.

Device Story

Shinetell™ Digital Pregnancy Test is a lateral flow immunoassay for qualitative hCG detection in human urine. The device consists of a test strip in a plastic housing with an absorbent tip, used in either dip or midstream mode. Operation involves applying urine to the tip; an internal LED light source and photodiode detect light reflection changes caused by the formation of a colloidal gold-antibody-hCG complex on the test strip. The device processes these light intensity signals to determine if hCG levels exceed a 25 mIU/mL threshold. Results are displayed on an integrated LCD screen as 'Pregnant', 'Not Pregnant', or '?' (invalid). Designed for home use, the device provides immediate visual feedback to the user, facilitating early pregnancy identification without requiring professional interpretation.

Clinical Evidence

Bench testing only. Analytical performance demonstrated 25 mIU/mL sensitivity, no hook effect up to 500,000 mIU/mL, and no interference from common substances or urine variables (pH/density). Method comparison with the predicate device showed 100% conformity across 200 samples. A lay-person study (n=200) confirmed 100% positive and negative agreement with professional testing, and a secondary study (n=200) confirmed 100% accuracy at 5 mIU/mL and 25 mIU/mL concentrations.

Technological Characteristics

Lateral flow immunoassay using anti-beta-HCG antibody-colloidal gold conjugate. Detection via LED light source and photodiode reflection measurement. Dimensions: 152.4 x 24 x 16.5 mm. Standalone device with integrated LCD display. Calibrated against WHO International Standard 5th edition (NIBSC 07/364).

Indications for Use

Indicated for qualitative detection of hCG in human urine to aid in early pregnancy detection. For over-the-counter use by individuals seeking pregnancy status.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K241978

This 510(k) was reviewed under the OHT7/OHT8 OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.