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Shinetell PlusTM Digital Early Pregnancy Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K251053

by Hangzhou AllTest Biotech Co., Ltd.

Identifiers

510(k) Number
K251053 FDA 510(k)
FDA Product Code
LCX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1155 FDA 510(k)
Regulation Number
862.1155 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Shinetell Plus Digital Early Pregnancy Test is a digital pregnancy test kit designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It employs a lateral flow immunoassay combined with light reflection technology to provide a digital result, distinguishing it from traditional visual strip tests. The device is classified as a Class II medical device under FDA regulations and is intended for over-the-counter use.

This test is supplied as a single-use, non-sterile device for home or clinical use. It operates by detecting hCG levels via a built-in LED light source and digital display, eliminating the need for manual interpretation. The device is regulated under FDA 510(k) clearance (K251053) and falls under the Clinical Chemistry specialty category. No MRI safety or reusable components are specified, and storage conditions are not detailed in the regulatory data.

Frequently asked questions

What is the Shinetell Plus Digital Early Pregnancy Test used for?

The Shinetell Plus Digital Early Pregnancy Test is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It provides a digital result through a lateral flow immunoassay combined with light reflection technology, distinguishing it from traditional visual strip tests. This makes it useful for confirming early pregnancy at home or in clinical settings.

How is the Shinetell Plus Digital Early Pregnancy Test supplied?

The Shinetell Plus Digital Early Pregnancy Test is supplied as a single-use, non-sterile device. Each unit is intended for one-time use only, ensuring hygiene and accuracy for individual testing sessions.

Is the Shinetell Plus Digital Early Pregnancy Test reusable?

No, the Shinetell Plus Digital Early Pregnancy Test is explicitly designed for single-use only. This design ensures reliability and prevents cross-contamination between tests.

What distinguishes the Shinetell Plus Digital Early Pregnancy Test from traditional pregnancy tests?

Unlike traditional visual strip tests, the Shinetell Plus Digital Early Pregnancy Test uses a built-in LED light source and digital display to provide a clear, unambiguous result. This eliminates the need for manual interpretation of faint lines, reducing user error and improving accuracy.

What regulatory approval does the Shinetell Plus Digital Early Pregnancy Test hold?

The Shinetell Plus Digital Early Pregnancy Test holds FDA 510(k) clearance under the classification of a Class II medical device. It is intended for over-the-counter use and falls under the Clinical Chemistry specialty category, ensuring it meets stringent regulatory standards for diagnostic accuracy and safety.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Shinetell PlusTM Digital Early Pregnancy Test (K251053) — FDA 510 (k ..., PDF Hangzhou AllTest Biotech Co., Ltd. ℅ Jenny Xia Director LSI ..., Shinetell PlusTM Digital Early Pregnancy Test — FDA K251053, K251053 FDA 510 (k) - Shinetell PlusTM Digital Early Pregnanc...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Hangzhou AllTest Biotech Co., Ltd.

Sources (1)

  • FDA 510(k) K251053 24 fields · synced Oct 1, 2026