MissLan Early Detection Digital Pregnancy Test; MissLan Early Result Digital Pregnancy Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K251040 FDA 510(k)
- FDA Product Code
- LCX FDA 510(k)
- Models / Variants
- MissLan® Early Result Digital Pregnancy Test 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 MissLan Early Detection Digital Pregnancy Test and MissLan Early Result Digital Pregnancy Test are digital home-use devices designed to detect human chorionic gonadotropin (hCG) in urine. These tests provide visual results indicating pregnancy status, with the Early Detection model using symbols (+, -, or an open book icon) and the Early Result model displaying text (Pregnant, Not Pregnant, or Error).
These devices are intended for single-use and are classified as Class II medical devices under FDA regulation 862.1155. They are supplied as over-the-counter kits and require no special storage conditions. The MissLan tests received FDA 510(k) clearance (K251040) under the Traditional 510(k) Review pathway, classified as substantially equivalent to the predicate device. No third-party review was required.
Frequently asked questions
What is the MissLan Digital Pregnancy Test used for?
The MissLan Digital Pregnancy Test is designed to detect human chorionic gonadotropin (hCG) in urine, indicating pregnancy status. The Early Detection model shows results with symbols (+, -, or an open book icon), while the Early Result model displays text (Pregnant, Not Pregnant, or Error). This helps users determine pregnancy early and accurately at home.
How is the MissLan Digital Pregnancy Test supplied, and what are its storage requirements?
The MissLan Digital Pregnancy Test is supplied as a single-use, over-the-counter kit. No special storage conditions are required, meaning it can be stored at room temperature until use. Always follow the manufacturer’s instructions for optimal performance.
Are the MissLan Digital Pregnancy Tests reusable, or are they intended for single-use?
The MissLan Digital Pregnancy Tests are explicitly designed for single-use only. Each test is meant to be used once and then discarded. Reusing the device may compromise accuracy and reliability, so adherence to single-use guidelines is essential.
What distinguishes the Early Detection model from the Early Result model?
The key difference lies in how results are displayed: the Early Detection model uses symbols (+, -, or an open book icon) to indicate pregnancy status, while the Early Result model provides text-based results (Pregnant, Not Pregnant, or Error). Both models detect hCG in urine but present results in different formats for user convenience.
What regulatory pathway was followed for FDA clearance of the MissLan Digital Pregnancy Test?
The MissLan Digital Pregnancy Test received FDA 510(k) clearance under the Traditional 510(k) Review pathway, classified as substantially equivalent to a predicate device. This means it was evaluated by the FDA as meeting the same performance standards as an existing, cleared device. No third-party review was required for this submission.
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: MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result ..., MissLan® Early Detection Digital Pregnancy Test… - FDA.report, MissLan® Early Detection Digital Pregna... (K251040) - FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K251040 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Decheng Biotechnology Co., Ltd.
Sources (1)
- FDA 510(k) K251040 24 fields · synced Oct 1, 2026