Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregn…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K150022 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)
This device is a qualitative in vitro diagnostic test for detecting human chorionic gonadotropin (HCG) in urine, used to confirm pregnancy. The Wondfo One Step HCG Urine Pregnancy Test operates as a lateral flow immunoassay, providing a visual result indicating the presence or absence of HCG within minutes. It is classified as a kit, test, pregnancy, HCG, over-the-counter diagnostic device under regulatory frameworks.
The tests are supplied as single-use, non-sterile devices intended for home or clinical use. They are designed for one-time use and require no special storage conditions beyond protection from extreme temperatures and moisture. The Strip, Cassette, and Midstream formats accommodate different sample collection methods, including direct urine application or midstream collection. Authorised under FDA 510(k) clearance and In Vitro Diagnostic Device Directive (IVDD), these tests comply with regulatory standards for diagnostic accuracy and safety.
Frequently asked questions
What types of sample collection methods are supported by the Wondfo One Step HCG Urine Pregnancy Test, and how do they differ?
The Wondfo One Step HCG Urine Pregnancy Test is available in three formats: Strip, Cassette, and Midstream. The Strip and Cassette formats allow for direct urine application, where you dip the test into a urine sample or apply urine directly to the test. The Midstream format, however, is designed for midstream collection, where urine flows directly from the stream onto the test without needing to collect urine in a container first. This provides flexibility depending on user preference and convenience.
Are these pregnancy tests single-use only, and if so, what does that mean for storage and handling?
Yes, these tests are explicitly designed for single-use only. This means each test strip, cassette, or midstream device can only be used once and must be discarded after a single test. Since they are non-sterile, proper storage is essential to maintain their integrity. They should be kept protected from extreme temperatures and moisture, but no special storage conditions beyond this are required. Always ensure the packaging remains intact until use.
How quickly can I expect to see results after using the Wondfo One Step HCG Urine Pregnancy Test?
The Wondfo One Step HCG Urine Pregnancy Test is a lateral flow immunoassay designed to provide a visual result within minutes of use. While the exact time may vary slightly depending on the format (Strip, Cassette, or Midstream), results are typically available in under 5 minutes, allowing for quick confirmation of pregnancy status.
What regulatory pathways have these pregnancy tests undergone, and what does that mean for their reliability?
The Wondfo One Step HCG Urine Pregnancy Test has undergone regulatory review through the FDA’s 510(k) clearance process, specifically classified as substantially equivalent under the Clinical Chemistry advisory committee. It also complies with the In Vitro Diagnostic Device Directive (IVDD). These pathways ensure the tests meet established standards for diagnostic accuracy and safety, providing confidence in their reliability for detecting human chorionic gonadotropin (HCG) in urine.
Can these tests be used in both clinical and home settings, and are there any special considerations for each?
Yes, the Wondfo One Step HCG Urine Pregnancy Test is intended for use in both clinical and home settings. While the design is straightforward for home use—such as self-testing with minimal training—they are also suitable for clinical environments where quick, reliable results are needed. In both settings, the tests require no special handling beyond following the provided instructions for sample application (direct urine or midstream). Since they are non-sterile, clinical use may involve additional infection control measures.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K150022 | Class II | Active |
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Manufacturer
- Manufacturer
- Guangzhou Wondfo Biotech Co., Ltd.
Sources (2)
- FDA 510(k) K150022 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026