HCG One Step Pregnancy Test Strip
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233624 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 Pregnancy Test Kit designed to detect human chorionic gonadotropin (hCG) in urine, indicating pregnancy. It operates as a rapid, qualitative diagnostic tool, providing visual results through a colorimetric reaction on a test strip or midstream collection device.
The HCG One Step Pregnancy Test is supplied as a single-use, non-sterile diagnostic device intended for home or clinical use. Available in both strip and midstream formats, it requires no special storage conditions and is classified under In Vitro Diagnostic Device Directive (IVDD) and FDA 510(k) clearance. Results are interpreted visually without additional equipment.
Frequently asked questions
What types of pregnancy tests does this manufacturer offer, and how do they differ in usage?
This manufacturer provides two formats for their HCG One Step Pregnancy Test: strip and midstream. The strip version requires dipping the test into urine collected in a container, while the midstream version allows urine to flow directly onto the test for convenience. Both formats detect human chorionic gonadotropin (hCG) in urine to indicate pregnancy through a visual color change, but the midstream design eliminates the need for a collection cup.
Are these pregnancy tests reusable, and if not, what should I do with them after use?
These tests are single-use only and should not be reused. After use, dispose of them according to local waste disposal guidelines for medical devices. Since they are non-sterile and designed for one-time diagnostic use, reuse could compromise accuracy and hygiene.
Do these tests require special storage conditions, and how should they be handled before use?
No special storage conditions are required. The tests can be stored at room temperature and do not need refrigeration. However, ensure they remain in a dry place, protected from direct sunlight or extreme temperatures, to maintain their integrity until use. Always check the expiration date before testing.
What regulatory pathways have these pregnancy tests undergone, and how does that affect their use?
These tests have undergone FDA 510(k) clearance and comply with the In Vitro Diagnostic Device Directive (IVDD). The clearance indicates they are deemed substantially equivalent to a predicate device, ensuring their safety and performance meet regulatory standards. Clinicians and users can rely on their accuracy for qualitative pregnancy detection, though adherence to the manufacturer’s instructions is critical for valid results.
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: Human Chorionic Gonadotropin (hCG): Purpose & Levels
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 | K233624 | Class II | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
Sources (2)
- FDA 510(k) K233624 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 18, 2026