Atlas One Step hCG Urine Pregnancy Test (Strip, Cassette, Midstream)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203246 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 Atlas One Step hCG Urine Pregnancy Test is a rapid immunochromatographic in vitro diagnostic device designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It functions as a pregnancy test kit, providing a visual result to indicate the presence or absence of hCG, a hormone produced during pregnancy.
This device is intended for self-testing and is supplied as single-use strips, cassettes, or midstream collection formats. It is classified as a Class II medical device under FDA regulations and has received FDA 510(k) clearance and IVDD authorization. The tests are non-sterile, non-reusable, and do not require MRI safety considerations. Sensitivity is specified at 25 mIU/mL.
Frequently asked questions
What are the three formats available for the Atlas One Step hCG Urine Pregnancy Test, and how do they differ in use?
The Atlas One Step hCG Urine Pregnancy Test is available in three formats: strip, cassette, and midstream. The strip format requires dipping the test into urine collected in a container, while the cassette format uses a dropper to place urine on a designated area of the test. The midstream format allows urine to flow directly onto the test without prior collection, making it convenient for self-testing at home.
Is the Atlas One Step hCG Urine Pregnancy Test reusable, and what is its sterility status?
No, the Atlas One Step hCG Urine Pregnancy Test is not reusable—each test is designed for single-use only. Additionally, the device is non-sterile, meaning it is not intended for use in sterile medical procedures or environments.
What is the sensitivity of the Atlas One Step hCG Urine Pregnancy Test, and how soon after conception might it detect pregnancy?
The test has a sensitivity of 25 mIU/mL, meaning it can detect human chorionic gonadotropin (hCG) at this concentration in urine. Since hCG levels typically rise rapidly after conception, the test may detect pregnancy as early as the first day of a missed menstrual cycle, though results vary based on individual hormone levels.
How should the Atlas One Step hCG Urine Pregnancy Test be stored, and are there any special handling requirements?
The test should be stored in a cool, dry place (typically 2°C–30°C / 36°F–86°F) and protected from direct sunlight or extreme humidity. No special handling is required beyond following the included instructions for use, as it is non-sterile and intended for home testing.
What regulatory pathways has the Atlas One Step hCG Urine Pregnancy Test undergone, and which advisory committee was involved?
The device has received FDA 510(k) clearance and In Vitro Diagnostic Device (IVDD) authorization, confirming it meets U.S. regulatory standards for Class II medical devices. The submission was reviewed by the Clinical Chemistry (CH) Advisory Committee, which evaluates diagnostic tests for chemistry-related applications.
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: Atlas Link Technology | Product | One Step hCG Urine Test, HCG - Atlas Medical, Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG ..., Atlas Link Technology | Product | One Step hCG Combo Test
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 | K203246 | Class II | Active |
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Manufacturer
- Manufacturer
- Atlas Link Technology Co., Ltd.
Sources (2)
- FDA 510(k) K203246 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026