Arton One-Step HCG Urinary Pregnancy Test (Strip, Cassette, Midstream)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K060019 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 rapid, qualitative immunochromatographic in vitro assay for the detection of human chorionic gonadotropin (hCG) in urine. It is classified as a pregnancy test kit designed for both professional and self-testing use, providing a visual result to aid in early pregnancy diagnosis.
The Arton One-Step HCG Urinary Pregnancy Test is supplied in three formats: strip, cassette, and midstream, each including one test device and a package insert. It is intended for over-the-counter use and has received FDA 510(k) clearance under the Traditional pathway, with a clearance number of K060019. The device is non-sterile and single-use, with no MRI safety considerations specified.
Frequently asked questions
What formats are available for the Arton One-Step HCG Urinary Pregnancy Test, and how are they different from each other?
The Arton One-Step HCG Urinary Pregnancy Test is available in three formats: strip, cassette, and midstream. All formats use the same rapid, qualitative immunochromatographic method to detect human chorionic gonadotropin (hCG) in urine, providing a visual result for early pregnancy diagnosis. The primary difference lies in the design and ease of use—strip tests are typically inserted directly into urine, cassettes offer a more enclosed testing area, and midstream tests are designed to be held under a steady urine stream for convenience.
Is the Arton One-Step HCG Urinary Pregnancy Test intended for professional use only, or can it be used for self-testing at home?
The Arton One-Step HCG Urinary Pregnancy Test is explicitly designed for both professional and self-testing use. It is classified as an over-the-counter device, meaning it is intended for use by individuals without requiring medical supervision. The visual result format makes it accessible for home testing while still being suitable for clinical settings.
How should the Arton One-Step HCG Urinary Pregnancy Test be stored, and is it reusable?
The Arton One-Step HCG Urinary Pregnancy Test is non-sterile and intended for single-use only. Storage instructions are included in the package insert, but generally, such tests should be kept in a cool, dry place away from direct sunlight and extreme temperatures. Reusing the device is not recommended, as it could compromise accuracy and introduce contamination risks.
What regulatory pathway was used for FDA clearance of this device, and what does that mean for its intended use?
The Arton One-Step HCG Urinary Pregnancy Test received FDA clearance under the Traditional 510(k) pathway, specifically determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against an existing, legally marketed pregnancy test and found it to have the same intended use and technological characteristics. The clearance confirms its safety and effectiveness for detecting hCG in urine to aid in early pregnancy diagnosis, as described in the device’s labeling.
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: Arton One-step Hcg Urinary Pregnancy Test (Strip), (Cassette ..., HCG Test Kit - Artron Laboratories Inc, www.accessdata.fda.gov, Artron-Laboratories FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K060019 | Class II | Active |
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Manufacturer
- Manufacturer
- Artron Laboratories Inc.
- FDA Applicant
- Artron Laboratories, Inc.
Sources (1)
- FDA 510(k) K060019 24 fields · synced Sep 18, 2026