Acro HCG Pregnancy Rapid Test
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180771 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 Acro HCG Pregnancy Rapid Test is a qualitative urine immunoassay designed for the detection of human chorionic gonadotropin (hCG). It functions as a rapid diagnostic test to aid in the early confirmation of pregnancy by identifying hCG levels in a urine sample. This device falls under the category of in vitro diagnostic kits, specifically for pregnancy testing, and operates via a lateral flow immunoassay mechanism.
This test is intended for over-the-counter (OTC) self-use and is supplied as a single-use cassette. It requires no specialized equipment or sterile preparation beyond standard urine collection procedures. The test is not reusable and does not require regulatory approval beyond its FDA 510(k) clearance under the Clinical Chemistry advisory committee. It is classified as a Class II device and adheres to regulatory standards for diagnostic accuracy and labeling compliance.
Frequently asked questions
What is the Acro HCG Pregnancy Rapid Test used for?
The Acro HCG Pregnancy Rapid Test is a qualitative urine immunoassay designed to detect human chorionic gonadotropin (hCG) in urine samples. It aids in the early confirmation of pregnancy by identifying hCG levels, which are produced during pregnancy. This test is intended for over-the-counter self-use and provides results quickly via a lateral flow mechanism.
How is the Acro HCG Pregnancy Rapid Test supplied and used?
The test is supplied as a single-use cassette, meaning each cassette is intended for one-time use only. No specialized equipment or sterile preparation is required beyond standard urine collection procedures. Simply follow the instructions on the package to collect a urine sample, apply it to the test cassette, and read the results within the specified timeframe.
Is the Acro HCG Pregnancy Rapid Test sterile and reusable?
No, the Acro HCG Pregnancy Rapid Test is not sterile beyond standard urine collection procedures, as it is designed for single-use only. Each cassette is intended for one test and should not be reused. Reusing the test could compromise accuracy and introduce contamination risks.
What regulatory approval does the Acro HCG Pregnancy Rapid Test have?
The Acro HCG Pregnancy Rapid Test holds FDA 510(k) clearance under the Clinical Chemistry advisory committee. This clearance confirms that the device is substantially equivalent to a legally marketed predicate device and meets regulatory standards for diagnostic accuracy and labeling compliance. It is classified as a Class II medical device.
How should the Acro HCG Pregnancy Rapid Test be stored?
While the device data does not specify storage conditions explicitly, most rapid pregnancy tests like this should be stored in a cool, dry place away from direct sunlight and extreme temperatures. Always refer to the packaging instructions for precise storage guidelines to ensure the test remains effective until use.
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: Women's Health | Acro Biotech, Inc., Digital Early Pregnancy Test - acrobiotech.com, PDF ACON *hCG - Frilabo, Acro Biotech Pregnancy Test Overview
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180771 | Class II | Active |
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Manufacturer
- Manufacturer
- Acro Biotech Inc
- FDA Applicant
- Acro Biotech, Inc.
Sources (1)
- FDA 510(k) K180771 24 fields · synced Oct 1, 2026