Beta-Tec
by Wampole Laboratories 510(k)
Active
510(k) K781794
Overview
The Beta-Tec is a visual pregnancy human chorionic gonadotropin (hCG) test device designed for prescription use. It is classified as a Class II medical device under FDA regulations and falls under the Clinical Chemistry advisory committee category. The device is intended for qualitative detection of hCG in urine, aiding in the confirmation of pregnancy.
Beta-Tec is supplied as a single-use diagnostic test and requires no special storage conditions beyond those recommended by the manufacturer. It is not intended for MRI use and is regulated under the FDA’s 510(k) clearance process, with the specific clearance number K781794. The device was granted Substantially Equivalent status in 1978 and is governed by regulation number 862.1155. No information regarding reusability or sterility beyond standard single-use diagnostic testing is provided.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781794 | Date29 Dec 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Wampole Laboratories
Questions
What is the Beta-Tec device used for?
The Beta-Tec is a visual pregnancy test designed for qualitative detection of human chorionic gonadotropin (hCG) in urine. It aids in confirming pregnancy by providing a clear visual result, typically used in clinical settings where prescription testing is required.
Is the Beta-Tec device single-use or reusable?
The Beta-Tec is explicitly supplied as a single-use diagnostic test. This design ensures accuracy and hygiene, as reuse could compromise reliability and introduce contamination risks.
What storage conditions are required for the Beta-Tec?
No special storage conditions are required beyond those recommended by the manufacturer. Standard storage practices for medical devices—such as protection from extreme temperatures, moisture, and direct sunlight—should be followed to maintain its integrity.
Is the Beta-Tec sterile?
The Beta-Tec is intended for single-use diagnostic testing, which inherently assumes sterility for the purpose of its intended use. However, specific sterility claims beyond standard single-use diagnostic testing protocols are not detailed in the provided data.
What regulatory pathway does the Beta-Tec follow?
The Beta-Tec was granted Substantially Equivalent (SE) status under the FDA’s 510(k) clearance process, specifically under clearance number K781794. It falls under the Clinical Chemistry advisory committee category and is classified as a Class II medical device, governed by regulation number 862.1155.