Unistep HCG Pregnancy Test Strip
by Biotech Atlantic, Inc. 510(k)
Active
510(k) K941090
Overview
The Unistep HCG Pregnancy Test Strip is a System, Test, Human Chorionic Gonadotropin (HCG) designed for the qualitative detection of human chorionic gonadotropin (HCG) in urine. It functions as a visual diagnostic tool, providing a simple, rapid result through color comparison to determine pregnancy status. This device falls under the Clinical Chemistry specialty and is classified as a waived complexity test, meaning it can be performed outside of regulated laboratory settings.
The test strip is supplied as a single-use, non-sterile device intended for home or point-of-care use. It requires no special storage conditions but should be protected from moisture and extreme temperatures. Authorized under FDA 510(k) clearance (K941090), this device adheres to regulatory standards for Class II medical devices under the Human Chorionic Gonadotropin Test System (DHA product code). No MRI safety considerations apply, as the strip is non-electronic and non-metallic.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941090 | Date2 Jun 1994 | 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- Withdrawn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
- DHA
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Biotech Atlantic, Inc.
Questions
What is the Unistep HCG Pregnancy Test Strip used for?
The Unistep HCG Pregnancy Test Strip is designed for the qualitative detection of human chorionic gonadotropin (hCG) in urine. It provides a visual result by comparing color changes to determine pregnancy status. This test is intended for use in home or point-of-care settings, such as clinics, where immediate results are needed.
Is the Unistep HCG Pregnancy Test Strip sterile?
No, the Unistep HCG Pregnancy Test Strip is supplied as a non-sterile device. It is intended for single-use only and does not require sterile conditions for use, making it suitable for home testing or point-of-care environments where full sterilization is impractical.
How should the Unistep HCG Pregnancy Test Strip be stored?
The test strip does not require special storage conditions but must be protected from moisture and extreme temperatures. Keeping it in a dry, sealed package and away from direct sunlight or heat sources will help maintain its accuracy and usability.
Is the Unistep HCG Pregnancy Test Strip reusable?
No, the Unistep HCG Pregnancy Test Strip is designed for single-use only. Each strip is intended to be used once and then discarded. Reusing the strip could compromise its accuracy and reliability.
What regulatory approval does the Unistep HCG Pregnancy Test Strip have?
The Unistep HCG Pregnancy Test Strip is authorized under FDA 510(k) clearance with the clearance number K941090. It is classified as a waived complexity test, meaning it can be performed outside of regulated laboratory settings, such as at home or in point-of-care environments.