Identifiers
- 510(k) Number
- K931302 FDA 510(k)
- FDA Product Code
- JHI 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 SAS Pregnancy Strip is a visual diagnostic device designed to detect human chorionic gonadotropin (hCG) in urine, confirming pregnancy. It functions as a lateral flow immunoassay strip, providing a qualitative result indicating the presence of hCG, a hormone produced during pregnancy.
This device is supplied as a single-use, non-sterile test kit containing either 25 or 50 strips. It is intended for prescription use and falls under FDA Class II regulatory classification with Special Controls. Results are typically available within 4 minutes, and the device is regulated under FDA 510(k) clearance (K931302) with product code JHI.
Frequently asked questions
What is the SAS Pregnancy Strip used for?
The SAS Pregnancy Strip is a visual diagnostic device designed to detect human chorionic gonadotropin (hCG) in urine, confirming pregnancy. It functions as a lateral flow immunoassay, providing a qualitative result that indicates whether hCG—a hormone produced during pregnancy—is present in the sample.
How is the SAS Pregnancy Strip supplied, and is it single-use?
The SAS Pregnancy Strip is supplied as a single-use, non-sterile test kit containing either 25 or 50 individual strips. Each strip is intended for one-time use only, ensuring accuracy and hygiene for each test.
How long does it take to get results with the SAS Pregnancy Strip?
Results are typically available within 4 minutes after applying the urine sample to the test strip. This rapid turnaround makes it convenient for immediate confirmation of pregnancy status.
What are the available sizes or models for the SAS Pregnancy Strip?
The SAS Pregnancy Strip is available in two kit sizes: one containing 25 strips and another containing 50 strips. Both sizes are designed for prescription use and are intended for clinical or home testing under medical supervision.
How should the SAS Pregnancy Strip be stored?
While the device data does not specify storage conditions, lateral flow immunoassay strips like this are generally recommended to be stored in a cool, dry place, protected from direct sunlight and extreme temperatures. Always follow the manufacturer’s instructions included with the kit for optimal performance.
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: SAS PREGNANCY STRIP (K931302) - FDA 510 (k), SAS PREGNANCY STRIP (K931302) — FDA 510 (k) | Innolitics, Fertility and Pregnancy - SA Scientific Ltd., Sas Pregnancy Strip 510 (k) K931302 - FDA.report, K965253 FDA 510 (k) - SAS PREGNANCY STRIP | Sascie
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K931302 | Class II | Active |
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Manufacturer
- Manufacturer
- Sa Scientific, Inc.
Sources (1)
- FDA 510(k) K931302 24 fields · synced Oct 1, 2026