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SAS HCG-Check

FDA 510(k)

Class II (US FDA 510(k))

510(k) K991193

by Sa Scientific, Inc.

Identifiers

510(k) Number
K991193 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 SAS HCG-Check is a pregnancy test kit designed to detect human chorionic gonadotropin (hCG) in urine samples. It functions as an over-the-counter diagnostic tool for confirming early pregnancy by providing a qualitative result based on the presence of hCG, a hormone produced during pregnancy.

This device is intended for home use and is supplied as a single-use, non-sterile test kit. It is classified as a Class II medical device under FDA regulations (product code LCX) and requires no special storage conditions beyond room temperature. The device received FDA 510(k) clearance under traditional review, with no MRI safety considerations or reusable components specified.

Frequently asked questions

What is the SAS HCG-Check used for and how does it work?

The SAS HCG-Check is a pregnancy test kit designed for home use to detect the presence of human chorionic gonadotropin (hCG) in urine samples. It provides a qualitative result, meaning it indicates whether hCG is present (suggesting pregnancy) or not. The test works by detecting hCG, a hormone produced during pregnancy, in the urine of a user.

Is the SAS HCG-Check intended for single-use or can it be reused?

The SAS HCG-Check is explicitly designed as a single-use device. Each kit is meant for one-time use only, as indicated in the product description.

What storage conditions are required for the SAS HCG-Check?

The SAS HCG-Check does not require any special storage conditions beyond keeping it at room temperature. This makes it convenient for home use without needing refrigeration or controlled environments.

Is the SAS HCG-Check sterile, and if not, what does that mean for its use?

The SAS HCG-Check is explicitly labeled as non-sterile. Since it is intended for home use with urine samples, non-sterility is acceptable as the test does not involve invasive procedures or sterile environments. Users should follow the provided instructions to ensure accurate results.

How was the SAS HCG-Check approved by the FDA, and what does that mean for its regulatory status?

The SAS HCG-Check received FDA 510(k) clearance under traditional review, with a determination of substantial equivalence to a predicate device. This means the FDA reviewed it and found it to be as safe and effective as a previously approved pregnancy test kit. The device is classified as a Class II medical device under FDA regulations, which is typical for moderate-risk devices like pregnancy tests.

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: K991193 FDA 510 (k) - SAS HCG-CHECK | Sa Scientific, Inc., SAS HCG-CHECK 510 (k) K991193 - FDA.report, fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sa Scientific, Inc.

Sources (1)

  • FDA 510(k) K991193 24 fields · synced Sep 19, 2026