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SAS Influenza A Test

FDA 510(k)

Class II (US FDA 510(k))

510(k) K041441

by Sa Scientific, Inc.

Identifiers

510(k) Number
K041441 FDA 510(k)
FDA Product Code
PSZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3328 FDA 510(k)
Regulation Number
866.3328 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SAS Influenza A Test is a rapid diagnostic device designed to detect Influenza A viral antigens. It employs monoclonal antibodies to identify Type A nucleoproteins in clinical samples, providing a qualitative result through visual indication of colored lines on a membrane strip.

This single-use, in vitro diagnostic device is intended for use in clinical laboratory settings. Supplied as a rapid test kit, it requires no special storage conditions beyond refrigeration and is regulated under FDA 510(k) clearance (K041441). The test follows a simple procedure involving sample extraction and capillary migration for result interpretation, with no MRI safety considerations.

Frequently asked questions

What is the SAS Influenza A Test used for?

The SAS Influenza A Test is designed to detect Influenza A viral antigens in clinical samples. It uses monoclonal antibodies to identify Type A nucleoproteins, providing a qualitative result through a visible colored line on a membrane strip. This helps clinicians quickly confirm suspected Influenza A infections in laboratory settings.

How is the SAS Influenza A Test supplied and stored?

The SAS Influenza A Test is supplied as a rapid test kit, intended for single-use only. No special storage conditions are required beyond refrigeration, ensuring stability and reliability until use.

Is the SAS Influenza A Test sterile and reusable?

The SAS Influenza A Test is a single-use device, meaning each test kit is intended for one-time use only. Sterility is maintained through proper packaging and handling, but reuse is not recommended or supported by the manufacturer.

What are the key steps in using the SAS Influenza A Test?

The test follows a straightforward procedure involving sample extraction and capillary migration for result interpretation. After applying the sample to the test device, results are visually confirmed by the appearance of colored lines on the membrane strip within a short timeframe, typically designed for rapid diagnostic use.

Does the SAS Influenza A Test require any special handling or regulatory considerations?

The SAS Influenza A Test is regulated under FDA 510(k) clearance (K041441) and is classified as a Class II medical device. It is intended for use in clinical laboratory settings only, with no MRI safety considerations. The test adheres to standard in vitro diagnostic (IVD) practices and should be handled according to laboratory protocols for infectious disease testing.

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: SAScientific and You - SA Scientific Ltd., PDF 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS SAS Influenza A Test, Sas Influenza A Test 510 (k) FDA Premarket Notification K041441 SA ..., SAS FLUALERT A & B, SAS INFLUENZA A TEST by SA SCIENTIFIC LTD. | FDA ...

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) K041441 24 fields · synced Oct 1, 2026