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Quidel Molecular Influenza A + B Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131728

by Quidel Corp.

Identifiers

510(k) Number
K131728 FDA 510(k)
FDA Product Code
OZE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.3980 FDA 510(k)
Regulation Number
866.3980 FDA 510(k)
Advisory Committee
Microbiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Quidel Molecular Influenza A + B Assay is a multiplex real-time RT-PCR assay designed for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA. It is indicated for use with nasal and nasopharyngeal swab specimens collected from patients exhibiting signs and symptoms of respiratory infection to aid in differential diagnosis.

This assay utilizes viral nucleic acids extracted from patient samples via the NucliSENS easyMAG automated extraction platform. The test is authorized under FDA 510(k) clearance K131728 and is performed as a multiplex reaction in a single tube.

Frequently asked questions

What is the intended use of the Quidel Molecular Influenza A + B Assay?

This assay is designed for the in vitro qualitative detection and differentiation of influenza A and influenza B viral RNA. It is intended to aid in the differential diagnosis of patients who are exhibiting signs and symptoms of a respiratory infection.

What types of patient specimens are required for this test?

The assay is indicated for use with nasal and nasopharyngeal swab specimens. These samples are collected from patients presenting with clinical symptoms of respiratory illness to ensure accurate detection of viral RNA.

How is the viral nucleic acid processed for this assay?

The test utilizes viral nucleic acids that are extracted from patient samples using the NucliSENS easyMAG automated extraction platform. Once extracted, the assay is performed as a multiplex reaction within a single tube.

What is the regulatory status of this influenza assay?

The Quidel Molecular Influenza A + B Assay is authorized under FDA 510(k) clearance K131728. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.

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: QUIDEL MOLECULAR INFLUENZA A + B ASSAY (K131728) - Innolitics, PDF Quidel Corporation Quidel Molecular Influenza A B Assay 8/26/201316, SOLANA™ Influenza A+B Assay | QuidelOrtho

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quidel Corp.

Sources (1)

  • FDA 510(k) K131728 24 fields · synced Sep 27, 2026