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D3 Dfa Metapneumovirus Identification Kit

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090073

by Diagnostic Hybrids, Inc.

Identifiers

510(k) Number
K090073 FDA 510(k)
FDA Product Code
OMG 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 D³ DFA Metapneumovirus Identification Kit is a fluorescent antibody assay designed for the qualitative detection and identification of human metapneumovirus (hMPV) antigens. It employs immunofluorescence with a blend of three monoclonal antibodies to detect viral presence in clinical specimens, aiding in respiratory infection diagnostics.

This kit is intended for use with nasal and nasopharyngeal swabs, aspirates/washes, or cell culture samples. Supplied as a single-use diagnostic tool, it requires no additional regulatory approval beyond its FDA 510(k) clearance (K090073) under the Microbiology advisory committee. Storage and handling follow standard immunofluorescence assay protocols, ensuring specimen integrity and assay accuracy.

Frequently asked questions

What types of clinical samples can the D³ DFA Metapneumovirus Identification Kit detect human metapneumovirus in, and how should they be collected?

The kit is designed to detect human metapneumovirus (hMPV) antigens in nasal swabs, nasopharyngeal swabs, aspirates/washes, or cell culture samples. These samples should be collected following standard clinical practices for respiratory infection diagnostics to ensure accuracy and reliability of the assay results.

Is the D³ DFA Metapneumovirus Identification Kit intended for single-use or repeated use, and why?

The kit is explicitly supplied as a single-use diagnostic tool. This design ensures specimen integrity, prevents cross-contamination between samples, and maintains the accuracy of the immunofluorescence assay, which relies on the precision of the monoclonal antibodies included in each kit.

How should the D³ DFA Metapneumovirus Identification Kit be stored, and what considerations should be taken into account?

Storage follows standard immunofluorescence assay protocols to preserve specimen integrity and assay accuracy. While the exact storage conditions are not detailed here, typical guidelines for immunofluorescence kits—such as refrigeration or protection from light and moisture—should be followed. Always refer to the included instructions for use for precise storage instructions.

What regulatory pathway was followed for the FDA clearance of this kit, and what does that mean for its intended use?

The kit received FDA clearance through a 510(k) submission under the Microbiology advisory committee, classified as Substantially Equivalent (SESE). This means the device was determined to be as safe and effective as a legally marketed predicate device, confirming its compliance with FDA standards for diagnostic assays. The clearance does not define clinical indications but confirms the kit’s regulatory standing for detecting hMPV antigens in respiratory specimens.

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: D3 DFA METAPNEUMOVIRUS IDENTIFICATION KIT (K090073) — FDA 510(k ..., D³™ DFA Metapneumovirus Identification Kit | QuidelOrtho, D³™ DFA Metapneumovirus Identification Kit | QuidelOrtho

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Diagnostic Hybrids, Inc.

Sources (1)

  • FDA 510(k) K090073 24 fields · synced Sep 19, 2026