Identifiers
- 510(k) Number
- K220607 FDA 510(k)
- FDA Product Code
- PCH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3990 FDA 510(k)
- Regulation Number
- 866.3990 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD MAX Enteric Viral Panel is a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, designed for the simultaneous detection and differentiation of enteric viral pathogens. This in vitro diagnostic device leverages nucleic acid amplification technology to identify targets such as Norovirus, Rotavirus, Adenovirus, Sapovirus, and Astrovirus, enabling rapid and accurate pathogen identification from clinical specimens. It falls under the classification of a Class II medical device, as defined by regulatory authorities, and is intended for use in microbiology laboratories.
This panel is supplied as a single-use, closed-system assay for automated processing on the BD MAX™ platform, which integrates sample extraction and thermocycling. The device is not intended for MRI use and requires adherence to standard laboratory sterility protocols. It is regulated under FDA 510(k) clearance (K220607) and is intended for use in clinical settings where gastrointestinal pathogen detection is required. Storage and handling must comply with manufacturer guidelines to maintain assay integrity.
Frequently asked questions
What types of enteric viruses can the BD MAX Enteric Viral Panel detect and differentiate simultaneously?
The BD MAX Enteric Viral Panel is designed to simultaneously detect and differentiate five specific enteric viral pathogens: Norovirus, Rotavirus, Adenovirus, Sapovirus, and Astrovirus. This multiplex nucleic acid-based assay allows for rapid identification of these viruses in clinical specimens, streamlining diagnostic workflows in microbiology laboratories.
Is the BD MAX Enteric Viral Panel intended for single-use or reusable applications, and how should it be handled?
The BD MAX Enteric Viral Panel is supplied as a single-use, closed-system assay, meaning each panel is intended for one test cycle only. Due to its closed-system design, it does not require manual handling of specimens after initial preparation, reducing contamination risks. Standard laboratory sterility protocols must be followed during setup and operation to maintain assay integrity.
What platform is required to run the BD MAX Enteric Viral Panel, and does it include automated sample processing?
The BD MAX Enteric Viral Panel is designed exclusively for use on the BD MAX™ platform, which integrates both automated sample extraction and thermocycling. This eliminates the need for manual nucleic acid extraction, simplifying workflows and reducing human error in microbiology labs.
How should the BD MAX Enteric Viral Panel be stored, and are there any special handling requirements?
Storage and handling of the BD MAX Enteric Viral Panel must comply with the manufacturer’s guidelines to preserve assay integrity. While specific storage conditions (e.g., temperature, humidity) are not detailed here, the closed-system design implies it should be stored in a controlled environment, protected from physical damage or contamination. Always refer to the included instructions for precise storage instructions.
What regulatory pathway was followed for FDA clearance of the BD MAX Enteric Viral Panel, and what does this mean for clinical use?
The BD MAX Enteric Viral Panel received FDA 510(k) clearance (K220607) under a Traditional Review pathway, with a determination of Substantially Equivalent to a predicate device. This clearance confirms the device meets FDA safety and effectiveness standards for in vitro diagnostic use in microbiology laboratories. The classification as a Class II device reflects its moderate risk level, requiring compliance with specific manufacturing and labeling controls.
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: BD MAX™ Enteric Viral Panel - 443985 | BD, Automated molecular diagnostics: BD MAX™ enteric viral panel | BD, Becton Dickinson – Wikipedia, BD MAX™ Enteric Viral Panel - 443985 | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220607 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K220607 24 fields · synced Sep 20, 2026