Identifiers
- 510(k) Number
- K181427 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 of enteric viral pathogens. It identifies Norovirus GI/GII, Rotavirus, Adenovirus, Sapovirus, and Astrovirus directly from stool samples, enabling rapid and multiplexed molecular diagnostics in microbiology settings.
This assay is intended for use on the BD MAX Instrument, a fully automated platform that integrates extraction and thermocycling into a single workflow. Supplied as a single-use reagent panel, it requires no additional preparation beyond sample application and is intended for in vitro diagnostic use. The system operates under FDA 510(k) clearance (K181427) and adheres to regulatory standards for Class II medical devices, ensuring compliance with microbiology laboratory protocols.
Frequently asked questions
What enteric viruses does the BD MAX Enteric Viral Panel detect, and how does it differ from single-target tests?
The BD MAX Enteric Viral Panel simultaneously detects five enteric viruses—Norovirus GI/GII, Rotavirus, Adenovirus, Sapovirus, and Astrovirus—directly from stool samples. Unlike single-target tests that require separate assays for each pathogen, this multiplex system streamlines workflow by providing results for all five viruses in one run, reducing turnaround time and minimizing sample handling.
Is the BD MAX Enteric Viral Panel designed for single-use, and if so, how does that impact workflow?
Yes, the BD MAX Enteric Viral Panel is supplied as a single-use reagent panel, meaning each panel is intended for one test cycle. This design eliminates the need for cleaning or reprocessing between uses, reducing contamination risks and simplifying compliance with microbiology lab protocols. The fully automated BD MAX Instrument handles extraction and amplification, so only the panel itself requires replacement per sample.
What types of stool samples can be tested with this panel, and are there any special preparation requirements?
The panel is designed for direct testing of stool samples without additional preparation beyond application to the BD MAX Instrument. No dilution, centrifugation, or other preprocessing steps are required, making it suitable for routine clinical use in microbiology labs. The system is intended for in vitro diagnostic use, so samples should follow standard stool collection protocols for enteric pathogen testing.
How does the BD MAX Enteric Viral Panel integrate with the BD MAX Instrument, and what are the key benefits of this combination?
The BD MAX Enteric Viral Panel is specifically designed for use on the BD MAX Instrument, which automates the entire workflow—including nucleic acid extraction and thermocycling—into a single, closed-system process. This integration eliminates manual handling steps, reduces human error, and ensures consistency in results. The system’s automation also accelerates turnaround time compared to traditional manual assays, making it ideal for high-volume microbiology labs.
Are there multiple panel sizes or models available, or is it a fixed-format test?
The BD MAX Enteric Viral Panel is supplied as a fixed-format, single-use reagent panel designed to detect the five specified enteric viruses in one assay. There are no variable sizes or models; each panel is standardized for the multiplex detection of Norovirus GI/GII, Rotavirus, Adenovirus, Sapovirus, and Astrovirus. The panel is paired exclusively with the BD MAX Instrument, ensuring compatibility and performance consistency.
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, BD MAX™ Enteric Viral Panel - 443985 | BD, Automated molecular diagnostics: BD MAX™ enteric viral panel | BD, BD (company) - Wikipedia, Automated molecular diagnostics: BD MAX™ enteric viral panel | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K181427 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K181427 24 fields · synced Sep 18, 2026