BD MAX Extended Enteric Bacterial Panel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K170308 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 Extended Enteric Bacterial Panel is a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, designed for the molecular detection of enteric bacterial pathogens. This in vitro diagnostic device automates nucleic acid extraction and amplification to identify multiple bacterial targets associated with gastrointestinal infections, supporting rapid diagnostic decision-making in microbiology laboratories.
The system is intended for use in clinical microbiology settings and is supplied as a single-use reagent panel for the BD MAX System. It requires no additional sterilization and is regulated under FDA 510(k) clearance (K170308) as a Class II device (866.3990). Storage and handling follow manufacturer guidelines for nucleic acid-based assays, with results delivered within approximately two hours of sample processing.
Frequently asked questions
What types of gastrointestinal infections can the BD MAX Extended Enteric Bacterial Panel detect, and how does it work?
The BD MAX Extended Enteric Bacterial Panel is a multiplex nucleic acid-based assay designed to detect multiple bacterial targets linked to gastrointestinal infections. It automates nucleic acid extraction and amplification to identify enteric bacterial pathogens, enabling rapid and simultaneous testing for various pathogens in a single run. This helps microbiology labs streamline diagnostic workflows and accelerate decision-making for patient care.
Is the BD MAX Extended Enteric Bacterial Panel intended for single-use, or can it be reused?
The panel is explicitly supplied as a single-use reagent for the BD MAX System. It is not designed for sterilization or reuse, ensuring consistency, safety, and compliance with nucleic acid assay protocols. Each panel is intended for one test run only.
How long does it typically take to get results from the BD MAX Extended Enteric Bacterial Panel?
The system delivers results within approximately two hours of sample processing. This rapid turnaround supports timely clinical decision-making in microbiology labs, reducing delays in diagnosing gastrointestinal infections.
What regulatory pathway was followed for FDA clearance of this device?
The BD MAX Extended Enteric Bacterial Panel received FDA 510(k) clearance under the traditional review pathway, classified as a Class II device (product code: PCH). The submission was determined *substantially equivalent* to a predicate device and reviewed by the Microbiology Advisory Committee (MI). The clearance number is K170308.
How should the BD MAX Extended Enteric Bacterial Panel be stored, and are there any special handling requirements?
Storage and handling follow standard manufacturer guidelines for nucleic acid-based assays. While specific conditions (e.g., temperature) are detailed in the accompanying documentation, the panel is designed for use in clinical microbiology labs with appropriate infrastructure. No additional sterilization is required, as it is single-use and pre-packaged for immediate use on the BD MAX System.
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 Bacterial Panel - 442963 | BD, More accurate diagnosis BD MAX™ Enteric Solutions BD, BD (company) - Wikipedia, More accurate diagnosis: BD MAX™ Enteric Solutions | BD, BD MAX Enteric solutions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K170308 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K170308 24 fields · synced Sep 18, 2026