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BD MAX - bd Max(tm) Instrument

FDA 510(k)

Class II (US FDA 510(k))

510(k) K140111

by Becton, Dickinson and Company

Identifiers

510(k) Number
K140111 FDA 510(k)
FDA Product Code
PCI FDA 510(k)
Models / Variants
Bd Max(tm) Enteric Bacterial Panel FDA 510(k)
bd Max(tm) Instrument 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 Bacterial Panel is a Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay System, designed for the simultaneous detection of bacterial pathogens associated with enteric infections. It employs nucleic acid amplification technology to identify key organisms, including Campylobacter, Salmonella, Shigella, and Shiga toxin-producing E. coli, enabling rapid and targeted diagnostic testing for infectious gastroenteritis.

This system is intended for use in clinical microbiology laboratories and is supplied as a multiplex assay panel paired with the BD MAX Instrument, a fully automated platform for nucleic acid extraction and thermocycling. The panel is single-use, requires no additional sterilization, and is compatible with standard laboratory workflows. Regulatory clearance under FDA 510K (K140111) confirms its classification as a Class II device under the Gastrointestinal Bacterial Panel category (Regulation 866.3990). Storage and handling follow manufacturer guidelines for nucleic acid-based assays.

Frequently asked questions

What types of bacterial infections can the BD MAX Enteric Bacterial Panel detect simultaneously?

The BD MAX Enteric Bacterial Panel is designed to simultaneously detect key bacterial pathogens linked to gastrointestinal infections, including *Campylobacter*, *Salmonella*, *Shigella*, and Shiga toxin-producing *E. coli*. This multiplex assay allows for rapid identification of multiple pathogens in a single test, streamlining diagnostic workflows for infectious gastroenteritis.

Is the BD MAX Enteric Bacterial Panel meant for single-use or can it be reused?

The BD MAX Enteric Bacterial Panel is explicitly designed for single-use only. Since it is a nucleic acid-based assay, it does not require additional sterilization between uses, and the manufacturer’s guidelines align with this one-time-use approach to ensure accuracy and safety.

How is the BD MAX Enteric Bacterial Panel integrated into a clinical lab’s workflow?

The panel is paired with the BD MAX Instrument, a fully automated platform that handles nucleic acid extraction and thermocycling. This integration allows for seamless incorporation into standard microbiology lab workflows, enabling rapid, high-throughput testing for enteric bacterial infections without manual intervention.

What storage and handling requirements apply to the BD MAX Enteric Bacterial Panel?

Storage and handling follow standard protocols for nucleic acid-based assays, as outlined by the manufacturer. While specific conditions (e.g., temperature, humidity) are not detailed here, the panel is designed for compatibility with typical clinical lab environments, ensuring stability and reliability when stored and used according to the provided instructions.

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, Bd Max™, BD MAX Enteric solutions, BD (company) - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (1)

  • FDA 510(k) K140111 24 fields · synced Oct 6, 2026