BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K214122 FDA 510(k)
- FDA Product Code
- PCI 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 and BD MAX Extended Enteric Bacterial Panel are Gastrointestinal Bacterial Panel Multiplex Nucleic Acid-Based Assay Systems designed for the molecular detection of enteric bacterial pathogens. These assays leverage nucleic acid amplification technology to identify bacteria responsible for infectious diarrheal diseases, enabling rapid and precise diagnostic testing. The panels are intended for use in microbiology laboratories to support clinical decision-making in gastrointestinal infections.
These assays are supplied as FDA-cleared in vitro diagnostic devices, intended for single-use in clinical laboratory settings. The BD MAX system automates nucleic acid extraction and amplification, providing standardized workflows for high-throughput testing. The panels are sterile and require proper storage at controlled temperatures as specified in the manufacturer’s instructions. Regulatory compliance is ensured under FDA 510(k) clearance (K214122), adhering to 21 CFR Part 866.3990 for nucleic acid-based diagnostic devices.
Frequently asked questions
What types of gastrointestinal infections can the BD MAX Enteric Bacterial Panel detect, and how does it differ from the Extended version?
The BD MAX Enteric Bacterial Panel and BD MAX Extended Enteric Bacterial Panel are designed to detect enteric bacterial pathogens responsible for infectious diarrheal diseases using nucleic acid amplification technology. While the base panel identifies key bacterial causes, the Extended version expands coverage to include additional pathogens, providing broader diagnostic capabilities for clinicians evaluating suspected gastrointestinal infections. Both panels automate extraction and amplification on the BD MAX system for streamlined workflows.
Are these panels intended for reuse in a clinical setting, and how should they be stored?
No, these panels are single-use only and must not be reused after opening or testing. They are supplied sterile, so proper storage at controlled temperatures—per the manufacturer’s instructions—is critical to maintain integrity. Failure to follow storage guidelines could compromise assay performance and diagnostic accuracy.
What regulatory pathway was followed for FDA clearance of these panels, and what class device classification do they hold?
The BD MAX Enteric Bacterial Panels were cleared via a traditional 510(k) pathway (K214122) under FDA’s 510(k) clearance, demonstrating substantial equivalence to a predicate device. They are classified as Class II devices (device class code: 2) under 21 CFR Part 866.3990 for nucleic acid-based diagnostic assays, ensuring compliance with stringent regulatory standards for molecular diagnostics.
How does the BD MAX system automate the testing process for these panels, and what clinical workflow benefits does this provide?
The BD MAX system automates nucleic acid extraction and amplification, eliminating manual handling steps and reducing human error. This integration enables high-throughput testing in microbiology labs, standardizing workflows for faster turnaround times while maintaining precision. Clinicians benefit from streamlined diagnostics, enabling quicker clinical decision-making in gastrointestinal infection cases.
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, Becton Dickinson – Wikipedia, BD MAX™ Extended Enteric Bacterial Panel - 443812 | BD
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K214122 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K214122 24 fields · synced Sep 20, 2026