BD MAX Enteric Parasite Panel
by Becton, Dickinson and Company
510(k) K220193
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220193 | Date19 Aug 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- PCH
- Device class
- Class II
- Regulation
- 21 CFR Part 866.3990
- Advisory committee
- Microbiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The BD MAX Enteric Parasite Panel is a Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System, designed for the qualitative detection of enteric parasites. It targets pathogens such as Giardia lamblia, Cryptosporidium spp., and Entamoeba histolytica, enabling rapid identification of parasitic infections in clinical samples. This in vitro diagnostic device leverages nucleic acid amplification technology to provide sensitive and specific results for microbiological analysis. Its multiplex format allows simultaneous testing for multiple targets, improving diagnostic efficiency in clinical microbiology settings.
The panel is intended for use on the BD MAX System, an automated platform that integrates sample extraction and thermocycling into a single workflow. Supplied as a single-use reagent kit, it requires no additional preparation beyond standard laboratory procedures. The device is classified under FDA regulation 866.3990 and holds a Traditional 510(k) clearance (K220193) for substantial equivalence in microbiology applications. Storage and handling follow standard in vitro diagnostic (IVD) protocols, ensuring sterility and performance integrity until use.
From the manufacturer
The BD MAX™ system offers you an efficient path to improved clinical outcomes by combining and automating extraction and thermocycling into a single platform capable of running both FDA-cleared and open system assays.
The BD MAX™ Enteric Parasite Panel targets the three most common parasites in developed countries - Giardia lamblia, Cryptosporidium spp.
Other devices from Becton, Dickinson and Company
Questions
AI-generated answers, 20 Sep 2026
What types of enteric parasites can the BD MAX Enteric Parasite Panel detect, and how does it work to identify them?
The BD MAX Enteric Parasite Panel is designed to qualitatively detect three specific enteric parasites: *Giardia lamblia*, *Cryptosporidium spp.*, and *Entamoeba histolytica*. It uses nucleic acid amplification technology within a multiplex format, meaning it simultaneously tests for these pathogens in a single assay. This approach improves diagnostic efficiency by providing rapid and sensitive results through automated sample processing on the BD MAX System, which integrates extraction and thermocycling into one workflow.
Is the BD MAX Enteric Parasite Panel intended for single-use, and if so, what does this mean for my lab workflow?
Yes, the BD MAX Enteric Parasite Panel is supplied as a single-use reagent kit, meaning each panel is designed for one test run. This eliminates the need for additional preparation beyond standard laboratory procedures, ensuring consistency and reducing the risk of cross-contamination. Your lab workflow will benefit from streamlined handling, as there’s no need to clean or reprocess the panel between uses, aligning with the automated workflow of the BD MAX System.
How should I store the BD MAX Enteric Parasite Panel to maintain its sterility and performance?
The panel follows standard in vitro diagnostic (IVD) storage protocols to preserve sterility and performance. While the exact storage conditions aren’t detailed here, typical IVD guidelines recommend keeping it refrigerated (between 2°C and 8°C) and protected from light until use. Always refer to the included instructions for precise storage instructions, as improper handling could compromise results or sterility.
What platform does the BD MAX Enteric Parasite Panel require for operation, and does it handle sample preparation automatically?
The panel is specifically designed for use on the BD MAX System, an automated platform that combines sample extraction and nucleic acid amplification into a single, integrated workflow. This means the system handles the entire process—from extraction to thermocycling—reducing manual intervention and improving efficiency in clinical microbiology settings. No additional preparation beyond standard laboratory procedures is required.
What regulatory pathway was followed for the BD MAX Enteric Parasite Panel, and how does this affect its use in clinical settings?
The panel received a Traditional 510(k) clearance (K220193) under FDA regulation 866.3990, demonstrating substantial equivalence to a predicate device in microbiology applications. This clearance confirms its compliance with FDA standards for safety and effectiveness, allowing it to be used confidently in clinical settings for the detection of *Giardia lamblia*, *Cryptosporidium spp.*, and *Entamoeba histolytica*. Always ensure your lab adheres to the manufacturer’s instructions and any applicable local regulations.