BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/ml
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K151320 FDA 510(k)
- FDA Product Code
- LON FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.1645 FDA 510(k)
- Regulation Number
- 866.1645 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/ml is an automated antimicrobial susceptibility testing system designed for microbiology laboratories. It identifies bacterial isolates and determines their susceptibility to antimicrobial agents, including ertapenem, using a standardized, automated process. The system supports rapid and accurate detection of resistance patterns, aiding in targeted antibiotic therapy and infection control. It falls under the category of automated antimicrobial susceptibility test systems with short incubation times, as defined by regulatory classifications.
This device is intended for use in clinical microbiology laboratories and is supplied as a reusable instrument with disposable consumables. The system operates under controlled laboratory conditions and requires proper training for operation and maintenance. It is classified as a Class II medical device under FDA regulations and has received 510(k) clearance through a traditional review pathway. Sterility and single-use requirements apply only to associated consumables, while the core system undergoes routine cleaning and validation procedures. Compliance with FDA regulations, including registration number 3027320620, ensures adherence to safety and performance standards for antimicrobial susceptibility testing.
Frequently asked questions
What is the primary purpose of the BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/ml in a clinical setting?
The BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/ml is designed to automate the identification of bacterial isolates and determine their susceptibility to antimicrobial agents, including ertapenem. This helps microbiology laboratories rapidly and accurately detect resistance patterns, enabling targeted antibiotic therapy and improving infection control outcomes.
Is the BD Phoenix Automated Microbiology System reusable, or are there single-use components involved?
The core BD Phoenix Automated Microbiology System itself is a reusable instrument. However, it requires disposable consumables, which are intended for single-use and must adhere to sterility standards. The reusable system undergoes routine cleaning and validation procedures to maintain performance.
What type of regulatory clearance does this device hold, and how was it reviewed?
The BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/ml is classified as a Class II medical device and has received FDA 510(k) clearance through a traditional review pathway. This means its safety and performance were evaluated by the FDA’s Microbiology (MI) Advisory Committee to ensure it is substantially equivalent to a predicate device.
Are there specific storage requirements for the disposable consumables used with this system?
While the provided data does not specify exact storage conditions, the disposable consumables for the BD Phoenix Automated Microbiology System are intended to be sterile and single-use. Proper storage—typically in a clean, dry environment away from direct sunlight and extreme temperatures—is critical to preserve sterility and functionality before use.
How does this system differ from manual antimicrobial susceptibility testing methods?
Unlike manual methods, the BD Phoenix Automated Microbiology System-Ertapenem 0.0625–8 µg/ml automates the process of identifying bacterial isolates and testing their susceptibility to antimicrobials, including ertapenem. This reduces human error, shortens incubation times, and accelerates results—typically providing faster and more consistent outcomes for targeted antibiotic therapy decisions.
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: Becton Dickinson – Wikipedia, BD (company) - Wikipedia
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K151320 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (1)
- FDA 510(k) K151320 24 fields · synced Sep 20, 2026