Bd Phoenix Automated Microbiology System - Erythromycin-0.0625-8 Ug/Ml, and Quinupristin/Dalfopristin-0.25-4 Ug/Ml

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K060218 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

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• What is the BD Phoenix Automated Microbiology System with erythromycin and quinupristin/dalfopristin used for?

  This system is designed for rapid in vitro antimicrobial susceptibility testing of aerobic and facultative anaerobic Gram-negative and Gram-positive bacteria from human clinical isolates. It helps determine bacterial resistance patterns to specific antimicrobial agents, including erythromycin (0.0625–8 µg/ml) and quinupristin/dalfopristin (0.25–4 µg/ml), streamlining workflows in clinical microbiology labs.

• How is the BD Phoenix Automated Microbiology System supplied, and are the consumables sterile?

  The system is supplied as a reusable instrument with disposable consumables. While the instrument itself is non-sterile, the consumables may require sterile handling as per manufacturer guidelines. This ensures proper use in clinical settings where sterility is critical for patient safety.

• Is the BD Phoenix Automated Microbiology System single-use or reusable?

  The BD Phoenix Automated Microbiology System itself is a reusable instrument. However, it relies on disposable consumables for each testing cycle, which must be replaced after use. This design balances durability with hygiene and workflow efficiency.

• What regulatory pathway does the BD Phoenix Automated Microbiology System follow?

  The device follows the FDA 510(k) clearance pathway, specifically under the classification of substantially equivalent (SESE) to a predicate device. It adheres to regulatory standards outlined in 21 CFR Part 866.1645, ensuring compliance with antimicrobial susceptibility testing requirements in clinical microbiology.

• Are there any special storage conditions or MRI safety considerations for this device?

  The regulatory data does not specify any special storage conditions or MRI safety information for the BD Phoenix Automated Microbiology System. Standard laboratory storage practices should be followed to maintain optimal performance and longevity of the reusable instrument.