Bd Phoenix Automated Microbiology System Trimethoprim - Gn 0.5-16 Ug/Ml

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

510(k) Number

K030986 ↗

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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• What types of bacteria does this device test for susceptibility to trimethoprim, and how does it help in clinical decision-making?

  This device tests Gram-negative bacteria for antimicrobial susceptibility to trimethoprim, with a concentration range of 0.5–16 µg/ml. It automates the detection of bacterial growth and response to antimicrobial agents, providing rapid results to help clinicians select the most effective antimicrobial therapy for infections caused by these bacteria.

• Is the BD Phoenix Automated Microbiology System itself single-use, or are there disposable components that need to be replaced?

  The BD Phoenix Automated Microbiology System is a reusable instrument, but it requires disposable consumables, specifically AST panels, for each use. These consumables may need sterile handling as directed by the manufacturer, though the instrument itself is not sterile.

• What regulatory pathway was followed for this device’s clearance, and what class does it fall under?

  This device received a Traditional 510(k) clearance from the FDA and is classified as a Class II medical device. The clearance was based on a determination of substantial equivalence to a predicate device, as indicated by the 'decision_code: SESE' and 'clearance_type: Traditional' in the submission.

• How does the automated testing process differ from traditional manual methods, and what advantages does it offer?

  Unlike traditional manual methods, the BD Phoenix Automated Microbiology System streamlines antimicrobial susceptibility testing (AST) by automating microbial growth detection and response evaluation. This reduces human error, speeds up results, and allows for consistent, rapid analysis of bacterial susceptibility to trimethoprim and other agents, improving efficiency in clinical microbiology labs.