FDA Product Code QZX: Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing
Processing Device That Includes Associated Reagents, When Applicable, That Is Intended To Recover Microbes From Positive Blood Cultures For Inoculum Preparation. The Prepared Inoculum Is Intended For Subsequent Use In Antimicrobial Susceptibility Testing.
Leading manufacturers include Selux Diagnostics, Inc. and Avails Medical, Inc..
FDA 510(k) Cleared Positive Blood Culture Processor For Inoculum Preparation Used For Antimicrobial Susceptibility Testing Devices (Product Code QZX)
About Product Code QZX - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QZX since 2024, with 3 receiving FDA clearance (average review time: 264 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 2 in the prior period.
FDA Review Time
Recent submissions under QZX have taken an average of 88 days to reach a decision - down from 353 days historically, suggesting improved FDA processing for this classification.
QZX devices are reviewed by the Microbiology panel. Browse all Microbiology devices →