FDA Product Code PEN: Gram-negative Bacteria And Associated Resistance Markers
A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram-negative Bacteria And Resistance Markers In Positive Blood Cultures.
Leading manufacturers include Luminex Corporation and Biofire Diagnostics, LLC.
FDA 510(k) Cleared Gram-negative Bacteria And Associated Resistance Markers Devices (Product Code PEN)
About Product Code PEN - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code PEN since 2013, with 11 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 2 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
FDA review times for PEN submissions have been consistent, averaging 109 days recently vs 108 days historically.
PEN devices are reviewed by the Microbiology panel. Browse all Microbiology devices →