FDA Product Code PAM: Gram-positive Bacteria And Their Resistance Markers
A Qualitive Multiplexed In Vitro Diagnostic Device To Detect And Identify Gram Positive Bacteria And Resistant Markers In Positive Blood Cultures.
Leading manufacturers include Genmark Diagnostics, Incorporated and Luminex Corporation.
6
Total
5
Cleared
147d
Avg days
2012
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
Review times increasing: avg
206d
recently vs 136d historically
FDA 510(k) Cleared Gram-positive Bacteria And Their Resistance Markers Devices (Product Code PAM)
6 devices
Cleared
Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
Luminex Corporation
Microbiology
206d
Cleared
Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
Genmark Diagnostics, Incorporated
Microbiology
178d
About Product Code PAM - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code PAM since 2012, with 5 receiving FDA clearance (average review time: 147 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - PAM Product Code
Recent submissions under PAM have taken an average of 206 days to reach a decision - up from 136 days historically. Manufacturers should account for longer review timelines in current project planning.
PAM devices are reviewed by the Microbiology panel. Browse all Microbiology devices →