PAM · Class II · 21 CFR 866.3365

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 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
1–6 of 6
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490
Luminex Corporation
Microbiology · 206d

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 Review Time

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 →