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 Nanosphere, Inc., Great Basin Scientific, Inc. and Icubate, Inc..

7
Total
6
Cleared
159d
Avg days
2012
Since
Growing category - 2 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 216d recently vs 136d historically

FDA 510(k) Cleared Gram-positive Bacteria And Their Resistance Markers Devices (Product Code PAM)

7 devices
1–7 of 7
Cleared Aug 06, 2026
QIAstat-Dx BCID GPF Plus AMR Panel
K254194
QIAGEN GmbH
Microbiology · 226d
Cleared Jun 06, 2025
LIAISON PLEX Gram-Positive Blood Culture Assay
K243490
Luminex Corporation
Microbiology · 206d
Cleared Dec 20, 2018
ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel
K181663
Genmark Diagnostics, Incorporated
Microbiology · 178d
Cleared Aug 08, 2017
iC-GPC Assay TM for use on the iC-SystemTM
K163390
Icubate, Inc.
Microbiology · 249d
Cleared Mar 25, 2016
Great Basin Staph ID/R Blood Culture Panel
K152470
Great Basin Scientific, Inc.
Microbiology · 207d
Cleared Sep 19, 2012
VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST
K122514
Nanosphere, Inc.
Microbiology · 33d
Not Cleared Jun 26, 2012
VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP)
DEN120014
Nanosphere, Inc.
Microbiology · 11d

About Product Code PAM - Regulatory Context

510(k) Submission Activity

7 total 510(k) submissions under product code PAM since 2012, with 6 receiving FDA clearance (average review time: 159 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 510(k) Review Time - PAM Product Code

Recent submissions under PAM have taken an average of 216 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 →