POC · Class II · 21 CFR 866.1640

FDA Product Code POC: System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen

To Detect The Presence Of Genetic Markers Of Antimicrobial Resistance By Testing Directly From Clinical Specimens Using Nucleic Acid Amplification Technology.

Leading manufacturers include Cepheid and Check-Points Health B.V..

4
Total
4
Cleared
95d
Avg days
2016
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 28d recently vs 117d historically

FDA 510(k) Cleared System, Nucleic Acid Amplification Test, Dna, Antimicrobial Resistance Marker, Direct Specimen Devices (Product Code POC)

4 devices
1–4 of 4
Cleared Jul 02, 2026
Xpert Carba-R
K261867
Cepheid
Microbiology · 28d
Cleared Aug 29, 2019
BD MAX Check-Points CPO
K190613
Check-Points Health B.V.
Microbiology · 171d
Cleared Jan 09, 2018
Xpert Carba-R
K173263
Cepheid
Microbiology · 90d
Cleared Jun 29, 2016
Xpert Carba-R
K160901
Cepheid
Microbiology · 89d

About Product Code POC - Regulatory Context

510(k) Submission Activity

4 total 510(k) submissions under product code POC since 2016, with 4 receiving FDA clearance (average review time: 95 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 - POC Product Code

Recent submissions under POC have taken an average of 28 days to reach a decision - down from 117 days historically, suggesting improved FDA processing for this classification.

POC devices are reviewed by the Microbiology panel. Browse all Microbiology devices →