QMA · Class II · 21 CFR 862.1676

FDA Product Code QMA: Blood Collection Device For Cell-free Nucleic Acid

A Blood Collection Device For Cell-free Nucleic Acids Is A Device Intended For Medical Purposes To Collect, Store, Transport, And Handle Blood Specimens And To Stabilize And Isolate Cell-free Nucleic Acid Components Prior To Further Testing.

Leading manufacturers include Streck, Inc..

2
Total
1
Cleared
308d
Avg days
2020
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 406d recently vs 210d historically

FDA 510(k) Cleared Blood Collection Device For Cell-free Nucleic Acid Devices (Product Code QMA)

2 devices
1–2 of 2
Cleared Jul 26, 2024
Cell-Free DNA BCT
K231776
Streck, Inc.
Chemistry · 406d

About Product Code QMA - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code QMA since 2020, with 1 receiving FDA clearance (average review time: 308 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 QMA have taken an average of 406 days to reach a decision - up from 210 days historically. Manufacturers should account for longer review timelines in current project planning.

QMA devices are reviewed by the Chemistry panel. Browse all Chemistry devices →