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
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

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
Not Cleared Aug 07, 2020
Cell-Free DNA BCT
DEN200001
Streck, Inc.
Chemistry · 210d

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 declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.