DeviceClearance

Product code QMA— Clinical Chemistry

Cell-Free DNA BCT

Classification name
Blood Collection Device For Cell-Free Nucleic Acid
Device class
Class 2
Regulation
21 CFR 862.1676
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code QMA under 21 CFR 862.1676, via openFDA

Market context for product code QMA

FDA has cleared 2 devices under product code QMA between 2020 and 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code QMA

Recent clearances under product code QMA

Data sourced from openFDA. This site is unofficial and independent of the FDA.