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510(k) DEN200001

Cell-Free DNA BCT by Streck, Inc. — Product Code QMA

DEN200001 is an FDA 510(k) premarket notification submitted by Streck, Inc. for the device "Cell-Free DNA BCT". The FDA issued a decision of De Novo Granted on August 7, 2020. The device falls under product code QMA (Blood Collection Device For Cell-Free Nucleic Acid), a Class II device regulated under 21 CFR 862.1676. Streck, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
August 7, 2020
Date Received
January 10, 2020
Clearance Type
Direct
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood Collection Device For Cell-Free Nucleic Acid
Device Class
Class II
Regulation Number
862.1676
Review Panel
CH
Submission Type

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.

Other clearances by Streck, Inc.

  • K260041 — MDx-Chex for BCP (March 27, 2026)
  • K254166 — MDx-Chex for BCN (March 23, 2026)
  • K254167 — MDx-Chex for BCY (March 17, 2026)
  • K231776 — Cell-Free DNA BCT (July 26, 2024)
  • K231221 — MDx-Chex for BC-GP (July 27, 2023)
  • K231223 — MDx-Chex for BC-GN (July 27, 2023)
  • K212576 — MDx-Chex for BCID2 (January 19, 2022)
  • K170091 — UA-Cellular Complete (February 9, 2017)
  • K160588 — XN CHECK BF (December 22, 2016)
  • K160586 — XN-L CHECK (December 22, 2016)

Other clearances for product code QMA

  • K231776 — Cell-Free DNA BCT (July 26, 2024)

FDA data resources