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510(k) K231469

PAXgene® Blood DNA Tube by Preanalytix GmbH — Product Code PJE

K231469 is an FDA 510(k) premarket notification submitted by Preanalytix GmbH for the device "PAXgene® Blood DNA Tube". The FDA issued a decision of Substantially Equivalent on June 21, 2023. The device falls under product code PJE (Blood/Plasma Collection Device For Dna Testing), a Class II device regulated under 21 CFR 862.1675. Preanalytix GmbH has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2023
Date Received
May 22, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Blood/Plasma Collection Device For Dna Testing
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type

A blood collection device for DNA testing is an in vitro diagnostics device intended to collect and transport blood specimens to the laboratory for clinical DNA testing.

Other clearances by Preanalytix GmbH

  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K082150 — MODIFICATION TO PAXGENE BLOOD RNA SYSTEM (February 4, 2009)
  • DEN050003 — PAXGENE BLOOD RNA SYSTEM (April 18, 2005)

Other clearances for product code PJE

  • K142821 — PAXgene Blood DNA Tube (September 9, 2015)
  • K042927 — VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES (April 15, 2005)
  • K031359 — S-MONOVETTE EDTA K2-GEL (September 12, 2003)
  • K014104 — VACUETTE EDTA K2 TUBES (February 1, 2002)
  • K012043 — VACUETTE EDTA K2 GEL TUBES (September 24, 2001)
  • K010328 — MULTIPLE (IZON DNA BLOOD COLLECTION KIT) (April 9, 2001)
  • K972075 — VACUTAINER BRAND PPT PLASMA PREPARATION TUBE (February 24, 1998)

FDA data resources