510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K231469Substantially Equivalent

PAXgene® Blood DNA Tube

Preanalytix GmbH, Hombrechtikon, CH / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231469 is the FDA 510(k) clearance record for PAXgene® Blood DNA Tube, a class II device, cleared for Preanalytix GmbH on under FDA product code PJE (Blood/Plasma Collection Device For Dna Testing). FDA's definition for product code PJE reads: "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". FDA records list 4 510(k) clearances for Preanalytix GmbH, from to . As of , FDA records show no recalls naming K231469.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PJE Blood/Plasma Collection Device For Dna Testing
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Preanalytix GmbH Garstligweg 8, Hombrechtikon, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PJE

Trailing 12 months

FDA records hold no clearances under product code PJE in the trailing twelve months.

FDA records show no clearances under product code PJE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PJE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260