510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN210056Unknown

Procise IFX

Procisedx, Inc., San Diego CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN210056 is the FDA 510(k) clearance record for Procise IFX, a class II device, cleared for Procisedx, Inc. on under FDA product code QXT (Infliximab Test System). FDA's definition for product code QXT reads: "An infliximab test system intended for the measurement of an infliximab as an aid in the management of patients with Crohn’s disease or ulcerative colitis". FDA records list 2 510(k) clearances for Procisedx, Inc. As of , FDA records show no recalls naming DEN210056.

Clearance record

Decision date
Received
(660 days to decision)
Product code
QXT Infliximab Test System
Regulation
21 CFR 862.3115
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Procisedx, Inc. 9449 Carroll Park Dr., San Diego CA
Third party review
No

Clearances, product code QXT

Trailing 12 months

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

FDA records show no clearances under product code QXT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QXT, 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