QXT · Class II · 21 CFR 862.3115

FDA Product Code QXT: Infliximab Test System

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.

Leading manufacturers include Procisedx, Inc..

1
Total
0
Cleared
660d
Avg days
2023
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Infliximab Test System Devices (Product Code QXT)

1 devices
1–1 of 1
Not Cleared Sep 29, 2023
Procise IFX
DEN210056
Procisedx, Inc.
Toxicology · 660d

About Product Code QXT - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code QXT since 2023, with 0 receiving FDA clearance (average review time: 660 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

QXT devices are reviewed by the Toxicology panel. Browse all Toxicology devices →