FDA Product Code QLU: Anti-factor Xa Activity Test System, Apixaban
A Heparin And Direct Oral Factor Xa Inhibitor Drug Test System Is Intended For The Detection Of Heparin And Direct Oral Factor Xa Inhibitors In Human Specimens Collected From Patients Taking Heparin Or Direct Oral Factor Xa Inhibitors. This Device Is Intended To Aid In The Management Of Therapy In Conjunction With Other Clinical And Laboratory Findings.
Leading manufacturers include Instrumentation Laboratory CO and Siemens Healthcare Diagnostics Products GmbH.
FDA 510(k) Cleared Anti-factor Xa Activity Test System, Apixaban Devices (Product Code QLU)
About Product Code QLU - Regulatory Context
510(k) Submission Activity
3 total 510(k) submissions under product code QLU since 2020, with 2 receiving FDA clearance (average review time: 318 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under QLU have taken an average of 251 days to reach a decision - down from 352 days historically, suggesting improved FDA processing for this classification.
QLU devices are reviewed by the Hematology panel. Browse all Hematology devices →