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.
3
Total
2
Cleared
318d
Avg days
2020
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Anti-factor Xa Activity Test System, Apixaban Devices (Product Code QLU)
3 devices
Cleared
Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
Siemens Healthcare Diagnostics Products GmbH
Hematology
251d
Cleared
Jun 23, 2023
HemosIL Liquid Anti-Xa
Instrumentation Laboratory CO
Hematology
254d
Not Cleared
Sep 17, 2020
HemosIL Liquid Anti-Xa
Instrumentation Laboratory CO
Hematology
450d
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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.