Anti-Factor Xa Activity Test System, Apixaban
The Anti-Factor Xa Activity Test System, Apixaban is a Class 2 hematology device intended for the detection of heparin and direct oral factor Xa inhibitors (such as apixaban) in human specimens from patients on anticoagulant therapy, used as an aid in the management of anticoagulation therapy in conjunction with other clinical and laboratory findings. It requires 510(k) clearance and is regulated under 21 CFR 864.7295 within the Hematology medical specialty. The product code is QLU. The device is not an implant and is not flagged as life-sustaining.
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Basic Information
- Product Code
- QLU
- Device Class
- FDA class 2
- Regulation Number
- 864.7295
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
Definition
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) | Oct 10, 2024 | Substantially Equivalent | Siemens Healthcare Diagnostics Products GmbH |
| K223187 | HemosIL Liquid Anti-Xa | Jun 23, 2023 | Substantially Equivalent | Instrumentation Laboratory CO |
| DEN190032 | HemosIL Liquid Anti-Xa | Sep 17, 2020 | Unknown | Instrumentation Laboratory CO |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.