| Device |
anti-factor xa activity test system, apixaban |
| Regulation Description |
Heparin and direct oral factor Xa inhibitor drug test system. |
| 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. |
| Physical State |
Anti-factor Xa activity test system containing reagents, drug-specific calibrators and controls |
| Technical Method |
The test detects residual factor Xa using a chromogenic substrate. The signal or optical density is compared to a drug-specific calibration curve and results are reported as nanograms per milliliter (ng/mL). The test may utilize other technologies and/or detection methods. |
| Target Area |
Peripheral human whole blood (citrated plasma) |
| Regulation Medical Specialty |
Hematology |
| Review Panel |
Hematology |
|---|
| Product Code | QLU |
|---|
| Premarket Review |
Division of Immunology and Hematology Devices
(DIHD)
Division of Immunology and Hematology Devices
(DIHD)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
864.7295
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
