Heparin and Direct Oral Factor Xa Inhibitor Drug Test System

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I3CGlobal IVDR, FDA 510k

FDA 510K for Heparin and Direct Oral Factor Xa Inhibitor Drug Test System

The Heparin and Direct Oral Factor Xa Inhibitor Drug Test System is an in vitro diagnostic device designed to quantitatively assess the activity of heparin and direct oral factor Xa inhibitors (such as apixaban, rivaroxaban, and edoxaban) in patient samples. It is used to determine the concentration of heparin and direct oral anticoagulants (DOACs) in plasma or serum samples, typically employing chromogenic assays, immunoassays, or other techniques that enable detection of these substances in the bloodstream.

Intended Use of Heparin and Direct Oral Factor Xa Inhibitor Drug Test System

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.

For a detailed proposal with a Statement of Work, please complete the Request for Quote (RFQ) form provided separately for FDA 510(k) and IVDR CE Marking for Heparin and Direct Oral Factor Xa Inhibitor Drug Test System
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FDA 510K for Heparin and Direct Oral Factor Xa Inhibitor Drug Test System Device Code and Regulation Number

Sr.

No.

 Product

Code

 Device Regulation

 Description

 Regulation

 Number

 Device Class
1 QLU Anti-Factor Xa Activity Test System, Apixaban Heparin And Direct Oral Factor Xa Inhibitor Drug Test System 21 CFR 864.7295 2

Heparin And Direct Oral Factor Xa Inhibitor Drug Test System

Intended Use:

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.

Device Description:

 It is a one-stage chromogenic test that measures Xa activity using a chromogenic substrate. In heparin-containing samples, the formation of para nitroaniline is reduced due to Xa inhibition by the heparin/antithrombin complex. The assay quantifies heparin activity based on this inhibition, with interference minimized by dextran sulfate. For apixaban-containing samples, the assay measures inhibitor concentration by comparing it to an apixaban-specific reference curve.

The device is an Anti-factor Xa activity test system containing reagents, drug-specific calibrators, and controls, utilizing a chromogenic substrate to detect residual factor Xa, with results reported in nanograms per milliliter (ng/mL) by comparing the signal or optical density to a drug-specific calibration curve, and is designed for use with peripheral human whole blood (citrated plasma), potentially utilizing other technologies and detection methods.

Performance Testing (Analytical) for Heparin and Direct Oral Factor Xa Inhibitor Drug Test System

  • Precision (Reproducibility and Repeatability)
  • Interfering Endogenous and Exogenous Substances
  • Specimen stability
  • Traceability
  • Linearity
  • In-Use Stability and Shelf-life
  • Measuring Interval
  • Limit of Blank (LoB), Limit of Detection (LoD), and Limit of Quantitation (LoQ)

Clinical Testing:

No Guidance available for 510k submission

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