FDA 510K for Coagulation Instrument
A Coagulation Instrument is a medical device used to measure the clotting ability of blood. It assesses various aspects of the blood clotting process, such as how long it takes for blood to form a clot and helps diagnose bleeding disorders or monitor patients on blood-thinning treatments.
Intended Use of Coagulation Instrument
A Coagulation Instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
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 Coagulation Instrument
FDA 510K for Coagulation Instrument Device Code and Regulation Number
Instrument, Coagulation, Automated
Intended Use
It is a bench top, fully automated, random-access analysers designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis measurements and calculated parameters.
Device Description
It is a fully Automated Coagulation analysers that utilize the intuitive software, the consumables, reagents, calibrators and controls, and provide the analytical methodology for routine and specialty assay result reporting. The instrument performs the following types of tests, using the optical measuring wavelengths and test parameters:
- Coagulometric (Turbidimetric) Measurements
- Chromogenic (Absorbance) Measurements
- Immunological Measurements
It has pre‐analytical features that alert the instrument operator to a potential HIL (Haemoglobin, Icteric and Lipemia) interference situation specific to the assays requested for a sample, underfilled sample tubes or a detected clog.
Instrument, Coagulation
Intended Use
It is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.
Device Description
It is a photo-optical device used for in-vitro diagnostic clotting and chromogenic tests in clinical labs. It uses light-based methods for both types of assays. The device is powered by a halogen lamp and features an incubator block that maintains a temperature. This block includes four measuring positions, multiple reagent positions and cuvette prewarming slots.
Performance Testing (Analytical Nonclinical) for Coagulation Instrument
- Precision / Reproducibility
- Method comparison (Accuracy instrument)
- Main system verification:
- Thermal verification
- Optical stray light verification
- Environmental verification
- Electrical safety and Electromagnetic compatibility
- Software verification and validation study
Clinical Testing:
No Guidance available for 510k submission