FDA 510K for Multipurpose System for In Vitro Coagulation Studies
A laboratory device analyzes blood clotting by performing multiple tests on a single blood sample, typically using citrated plasma. This allows healthcare professionals to assess a patient’s bleeding or clotting tendencies comprehensively. Features include automated sample handling, reagent mixing, incubation, and detection capabilities. The system measures parameters like Prothrombin Time, Activated Partial Thromboplastin Time, Fibrinogen levels, and specialized coagulation factors, providing a comprehensive picture of a patient’s coagulation status.
Intended Use of Multipurpose System for In Vitro Coagulation Studies
A Multipurpose System for In Vitro Coagulation Studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
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 Multipurpose System for In Vitro Coagulation Studies
FDA 510K for Multipurpose System for In Vitro Coagulation Studies Device Code and Regulation Number
System, Multipurpose For In Vitro Coagulation Studies
Intended Use:
The Haemostasis System includes the Analyzer and the Citrated: K, KH, RTH, FFH assay cartridge for in vitro diagnostic use in adults to evaluate blood haemostasis. It analyzes 3.2% citrated whole blood as it clots, providing semi-quantitative results. The system is applicable in labs or at the point-of-care, especially for patients at higher risk of coagulopathy due to heparin. Evaluations help assess conditions in cardiovascular surgeries and liver transplants related to bleeding or clotting.
The cartridge features four assays: CK -Citrated Kaolin, CKH- Citrated Kaolin with Heparinase, CRTH- Citrated Rapider (CRT), and CFFH- Citrated Functional Fibrinogen. The CK assay measures haemostasis via the intrinsic pathway, focusing on R (clotting time) and MA (maximum clot strength). CKH evaluates heparin effects by comparing results with CK. CRTH examines both intrinsic and extrinsic pathways, offering a faster MA result. CFFH assesses haemostasis while blocking platelet effects, reporting MA and functional fibrinogen levels. Results should be used alongside medical history and additional tests for diagnosis, with applications in cardiovascular procedures to monitor bleeding and thrombosis risks.
Device Description:
It records kinetic changes in whole blood as it clots, retracts, or lyses, providing clinicians with numerical values and graphs to determine clotting dysfunction or coagulopathy. The system uses a disposable Assay Cartridge, blood, or Quality Control material, and metered into multiple analysis channels. The system also reconstitutes reagents and monitors viscoelastic changes due to coagulation.
Plasma, Coagulation Control
Intended Use:
Use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte: D-Dimer in a clinical laboratory setting by laboratory personnel. The product is intended for use with quantitative assays on the indicated analysers specified in the labeling.
Device Description:
The Linearity Test Kit is a human plasma base matrix containing one set of D-Dimer analyte and five liquid levels, each of 3.0 mL. It aims to establish the relationship between theoretical and actual performance of the analyte, using human-origin material tested at the donor level.
Performance Testing (Analytical) for Multipurpose System for In Vitro Coagulation Studies
- Stability Studies
- Precision/Reproducibility
- Linearity/assay reportable range
- Traceability (controls, calibrators, or method)
- Recovery study
- Analytical Specificity (Cross Reactivity
Clinical Testing:
No Guidance available for 510k submission