(63 days)
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma calibrator that is suitable for use as calibrator for the Sigma Diagnostics AUTO D-Dimer kit Procedure CRS126 for the quantitative determination of fibrin degradation products containing Ddimer in citrated human plasma in D-dimer agglutination assays.
Sigma Diagnostics AUTO D-Dimer Calibrator is a human plasma control that is suitable for use as a calibrator in the Sigma Diagnostics AUTO D-dimer assay. Sigma Diagnostics AUTO D-Dimer Calibrator is a lyophilized human plasma based product. After reconstitution with water, AUTO D-Dimer Calibrator is stable for 3 days when stored at 2-8°C and 8 hours when stored at 18-26°C.
The provided text describes a 510(k) summary for the Sigma Diagnostics AUTO D-Dimer Calibrator. It states that the safety and effectiveness of this new calibrator were demonstrated by its substantial equivalence to a previously marketed calibrator (Sigma Diagnostics AUTO D-Dimer Calibrator, Cat. No. A4842, K003267).
However, the document does not provide specific acceptance criteria, a detailed study report with performance metrics, or information about sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies. The 510(k) summary focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone performance study with explicit acceptance criteria and results.
Therefore, I cannot populate the requested table and answer many of the questions based solely on the given text. The text essentially states "it's equivalent to the old one" without detailing the performance data.
§ 864.7320 Fibrinogen/fibrin degradation products assay.
(a)
Identification. A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).(b)
Classification. Class II (performance standards).