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The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay.

The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay.

For in vitro diagnostic use.

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I am sorry. This document is a letter from the FDA regarding the 510(k) premarket notification for the K-Assay D-Dimer Immunoturbidimetric Assay and Calibrator. It primarily discusses regulatory classification and approval to market the device.

Based on the provided text, there is no information available about the acceptance criteria or a study proving the device meets acceptance criteria.

The document details the following:

• Device Name: K-Assay® D-Dimer Immunoturbidimetric Assay and K-Assay® D-Dimer Immunoturbidimetric Calibrator
• Regulation Number: 21 CFR 864.7320
• Regulation Name: Fibrinogen/fibrin degradation products assay
• Regulatory Class: Class II
• Product Code: DAP: GHH
• Indications For Use: The Kamiya K-ASSAY® D-Dimer Assay is an in vitro diagnostic reagent for the quantitative determination of cross-linked fibrin degradation products containing D-Dimer in human plasma or serum by immunoturbidimetric assay. The K-ASSAY® D-Dimer Calibrator Set is an in vitro diagnostic reagent for the calibration of the K-ASSAY® D-Dimer Assay. For in vitro diagnostic use.

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