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AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer (in human plasma) using the Hitachi 911, Hitachi 902, or Hitachi 717 instruments. Laboratory measurements of D-dimer have been shown to be of significance in the assessment of pulmonary embolism, deep vein thrombosis and disseminated intravascular coagulation.

AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer (in human plasma) using the Hitachi 911, Hitachi 902, or Hitachi 717 instruments. AutoDimer Assay utilizes antibody-coated latex particles. The antibody-coated particles are coated with a monoclonal antibody reacting with fibrin D-dimer or fragment D of fibrinogen but not with fibrinogen, allowing D-dimer determination in human plasma.

This FDA 510(k) clearance letter (K012755) for the AutoDimer Assay primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed study information regarding acceptance criteria and performance metrics typically found in a full submission. The provided text is a summary letter, not the full submission itself.

Therefore, I cannot provide the requested information such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, adjudication method, MRMC study details, standalone performance, or training set information.

The document states:

• Device Name: AutoDimer Assay
• Regulation Number: 21 CFR § 864.7320 (Fibrinogen/Fibrin Degradation Products Assay)
• Regulatory Class: II

Indications For Use (as per the document):

"AutoDimer Assay is an immunoturbidimetric assay used for the quantitative determination of the fibrin degradation product D-dimer in human plasma, using the Hitachi 911, Hitachi 902, and Hitachi 904 instruments. AutoDimer Assay utilizes antibody-coated latex particles. The antibodies are coated with a monoclonal antibody reacting with fibrin D-dimer or fragment D of fibrinogen but not with with Fibrinogen, allowing D-dimer determination in human plasma. Laboratory measurements of D-dimer have been shown to be of significance in the assessment of pulmonary embolism, deep venous thrombosis and disseminated intravascular coagulation."

To obtain the detailed study information, one would need to access the full 510(k) submission for K012755, which is not provided in the given text.

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