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The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma. The test is intended for use as an aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis and pulmonary embolism.

The Simplify D-dimer test is a rapid immunochromatography test for the qualitative detection of D-dimer (fibrin degradation products containing the cross-linked Ddimer site) in human whole blood and plasma.

While the provided text indicates that the Simplify D-dimer device received 510(k) clearance (K993276) from the FDA, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a clearance letter, stating that the device is substantially equivalent to a legally marketed predicate device for its stated indications for use (aid in the diagnosis of disseminated intravascular coagulation, deep vein thrombosis, and pulmonary embolism). It outlines regulatory responsibilities and contacts, but does not include the technical details of the performance study that would have supported the substantial equivalence claim.

Therefore, I cannot provide the requested information based solely on the provided input. To answer your questions, I would need access to the actual 510(k) submission summary or other detailed performance study reports for the Simplify D-dimer device.

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