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Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.

Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.

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The provided text is a 510(k) premarket notification letter from the FDA to Diazyme Laboratories for their Homocysteine 2 Reagent Enzymatic Assay. This document does not contain the detailed study information needed to describe acceptance criteria and device performance in the requested format.

The letter acknowledges the submission and states that the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulation name, regulatory class, and product code. It also includes the "Indications for Use" for the device, which describes what the assay is intended to do (quantitative determination of total L-homocysteine in serum or plasma) and for whom (assisting in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria, including those on certain medications).

However, the document does not provide any specific information regarding:

• Acceptance criteria values or reported device performance metrics. These would typically include sensitivity, specificity, accuracy, precision, etc., with numerical targets and achieved results.
• Study design details:
  • Sample size for the test set or training set.
  • Data provenance (country of origin, retrospective/prospective).
  • Number or qualifications of experts for ground truth.
  • Adjudication methods.
  • Whether MRMC or standalone studies were performed, or any corresponding effect sizes.
  • Type of ground truth used (e.g., pathology, outcomes data).
  • How ground truth for the training set was established.

Therefore, I cannot fulfill the request by extracting the specific information about acceptance criteria and study details from the provided text. This document is a regulatory approval letter, not a technical study report.

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