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The Diazyme Homocysteine Enzymatic Assay is intended for the in vitro quantitative determination of total L-homocysteine in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

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I am sorry, but after reviewing the provided document, I cannot find the specific information required to complete the table and answer all the questions regarding the acceptance criteria, study details, and ground truth establishment for the Diazyme Homocysteine Enzymatic Assay.

The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. While it mentions the "Indications for Use," it does not provide details about:

• Specific acceptance criteria values.
• The study design, results, or device performance against those criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details about experts, adjudication methods, or ground truth establishment.
• Information on MRMC studies or standalone algorithm performance.

Therefore, I cannot extract the requested information from this document.

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Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria.

Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.

Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Diazyme Homocysteine Enzymatic Assay Kit. This type of document does not typically contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would be found in a clinical study report or a more comprehensive submission document.

510(k) clearances establish substantial equivalence to a legally marketed predicate device, and while performance data is submitted, the letter itself is a summary of the FDA's decision, not the full study report.

Therefore,Based on the provided text, it is not possible to extract the requested information regarding acceptance criteria and the study details. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a predicate device but does not include the detailed performance study methodology, acceptance criteria, or results.

To answer your questions, one would need to refer to the actual 510(k) submission document (Premarket Notification) submitted by Diazyme Laboratories to the FDA, which would contain the study protocols and results used to demonstrate substantial equivalence.

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