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The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application is intended for the Hitachi instrument and is to be used by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.

The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The method claimed is an immunological assay. Both the concentration of the HbA1c and the concentration of the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. This test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.

The provided document is a 510(k) summary for a medical device (LIQUI-HEME Glycohemoglobin A1c Assay) and does not contain detailed study information, acceptance criteria, or performance data in the format requested.

Specifically, this document is a regulatory approval letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device. It states the device name, regulation number, regulatory class, and product codes, along with its indications for use.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on regulatory approval, not detailed performance metrics.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not available. This device is an in-vitro diagnostic reagent, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: Not available. The device measures HbA1c, and ground truth would typically be established by a reference method, but details are not provided.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document primarily states that the device is an "In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood" and that "Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus." It also mentions that "This application report has been validated for the Hitachi instrument of clinical chemistry analyzers by suitably qualified personnel under appropriate clinical laboratory conditions." However, the specific data, acceptance criteria, and study details that would back up these statements are not included in this regulatory letter.

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