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Teco Hemoglobin A1c Calibrators are for calibrating results in the quantitative determination of human hemoglobin A1c (HbArt) and Teco Hemoglobin Controls are for the purpose of monitoring accuracy and precision in the quantitative determination of human hemogiobin A1c (HbAn). Teco Hemogiobin A1c Reagent set is for the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.

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The provided document is a 510(k) premarket notification letter for a Hemoglobin A1c Reagent Set, Calibrators, and Controls. It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the document does not contain the detailed study information required to answer the questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or reader studies. It is a regulatory clearance letter, not a scientific study report.

Therefore, I cannot provide the requested information from the given text.

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This product is to be used for the quantitative determination of hemoglobin A1c in human blood. The determination of hemoglobin A1c is most commonly performed for the evaluation of glycemic control in diabetes. Hemoglobin A1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher hemoglobin A1c value indicates poorer glycemic control. This reagent set is intended for in vitro diagnostic use only.

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The provided text is a 510(k) clearance letter from the FDA for a Hemoglobin A1c Reagent Set. It primarily confirms that the device is substantially equivalent to a legally marketed predicate device. This type of document does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement.

The FDA 510(k) clearance process relies on demonstrating substantial equivalence, often by comparing the new device's performance to an already cleared predicate device. The specific performance data and studies used to establish this equivalence are typically found in the full 510(k) submission, which is not publicly available in this extract.

Therefore, many of your questions cannot be answered from the provided text.

Here's what can be inferred or stated about the lack of information:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not specified in the provided document. The 510(k) focused on "substantial equivalence" to a predicate device, implying the predicate's performance served as the benchmark.
• Reported Device Performance: Not detailed in the provided document.

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not mentioned.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set

• Adjudication Method: Not mentioned.

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

• This device is a reagent set for a laboratory test, not an AI-powered diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• This is a reagent set, not an algorithm. The concept of "standalone algorithm performance" is not applicable. The device's performance would be evaluated in a laboratory setting, likely against reference methods or established predicate devices.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For a diagnostic reagent set like Hemoglobin A1c, ground truth would typically be established by a reference method for HbA1c measurement, or possibly correlation with patient clinical status/outcomes (though the latter is less direct for a single assay validation). The specific ground truth method used is not detailed in the provided document.

8. The sample size for the training set

• For a reagent set, the concept of a "training set" as it applies to machine learning algorithms is not directly applicable. Performance validation relies on clinical sample testing and analytical studies rather than algorithm training. Any "training" would pertain to optimizing reagent formulations or assay parameters, not a data set for an AI model.

9. How the ground truth for the training set was established

• See answer to #8. Not applicable in the context of AI development.

In summary, the provided FDA 510(k) clearance letter confirms regulatory approval based on "substantial equivalence" but does not offer the detailed technical and clinical study information needed to address your specific questions about acceptance criteria, performance metrics, and study methodology. This information would typically be found in the comprehensive 510(k) submission document itself, which is not included here.

Ask a specific question about this device