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510(k) Data Aggregation

    K Number
    K011933
    Device Name
    GLYCOSAL II HBA 1C TEST
    Manufacturer
    PROVALIS DIAGNOSTICS LTD.
    Date Cleared
    2001-11-02

    (135 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GLYCOSAL II HBA 1C TEST

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Glycosal™ II HbA1c test is an affinity chromatography method and is intended for the in-vitro quantitative determination of HbA1c in capillary blood taken from a finger prick. The test is indicated for use by diabetics for monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control. The Glycosal™ II HbA1c test is intended for use as a prescription home use test.

    Device Description

    Instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics.

    AI/ML Overview

    Below is a summary of the acceptance criteria and study information for the Glycosal™ II HbA1c Test, based on the provided text.

    1. Acceptance Criteria and Reported Device Performance:

    The document primarily focuses on obtaining FDA clearance through substantial equivalence to predicate devices (Glycosal™ HbA1c test and Metrika DRX HbA1c) rather than defining specific numerical acceptance criteria for performance. The "reported device performance" would therefore typically involve demonstrating comparable accuracy, precision, and other assay characteristics to these predicate devices. However, explicit numerical acceptance criteria for performance (e.g., specific CV%, bias, correlation coefficients) and their direct fulfillment are not detailed in the provided text. The text indicates the device is an "instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin (GHb) in diabetics," and the intended use is for "monitoring the time averaged blood glucose levels of known diabetics as an indicator of overall glycaemic control."

    Acceptance CriteriaReported Device Performance
    Not explicitly stated in the document as numerical performance goals. The primary "acceptance" was FDA's determination of substantial equivalence to predicate devices, implying comparable safety and effectiveness.Performance data, while likely submitted to FDA for the 510(k), is not detailed in this summary. The device was deemed "substantially equivalent" to predicate devices, meaning its performance was considered comparable for its intended use.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size for Test Set: Not specified in the provided text.
    • Data Provenance: Not specified in the provided text.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

    • Number of Experts: Not specified in the provided text.
    • Qualifications of Experts: Not specified in the provided text.

    4. Adjudication Method for the Test Set:

    • Adjudication Method: Not specified in the provided text.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

    • MRMC Study: No, an MRMC comparative effectiveness study is not mentioned in the provided text. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. The Glycosal™ II HbA1c Test is an in-vitro diagnostic (IVD) quantitative assay, not an imaging interpretation device.

    6. Standalone (Algorithm Only) Performance Study:

    • Standalone Study: The device is described as an "instrument read, single use in vitro test for the quantitative determination of glycated hemoglobin." This implies that the device operates as a standalone system (algorithm/assay only) to provide a quantitative result. Therefore, a standalone performance study, demonstrating the accuracy and precision of the assay in producing the HbA1c value, would have been necessary for the 510(k) submission, even if the details are not explicitly provided in this summary.

    7. Type of Ground Truth Used:

    • Type of Ground Truth: For quantitative in-vitro diagnostics like HbA1c tests, the "ground truth" would typically be established using reference methods or highly accurate, clinically accepted laboratory assays for glycated hemoglobin (HbA1c) on the same blood samples. This is not explicitly stated in the provided text, but it is the standard practice for validating such devices.

    8. Sample Size for the Training Set:

    • Sample Size for Training Set: Not applicable/Not specified in the provided text. This device is an in-vitro diagnostic assay based on affinity chromatography, not an AI/ML algorithm that requires a training set in the conventional sense. Its performance is determined by the biochemical properties of the assay and the calibration of the instrument, not by machine learning from a data set.

    9. How the Ground Truth for the Training Set Was Established:

    • Ground Truth for Training Set: Not applicable as there is no mention of an AI/ML training set as this is an in-vitro diagnostic assay.
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