LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K060570
    Device Name
    HEMOGLOBIN ALC CONTROL
    Manufacturer
    COMPASS BIOSCIENCE
    Date Cleared
    2006-04-13

    (38 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Compass Bioscience Hemoglobin A1c Control is to be used as a quality control material to assess the accuracy and precision of laboratory test methods used to measure Hemoglobin A1c levels. It is intended to validate the measurement of Hemoglobin A1c in patient samples.

    Two levels of control are provided to allow the performance of the analyte test methods to be monitored within the clinically significant range.

    Device Description

    The Compass Bioscience Hemoglobin A1c Control is supplied as frozen liquid in two levels and consists of a human whole blood matrix adjusted to target concentrations of glycated hemoglobin (HbA1c) and containing preservatives and stabilizers. Assayed values are determined from interlaboratory data.

    Hemoglobin A1c Assayed Controls are supplied in two levels, 3 x 1 mL each level per box . The controls are supplied as a ready-to-use frozen liguid, requiring no reconstitution or dilution. They are prepared in a human whole blood matrix adjusted to target concentrations of HbA1c. Stabilizers and preservatives have been added to inhibit microbial growth.

    AI/ML Overview

    This submission describes a Hemoglobin A1c Assayed Control (K060570) and its substantial equivalence to an existing predicate device for quality control in laboratory settings. The performance criteria and testing focus on product stability rather than diagnostic accuracy as the device is a control material, not a diagnostic test.

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

    Acceptance Criteria (Failure Criterion)Reported Device Performance
    Closed Vial Stability (-15°C to -25°C):
    Analate recovery >10% compared to initial value ± highest allowable instrument/reagent imprecision2 years (based on accelerated stability studies; real-time testing ongoing)
    Closed Vial Stability (2-8°C):
    Analate recovery >10% compared to Day 0 value after 35 days of storage at 20-25°C (accelerated testing)12 months (passed stability within ±10% recovery after 35 days at 20-25°C)
    Open Vial Stability (2-8°C):
    Analate recovery >10% compared to Day 0 value after 88 days of storage at 2-8°C90 days (passed stability within ±10% recovery after 88 days at 2-8°C)
    Open Vial Stability (20-25°C):
    Analate recovery >10% compared to Day 0 value after 10 days of storage at 20-25°C7 days (passed stability within ±10% recovery after 10 days at 20-25°C)

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Test Set Sample Size: The document does not specify the exact number of individual samples or vials tested for each stability study. It mentions testing "multiple lots of product" for open vial stability but does not provide a specific number.
    • Data Provenance: The studies are described as "accelerated stability studies" and "real-time stability testing." Given the context of a 510(k) submission to the FDA, it is highly likely these studies were conducted in the US (where Compass Bioscience is based). The studies appear to be prospective, as they involve monitoring the product over time under defined storage conditions.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    This is not applicable to this submission. The device is a quality control material, not a diagnostic device requiring expert interpretation of results. The "ground truth" for the test set (stability studies) is defined by the initial concentration of HbA1c in the control material and its change over time, or by interlaboratory assayed values.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    This is not applicable to this submission as there is no human interpretation or adjudication of performance based on the type of data presented (stability measurements).

    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 is not applicable. The device is a quality control material, not an AI-assisted diagnostic tool.

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

    This is not applicable. The device is a physical control material, not an algorithm.

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

    The "ground truth" for the stability studies is primarily:

    • Initial test value: The concentration of HbA1c in the control material at the start of the stability study (day 0).
    • Interlaboratory data: For assayed values, the ground truth is established collectively from interlaboratory studies using various instrument manufacturers' reagents. This represents a consensus of measured values across different laboratory settings.

    8. The sample size for the training set

    This is not applicable. The device is a quality control material, not a machine learning model that requires a training set.

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

    This is not applicable for the reasons stated in point 8.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1