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    K Number
    K182428
    Device Name
    GlucoLeader Enhance Blood Glucose Monitoring System
    Manufacturer
    HMD BioMedical Inc.
    Date Cleared
    2019-05-08

    (244 days)

    Product Code
    NBW
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K032985
    Predicate For
    K212248
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The GlucoLeader Enhance Blood Glucose Monitoring System is comprised of GlucoLeader Enhance Blood Glucose Meter and GlucoLeader Enhance Blood Glucose Test Strips.

    The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The GlucoLeader Enhance Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. It is intended for selftesting outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GlucoLeader Enhance Blood Glucose Monitoring System should not be used for the diagnosis of or screening for diabetes. GlucoLeader Enhance Blood Glucose Monitoring System is not for use in neonates.

    Device Description

    The GlucoLeader Enhance Blood Glucose Monitoring System is designed to pursuit the accuracy in blood glucose monitoring to provide you with easy and comfortable testing. The GlucoLeader Enhance Blood Glucose Monitoring System mainly consists of four parts as below,

    1. GlucoLeader Enhance Blood Glucose Meter

    2. GlucoLeader Enhance Blood Glucose Test Strips*

    3. GlucoLeader Enhance Glucose Control Solutions (L1-Low glucose level, L2-High glucose level)*

    4. GlucoLeader Enhance Check Strip*.

    *These products are intended to be used together to get accurate blood glucose test results. They are not included in the kit package, and should be purchased separately.

    The meter display screen size of 1.73" x 1.7" is large and easy-to-read, and the meter weight of 0.122 lbs. (55.2 grams) is lightweight and portable for your convenience. The GlucoLeader Enhance Blood Glucose Monitoring System is traceable to the NIST (SRM) 917A. The GlucoLeader Enhance Glucose Control Solutions have L1 and L2 levels for optional purchasing, and L1 is low glucose level and L2 is high glucose level.

    The GlucoLeader Enhance Blood Glucose Meter has the latest technology for blood glucose monitoring and is made with quality components. The GlucoLeader Enhance Blood Glucose Test Strips have been updated with Glucose dehydrogenase-FAD Enzyme, which not only improves the accuracy of measurements, but also increases the HCT interference range up to 10-70%. Also, the required test blood sample volume is reduced to 0.8 µL, and the test reaction time is only 5 seconds.

    If your GlucoLeader Enhance Blood Glucose Meter is being operated by a second person who is providing testing assistance to the user. the meter and lancing device should be disinfected prior to use by the second person. Consult your healthcare professional if unusual readings occur.

    AI/ML Overview

    The GlucocLeader Enhance Blood Glucose Monitoring System is a medical device for quantitative measurement of glucose in fresh capillary whole blood samples. It is intended for self-testing by people with diabetes at home.

    Here's an analysis of its acceptance criteria and study data:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance CriteriaReported Device Performance
    Accuracy (User Performance)"The GlucoLeader Enhance blood glucose meter gave results within 15% of their true blood glucose level 351 out of 360 times." (This implies a requirement for at least 97.5% of readings to be within ±15%.)Within ±5%: 59.7% (215/360) Within ±10%: 84.7% (305/360) Within ±15%: 97.5% (351/360) Within ±20%: 100% (360/360)
    System Accuracy at Extreme Glucose Values (< 75 mg/dL)More than 95% of individual bias fell within ±15 mg/dL.Within ±5 mg/dL: 64.7% (97/150) Within ±10 mg/dL: 93.3% (140/150) Within ±15 mg/dL: 98.7% (148/150) Within ±20 mg/dL: 100% (150/150) (All Lots combined for glucose concentrations < 80 mg/dL, which is slightly different but still relevant.)
    System Accuracy at Extreme Glucose Values (≥ 75 mg/dL)More than 95% of individual bias fell within ±15%.Within ±5%: 67.3% (101/150) Within ±10%: 84.7% (127/150) Within ±15%: 97.3% (146/150) Within ±20%: 100% (150/150) (All Lots combined for glucose concentrations > 250 mg/dL, which represents a high glucose extreme, not necessarily the entire range ≥ 75 mg/dL, but confirms performance at high values.)
    Within-Run PrecisionCV within 5% at glucose concentration ≥ 100 mg/dL, and SD within 5 mg/dL at glucose concentration < 100 mg/dL (American Diabetes Association acceptance criteria).Glucose Level 1 (43.2 mg/dL): Combined SD 2.1 mg/dL (meets < 5 mg/dL) Glucose Level 2 (80.7 mg/dL): Combined SD 2.9 mg/dL (meets < 5 mg/dL) Glucose Level 3 (138.3 mg/dL): Combined CV 3.3% (meets < 5%) Glucose Level 4 (178.5 mg/dL): Combined CV 3.6% (meets < 5%) Glucose Level 5 (278.3 mg/dL): Combined CV 4.0% (meets < 5%)
    Intermediate Precision (Day-to-Day)CV of glucose devices < 5% when concentration ≥ 100 mg/dL, and SD < 5 mg/dL when concentration < 100 mg/dL.Glucose Level 1 (45.0 mg/dL): Combined SD 1.2 mg/dL (meets < 5 mg/dL) Glucose Level 2 (80.0 mg/dL): Combined SD 2.1 mg/dL (meets < 5 mg/dL) Glucose Level 3 (125.0 mg/dL): Combined CV 2.1% (meets < 5%) Glucose Level 4 (200.0 mg/dL): Combined CV 1.7% (meets < 5%) Glucose Level 5 (300.0 mg/dL): Combined CV 1.9% (meets < 5%)
    Hematocrit InterferenceGlucose differences within ±8% and no individual value differences ±15% relative to the YSI at HCT levels from 10% to 70% when glucose concentrations are ≥ 75 mg/dL. Glucose differences within ±15 mg/dL when glucose concentrations are < 75 mg/dL.Verdict "Accept" for HCT levels from 10% to 70%.
    Altitude StudyBias and bias% of five glucose measures at each altitude level (sea level to 10,000 feet) within ±10 %.No significant effect on glucose measurements; bias and bias% within acceptance criteria.
    LinearityNot explicitly stated, but the result should demonstrate linear correlation.Correlation coefficient is 1.00. Linearity range is 10 - 600 mg/dL.
    Stressed Operating Temperature and HumidityBias < 10 mg/dL for glucose < 100 mg/dL and Bias < 10 % for glucose ≥ 100 mg/dL. Operating conditions: 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.Test results meet acceptance criteria. The system can be operated normally under 50-104 °F (10 ~ 40 °C), 10 ~ 90% RH.
    Cleaning & Disinfection RobustnessCapable for 18,250 times of cleanings and disinfections (mimicking 10 times/day for 5 years), with no damaging and readable logo/labels, and proper performance/functionality.Device capable for 18,250 times; no damage, readable logo/labels, and worked properly with stimulated test strip.
    Sample Perturbation Study(Implicitly that perturbation should not significantly affect precise blood glucose measurement).No significant effect on precise blood glucose measurement.
    Sample Volume Evaluation(Implicitly that the device should indicate an error if insufficient sample volume, and perform accurately with sufficient volume). Minimum sample volume of 0.8 µL for accurate measurements.0.8 µL is the minimum; if less, error code E42 is displayed.
    Interference Substances Evaluation(Implicitly, the device should perform accurately in the presence of common interfering substances up to specified concentrations).Highest concentration tested at which no significant interference was summarized. Some substances (e.g., Acetaminophen, high bilirubin, hemoglobin, maltose, triglycerides) may cause slightly higher results at high concentrations.
    Shelf Life (Test Strips - Unopened Vial)24 monthsValidated and claimed to be 24 months.
    Shelf Life (Test Strips - Opened Vial)90 daysClaimed to be 90 days.
    Shelf Life (Control Solution - Unopened Vial)18 monthsValidated and claimed to be 18 months.
    Shelf Life (Control Solution - Opened Vial)90 daysClaimed to be 90 days.

    2. Sample Sizes and Data Provenance

    • User Performance Clinical Evaluation:
      • Test Set Sample Size: 360 typical users.
      • Data Provenance: The document does not specify the country of origin, but the submitting company is HMD BioMedical Inc. based in Taiwan. The study is described as a "User performance evaluation" and "clinical evaluation," implying prospective data collection with human participants.
    • System Accuracy Evaluation at Extreme Glucose Values:
      • Test Set Sample Size: 100 subjects.
      • Data Provenance: The document does not specify the country of origin. This also appears to be prospectively collected clinical data from human subjects.
    • Within-run precision evaluation: 100 samples (for Lot 1, and presumably for Lots 2 and 3 as well, making it 300 samples total across lots). Data provenance is not specified beyond being laboratory-generated.
    • Intermediate precision (day-to-day) evaluation: Number of samples not explicitly stated per lot, but given the structure, it likely involves multiple measurements over several days across different glucose levels and lots. Data provenance is not specified beyond being laboratory-generated.
    • Other studies (Altitude, Hematocrit, Interference, etc.): Sample sizes are generally not explicitly quantified beyond statements like "five glucose measures at each attitude level" or "3 different levels of glucose concentrations" with "26 endogenous and exogenous substances." These are typically laboratory-based tests.

    3. Number of Experts and Qualifications for Ground Truth

    • No information provided: The document does not mention the number of experts or their qualifications used to establish ground truth for any of the studies.
    • Implied Standard Reference Method: The ground truth for glucose measurements (e.g., in user performance and system accuracy studies) is consistently compared against a "YSI 2300." The YSI 2300 STAT Plus Glucose & Lactate Analyzer is a laboratory reference method widely accepted for accurate glucose measurement. This suggests that the ground truth is established by a highly accurate laboratory instrument, not human experts in the traditional sense of image interpretation.

    4. Adjudication Method for the Test Set

    • None applicable: For glucose monitoring systems, ground truth is established by a reference laboratory instrument (YSI 2300). There is no "adjudication" between human readers or experts as there would be for image interpretation tasks. The comparison is directly between the device's reading and the YSI's reading.

    5. MRMC Comparative Effectiveness Study

    • Not Applicable: This type of study (Multi-Reader Multi-Case comparative effectiveness, assessing human reader improvement with/without AI assistance) is typically relevant for interpretative medical tasks (e.g., radiology AI). The GlucoLeader Enhance is a direct measurement device, not an AI or interpretive tool that assists human readers. Therefore, no such study was conducted or is relevant.

    6. Standalone Performance

    • Yes, standalone performance was done: All listed performance studies (User performance, System Accuracy, Precision, Linearity, Hematocrit, Interference, etc.) evaluate the algorithm/device's performance directly against a reference method (YSI 2300) without human intervention in the measurement interpretation itself. The "User performance clinical evaluation" assesses how typical users operate the device and obtain results, but the accuracy assessment is still the device's output versus the reference.

    7. Type of Ground Truth Used

    • Reference Laboratory Method / Expert Instrument: The ground truth for glucose concentration measurements is established using the YSI 2300 (likely the YSI 2300 STAT Plus Glucose & Lactate Analyzer), which is a highly accurate and widely accepted laboratory reference instrument for glucose measurement. This falls under the category of a "reference standard" or "expert instrument" rather than direct human expert consensus or pathology data.

    8. Sample Size for the Training Set

    • Not applicable / Not explicitly stated: For a traditional medical device like a blood glucose monitor, there isn't typically a "training set" in the machine learning sense. The device's performance is based on its electrochemical methodology and calibration, not on a machine learning model trained on a dataset. The document does not provide details on development or calibration data, which might be analogous to a training set for machine learning devices, but it's not discussed in those terms.

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

    • Not applicable: As explained above, for this type of device, a "training set" in the machine learning context is not relevant. The device is calibrated during manufacturing using reference standards, but detailed procedures for this are not part of the regulatory submission about performance testing.
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