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510(k) Data Aggregation

    K Number
    K142789
    Device Name
    A1c iGear System
    Manufacturer
    Sakae Corporation
    Date Cleared
    2014-12-16

    (81 days)

    Product Code
    LCP
    Regulation Number
    864.7470
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K130014
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Alc iGear is intended for in vitro diagnostic use only for the quantitative measurement of the percent hemoglobin A1c (%HbA1c) from fingerstick blood or venous whole blood collected in either EDTA or sodium fluoride (NaF) for clinical laboratory and point of care use. The measurement of HbA1c is recommended to monitor long-term glycemic control of persons previously diagnosed with diabetes mellitus. This test is not for screening or diagnosis of diabetes.

    Device Description

    A1c iGear is a fully automated, desktop, electrical spectrophotometer that measures %HbA1c in human whole blood using a dedicated reagent (MEDIDAS HbA1c). The system shines light from a 660 nm light emitting diode (LED) through the test material and measures the percent of hemoglobin A1c in the total hemoglobin (%HbA1c) based on the lot-specific reagent parameters and changes in light absorbency caused by antigen-antibody reactions.

    MEDIDAS HbA1c (the reagent component) is composed of a test cartridge, capillary, pipette tip and master calibration card. The cartridge is pre-filled with the reagent; namely latex (Reagent 1: R1), antibody (Reagent 2: R2), and sample diluent solution. The A1c iGear and MEDIDAS HbA1c assay utilize an immuno-turbidimetric method to determine the percentage of HbA1c in total hemoglobin directly.

    AI/ML Overview

    This document describes the performance of the A1c iGear System, a device for quantitative measurement of percent hemoglobin A1c (%HbA1c).

    Acceptance Criteria and Reported Device Performance

    The acceptance criteria for the A1c iGear System are not explicitly listed as a separate table with specific pass/fail thresholds in the provided document. However, the performance data presented, particularly related to precision and method comparison, implies the acceptance criteria were met given the conclusions stated for each study.

    Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the conclusions:

    Performance MetricInferred Acceptance Criteria (Based on Study Conclusions)Reported Device Performance
    Precision (Internal)All %CVs for repeatability 0.97), linear regression lines nearly Y=X, and very small biases.Site 1 (n=42): Slope 0.95, y-intercept 0.10, R^2 0.99, Bias -0.25
    Site 2 (n=44): Slope 0.95, y-intercept 0.20, R^2 0.99, Bias -0.18
    Site 3 (n=40): Slope 0.94, y-intercept 0.34, R^2 0.97, Bias -0.09
    Limit of Detection (LoD)LoD should be less than the lower end of the analytical range (4.3%) and clinically acceptable.LoB 2.3%, LoD 2.6%
    LinearityR^2 close to 1.00 (e.g., >0.99) and slope close to 1.00.y=0.98x+0.19, r^2=1.00 (across 4.0% to 15.0% HbA1c)
    Matrix ComparisonHigh squared correlation coefficients (R^2 > 0.99) and slopes close to 1.00.Fingerstick vs EDTA (n=78, 4.3-9.0% HbA1c): y=0.96x+0.15, r^2=0.99
    NaF vs. Fingerstick (n=46, 4.8-8.8% HbA1c): y=1.04x-0.06, r^2=0.99
    NaF vs. EDTA (n=81, 5.3-10.9% HbA1c): y=1.01x+0.01, r^2=0.99
    Interference (Common substances)No significant interference observed at relevant concentrations.Bilirubin (unconjugated 37 mg/dL, conjugated 40.4 mg/dL), Triglycerides (2000 mg/dL), Rheumatoid Factor (550 IU/mL), Acetaminophen (20 mg/dL), Ibuprofen (50 mg/dL), Glibenclamide (0.2 mg/dL), Metformin (5.1 mg/dL), Ascorbic Acid (6.0 mg/dL) showed no significant interference.
    Interference (Labile, Carbamylated, Acetylated Hb)No significant interference observed.No significant interference with D-glucose (up to 2000 mg/dL), sodium cyanate (up to 10 mg/dL), acetylsalicylic acid (up to 200 mg/dL).
    Interference (Hemoglobin Variants)Device performance should be characterized, and labeling should reflect any interferences.Hemoglobin C increased results by 24%, Hemoglobin D by 16%, Hemoglobin E by 13%, Hemoglobin S by 14%. Hemoglobin F (>10%) decreased results by 32%. A boxed warning is included in the labeling.

    Study Information

    The document describes several studies conducted to demonstrate the performance of the A1c iGear System. Note that the A1c iGear System is stated to be a modified version of the previously cleared A1c GEAR System (K130014), and some performance data (Limit of Detection, Linearity, Matrix Comparison, Interference/Analytical Specificity) were generated with the A1c GEAR analyzer and repeated for completeness.

    1. Precision Studies (Internal and External)

    • Sample Size:
      • Internal Precision:
        • Control Material: 3 levels, each tested in duplicate for 10 days on each of two A1c iGear instruments. Total 40 results per control level.
        • Whole Blood Samples: 3 levels, each tested in duplicate for 10 days on each of two A1c iGear instruments. Total 40 results per sample level.
      • External Precision (Controls): 3-level control set, tested in duplicate for 20 days by each of three different operators at three separate sites. Total N=360 per control level.
      • External Precision (Whole Blood): 3 whole blood samples (low, middle, high %HbA1c) tested two tests per day for 10 days by three operators at three separate sites. Total N=360 per whole blood sample.
    • Data Provenance: The internal precision study likely occurred at the manufacturer's facility. The external precision study was conducted at "three external POC sites" for the A1c iGear System. The data generated is prospective for the A1c iGear system.
    • Number of Experts/Ground Truth: Not applicable for precision studies, as these evaluate the device's consistency, not accuracy against a true value.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No. This section describes device precision (reproducibility and repeatability).
    • Standalone Performance: Yes, this describes the standalone performance of the A1c iGear System.
    • Type of Ground Truth: Not applicable for precision studies.
    • Training Set Sample Size/Ground Truth: Not specified/applicable, as this describes a performance validation study, not an AI model.

    2. Method Comparison Study (Accuracy)

    • Sample Size:
      • Site 1: 42 patient samples
      • Site 2: 44 patient samples
      • Site 3: 40 patient samples
      • Total: 126 patient samples
    • Data Provenance: Patient samples (both fingerstick and venous whole blood) were collected at "three external POC sites" and compared against a reference laboratory. This is prospective data originating from these POC sites.
    • Number of Experts/Ground Truth: Not applicable in the typical sense of expert review for imaging data. The ground truth (reference method) was High-Performance Liquid Chromatography (HPLC) testing performed at a reference laboratory.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No. This compares the device to a reference method, not human readers.
    • Standalone Performance: Yes, this describes the standalone performance of the A1c iGear System against a reference method.
    • Type of Ground Truth: Reference method (HPLC).
    • Training Set Sample Size/Ground Truth: Not specified/applicable.

    3. Limit of Detection (LoD)

    • Sample Size:
      • LoB: 90 replicates of a zero sample (blank)
      • LoD: 27 replicates of three low HbA1c samples
    • Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), which is the predicate device. Therefore, the provenance is likely internal testing by the manufacturer.
    • Number of Experts/Ground Truth: Not applicable.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No.
    • Standalone Performance: Yes.
    • Type of Ground Truth: Controlled samples (blank, low HbA1c samples).
    • Training Set Sample Size/Ground Truth: Not specified/applicable.

    4. Linearity

    • Sample Size: Two EDTA whole blood samples (normal and elevated HbA1c) were inter-mixed to make 11 intermediate samples. All intermediate dilutions were analyzed in replicates of three.
    • Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), which is the predicate device. Likely internal testing by the manufacturer.
    • Number of Experts/Ground Truth: Not applicable.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No.
    • Standalone Performance: Yes.
    • Type of Ground Truth: Serially diluted samples (prepared from known normal and high HbA1c blood).
    • Training Set Sample Size/Ground Truth: Not specified/applicable.

    5. Matrix Comparison

    • Sample Size:
      • Fingerstick vs EDTA: 78 donor samples (Site 1)
      • NaF vs. Fingerstick: 46 donor samples (Site 2)
      • NaF vs. EDTA: 81 donor samples (Site 3)
      • Total: 205 donor samples.
    • Data Provenance: This data was generated with the A1c GEAR analyzer (K130014), the predicate device. Donor samples were collected from three different sites. This is retrospective data relative to the A1c iGear, but prospective for the original A1c GEAR validation.
    • Number of Experts/Ground Truth: Not applicable.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No.
    • Standalone Performance: Yes.
    • Type of Ground Truth: Comparative analysis between different sample matrices (Fingerstick, EDTA whole blood, NaF whole blood) measured by the device.
    • Training Set Sample Size/Ground Truth: Not specified/applicable.

    6. Interference and Analytical Specificity (Variant Hemoglobins)

    • Sample Size:
      • Common Interferents: Human EDTA and NaF whole blood samples with different %HbA1c levels (~6.3% and ≥9.0% HbA1c values) spiked with interferents, tested in quadruplicate. Specific number of samples not given for each interferent.
      • Labile, Carbamylated, Acetylated Hb: EDTA and NaF whole blood samples with different %HbA1c levels (~6.3% and > 9.0% HbA1c) incubated with the substance, analyzed for a total of four replicates per sample.
      • Hemoglobin Variants: Commercial samples known to contain Hemoglobin C, D, E, S, and F (at concentrations from 4.6-11.6% HbA1c) tested in duplicate. Specific number of samples not given for each variant.
    • Data Provenance: This data was generated with the A1c GEAR System (K130014), the predicate device. Likely internal laboratory testing.
    • Number of Experts/Ground Truth: Not applicable.
    • Adjudication Method: Not applicable.
    • MRMC Comparative Effectiveness Study: No.
    • Standalone Performance: Yes.
    • Type of Ground Truth: Controlled samples (spiked with known interferents/variants) measured by the device and compared to reference samples (without interferent).
    • Training Set Sample Size/Ground Truth: Not specified/applicable.

    Note: No information regarding AI or machine learning algorithms, training sets, or expert adjudication for ground truth (beyond using laboratory reference methods) is provided in this document as it pertains to a medical device for quantitative measurement rather than an AI/ML diagnostic software. The questions concerning "Number of experts," "Adjudication method," and "MRMC comparative effectiveness study" are typically relevant for AI/ML-based diagnostic devices. This submission does not describe such a device.

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