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510(k) Data Aggregation

    K Number
    K162822
    Device Name
    ADAMS A1c HA-8180V, CALIBRATOR 80
    Manufacturer
    Arkray Factory, Inc.
    Date Cleared
    2017-06-29

    (265 days)

    Product Code
    PDJ,JIT,LCP
    Regulation Number
    862.1373
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K131580,K071132
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ADAMS A1c HA-8180V system is intended for the quantitative determination of hemoglobin A1c (IFCC mmol/mol and NGSP %) in human whole blood and hemolysate samples using Ion Exchange high performance liquid chromatography (HPLC).

    Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The ADAMS A1c HA-8180V is intended for Professional Use Only.

    The CALIBRATOR 80 is for the calibration of the ADAMS A1c HA-8180V system used for the quantitative determination of hemoglobin A1c in human whole blood and hemolysate samples.

    For In Vitro Diagnostic Use Only.

    Device Description

    The ADAMS A1c HA-8180V system is a fully automated analyzer that uses ion exchange high performance liquid chromatography (HPLC) technology to separate glycated (labile A1c(L-A1c) and stable A1c (S-A1c)) and non-glycated (HbA0) forms of hemoglobin.

    Hemoglobin A1c measurements obtained from the ADAMS A1C HA-8180V are used as an aid in the diagnosis of diabetes mellitus, an aid in the identification of individuals who may be at risk of developing diabetes, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus. The subject device consists of the ADAMS A1c HA-8180V test analytical instrument and CALIBRATOR 80, which is used to calibrate the HA-8180V. The ADAMS A1c HA-8180V system is for use in professional clinical laboratory settings.

    This method is certified by the National Glycohemoglobin Standardization Program (NGSP).

    Hemoglobin test samples are prepared by automated dilution of anticoagulated whole blood in Hemolysis Washing Solution 80H. Alternately, hemolysis samples may be prepared "off-line" by manual dilution of anticoagulated whole blood with Diluent 80. The sample is then injected into the column, which contains a filter to remove sample impurities. The differing polarity and ionic charges of the released hemoglobin fractions bind with variable strength to the negatively charged stationary phase of the column. The mobile phase, consisting of three eluents of increasing ionic strength, is injected into the column. Hemoglobin fractions eluted from the column are identified and quantified using light absorption, and are measured at 420 nm and 500 nm. The dual wavelength colorimetric analysis of the separated peaks is processed by a microcomputer to obtain peak identification and hemoglobin fraction quantitation. All pre-analytical and analytical steps are performed automatically by the ADAMS A1c HA-8180V system. Tests may be ordered in batch or for STAT measurement.

    HbA1c and HbF results are reported in the presence of HbC, HbD, HbE, or HbS. A result of the detected HbC or HbS, and a peak resulting from HbD or HbE is also listed in the peak information. When a peak resulting from HbD or HbE is detected, a 'V' is listed in the peak information. HbA1c and HbF results are not reported when the instrument detects other peaks that affect HbA1c measurement value. The identification of any of these variants is not intended for use in diagnosis of hemoglobinopathies.

    AI/ML Overview

    This document describes the validation study for the ADAMS A1c HA-8180V system, a device for quantitative determination of hemoglobin A1c.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Precision: Performance testing must use blood samples with concentrations near 5.0%, 6.5%, 8.0%, and 12% HbA1c, evaluated over a minimum of 20 days using at least three lots of the device and three instruments.Precision demonstrated: The study used four donor samples at ~5.0%, ~6.5%, ~8.0%, and ~12.0% HbA1c, plus three quality control materials. It was evaluated using three reagent lots and three HA-8180V systems over 20 days, in duplicate, two runs per instrument per day. The total CV for whole blood samples combined across instruments ranged from 0.5% at 5.2% HbA1c to 1.0% at 11.8% HbA1c. For hemolysate samples combined across instruments, the total CV ranged from 0.4% at 5.2% HbA1c to 0.9% at 11.9% HbA1c. IFCC values also showed similar low CVs.
    Accuracy (Method Comparison): Performance testing must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method.Accuracy demonstrated: A method comparison study included 143 variant-free whole blood K2-EDTA samples ranging from 4.1% to 17.7% HbA1c. These were compared against a secondary NGSP reference laboratory (Tosoh G8 HPLC method). The weighted Deming regression for whole blood showed a slope of 0.9864 and an R² of 0.998. For hemolysate, the slope was 0.9906 and R² was 0.998. The findings demonstrated little to no bias.
    Total Error: Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6%.Total Error demonstrated: Total Error (TE) was calculated at 5.0%, 6.5%, 8.0%, and 12.0% HbA1c using bias from method comparison and CV from precision studies. For whole blood, the %TE ranged from 1.5% at 5.0% HbA1c to 2.4% at 12.0% HbA1c. For hemolysate, the %TE ranged from 1.6% at 8.0% HbA1c to 2.1% at 6.5% HbA1c. All reported %TE values were significantly less than the ≤6% acceptance criterion.
    Interference from Hemoglobin Variants: Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.Interference demonstrated: A study with 165 samples containing Hb variants (A2, C, D, E, F, S) showed that HbA1c results were accurate with no significant interference for HbA2 (≤16%), HbC (≤39%), HbD (≤36%), HbF (≤30%), HbS (≤40%). Bias results for HbA1c at ~6.5% and ~8.0% were generally within a low percentage range, indicating no significant interference.
    Standardization Verification: Device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by the FDA.Standardization verified: The HA-8180V HbA1c assay is NGSP certified, and certification is re-certified annually by ARKRAY. Traceability is established to the IFCC reference calibrators and the DCCT.

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

    • Precision Study:
      • Sample Size: 4 EDTA whole blood samples from different donors at approximate HbA1c concentrations of ~5.0%, ~6.5%, ~8.0%, and ~12.0%, and 3 quality control materials. Each sample was run in duplicate in two runs per instrument per day for 20 days across three instruments and three reagent lots.
      • Data Provenance: The study was conducted at ARKRAY, USA, Edina, MN. It is a prospective study, as samples were "utilized in the study" and data "collected at ARKRAY."
    • Method Comparison Study:
      • Sample Size: 143 variant-free whole blood K2-EDTA samples.
      • Data Provenance: The samples were collected from donors in an unspecified country (likely the US, given the study location in Minneapolis, MN) and were "variant-free." The study is likely prospective, involving the collection and testing of these specific samples.
    • Hemoglobin Variant Study:
      • Sample Size: 165 samples known to contain Hemoglobin variants A2, C, D, E, F, or S.
      • Data Provenance: Not explicitly stated, but implies a collection of samples with known variants, likely from a clinical setting. It's a retrospective analysis of samples or prospective collection of specific variant samples.

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

    Ground truth for the test set was not established by human experts in a subjective manner as it is an in vitro diagnostic device for quantitative measurements.

    • Precision Study: The ground truth was based on the device's own measurements of samples at known approximate HbA1c concentrations and quality control materials.
    • Method Comparison Study: The ground truth (reference method) was established by a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is itself standardized and traceable.
    • Hemoglobin Variant Study: The ground truth (reference method) was a method "that has been demonstrated to be free from the hemoglobin interference being tested." This implies an established and validated reference method for comparison, not expert consensus.

    4. Adjudication method for the test set

    Not applicable. This is a quantitative diagnostic device, and ground truth is established by reference methods or material characteristics, not subjective human assessment requiring adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

    No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic (IVD) system, not an imaging or interpretive device that typically involves human readers.

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

    Yes, the studies presented are standalone performance evaluations of the ADAMS A1c HA-8180V system. It is an automated analyzer, so its performance is inherently standalone (algorithm/instrument only) without human-in-the-loop performance affecting the results.

    7. The type of ground truth used

    • Precision Study: Intrinsic measurement from known samples and quality control materials.
    • Method Comparison Study: The "gold standard" or reference method was the results from a secondary NGSP reference laboratory using a previously cleared HPLC method (Tosoh G8), which is traceable to IFCC and DCCT.
    • Hemoglobin Variant Study: A "reference method that has been demonstrated to be free from the hemoglobin interference being tested."
    • Linearity/Reportable Range: Theoretical values based on dilution factors of samples with known low and high HbA1c concentrations.

    8. The sample size for the training set

    This device does not utilize a "training set" in the context of machine learning. It is a chemical analyzer based on ion exchange HPLC technology. Its performance characteristics (precision, accuracy, linearity, interference) are evaluated directly through studies, rather than by training a model on data.

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

    Not applicable, as there is no "training set" in the machine learning sense for this type of IVD device.

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