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510(k) Data Aggregation

    K Number
    K162514
    Device Name
    Multichem A1c
    Manufacturer
    Technopath Manufacturing
    Date Cleared
    2016-10-26

    (48 days)

    Product Code
    JJX
    Regulation Number
    862.1660
    Type
    Abbreviated
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    K121534
    Why did this record match?
    Applicant Name (Manufacturer) :

    Technopath Manufacturing

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

    Multichem Alc control is intended for use as an assayed quality control to monitor the precision of laboratory testing procedures for the analyte, HbA1c, as listed in the package insert.

    Device Description

    The use of quality control materials is indicated as an objective assessment of the precision of methods and techniques in use and is an integral part of good laboratory practices. A minimum of two levels of control are available to allow performance monitoring within the clinical range of HbA1c assay method. Multichem A1c control is prepared from human red blood cells with added chemicals and stabilizers. The control is provided in liquid form for convenience.

    AI/ML Overview

    The provided document describes the Multichem A1c device, which is an assayed quality control material for monitoring the precision of laboratory testing procedures for HbA1c. The study described focuses on the stability and value assignment of this quality control material, rather than the performance of a diagnostic algorithm or device in detecting disease. Therefore, many of the requested categories for a diagnostic device (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, and standalone performance) are not applicable in the traditional sense.

    Here's the information that can be extracted and presented based on the context of a quality control device:

    1. Acceptance Criteria and Reported Device Performance

    Device: Multichem A1c (Assayed) Control

    Purpose: Quality Control Material for HbA1c testing.

    Acceptance Criteria CategorySpecific CriteriaReported Device Performance (Summary)
    Value Assignment RangesLevel 1:
    • % HbA1c (DCCT/NGSP): Target 4.00-7.00%
    • A1c (IFCC mmol/mol): Target 20.2-53.0 mmol/mol
      Level 2:
    • % HbA1c (DCCT/NGSP): Target 8.00-13.00%
    • A1c (IFCC mmol/mol): Target 63.9-119.0 mmol/mol | Value assignments performed successfully on Tosoh, Beckman, and Trinity analysers, with targets and ranges established for each. Specific targets and ranges for each level and analyzer combination are provided in Section 8.0. The control ranges are set based on 3 standard deviations of imprecision with a minimum applied range of ±10%. |
      | Open Vial Stability | Maximum Allowable Degradation / Drift Limit
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