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510(k) Data Aggregation

    K Number
    K171650
    Device Name
    Alere Afinion HbA1c and ACR on Afinion 2 analyzer
    Manufacturer
    Abbott Rapid Diagnostics
    Date Cleared
    2017-11-21

    (169 days)

    Product Code
    LCP, JFY, JQT
    Regulation Number
    864.7470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Abbott Rapid Diagnostics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Afinion™ 2 analyzer is a compact multi-assay analyzer for point-of-care testing, designed to analyze the Afinion™ test cartridges. Afinion™ 2 system, consisting of Afinion™ 2 analyzer and Alere Afmion™ test cartridges is for in vitro diagnostic use only. Alere Afinion™ HbA1c is an in-vitro diagnostic test for quantitative determination of glycated hemoglobin (% hemoglobin A1c, % HbA1c) in human whole blood. The measurement of % HbA1c is recommended as a marker of long term metabolic control in persons with diabetes mellitus. The Alere Afinion™ ACR assay is an in vitro diagnostic test for quantitative determination of albumin, creatinine and albumin/creatinine ratio (ACR) in human urine the Afinion™ 2 analyzer. The measurement of urine albumin, creatinine and albumin/creatinine ratio, aids in the early diagnosis of nephropathy.
    Device Description
    The Afinion™ 2 analyzer is a multi-assay analyzer for point-of-care testing, designed for use with Alere Afinion™ assays. The Afinion™ 2 analyzer is a modification, a new model, of the previously cleared device Alere Afinion™ AS100 Analyzer.
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