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510(k) Data Aggregation

    K Number
    K160113
    Device Name
    ST AIA-PACK hsE2 Calibrator Set
    Manufacturer
    TOSOH BIOSCIENCE, INC.
    Date Cleared
    2016-02-17

    (29 days)

    Product Code
    JIT,PAN
    Regulation Number
    862.1150
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K971103,K932084
    Why did this record match?
    Device Name :

    ST AIA-PACK hsE2 Calibrator Set

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

    The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

    Device Description
    • 2 x 1 mL ST AIA-PACK hsE2 Calibrator (1) 0 pg/mL Human serum containing no detectable concentration of estradiol with sodium azide as a preservative.
    • 2 x 1 mL ST AIA-PACK hsE2 Calibrator (2) 25 pg/mL (approx.)
    • ST AIA-PACK hsE2 Calibrator (3) 50 pg/mL (approx.)
    • ST AIA-PACK hsE2 Calibrator (4) 100 pg/mL (approx.)
    • ST AIA-PACK hsE2 Calibrator (5) 500 pg/mL (approx.)
    • ST AIA-PACK hsE2 Calibrator (6) 1,100 pg/mL (approx.)
      Human serum containing the assigned concentration of estradiol (described on each vial) with sodium azide as a preservative.
      ST AIA-PACK hsE2 Calibrator Set P/N # 025325
      The ST AIA-PACK hsE2 Calibrator Set is designed specifically for use on the Tosoh AIA System Analyzers which have been previously cleared as a family of instruments under K971103. Only materials obtained from Tosoh should be used. Materials obtained elsewhere should not be substituted since assay performance is characterized based strictly on Tosoh materials.
      The ST AIA-PACK hsE2 Calibrator Set is designed for use with ST AIA-PACK hsE2 and ST AIA-PACK hsE2 Sample Diluting Solution.
    AI/ML Overview

    The provided document describes the ST AIA-PACK hsE2 Calibrator Set and its performance.

    Here's an analysis of the acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document details two types of stability studies, each with its own acceptance criteria and results for recovery and reproducibility (CV%).

    Test TypeAcceptance Criteria (Recovery)Reported Device Performance (Recovery)Acceptance Criteria (Reproducibility - CV%)Reported Device Performance (Reproducibility - CV%)
    Real Time Testing100% +/- 10%Not explicitly stated; "Current Real Time Studies support a 12 month Shelf life at 2-8°C" implies criteria were met
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