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    K Number
    K111335
    Device Name
    ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321
    Manufacturer
    Tosoh BioScience, Inc.
    Date Cleared
    2011-12-01

    (203 days)

    Product Code
    CKG,JIT,JJX
    Regulation Number
    862.1025
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ST AIA-PACK ACTH, AND ST AIA-PACK ACTH CALIBRATOR SET MODEL 025221 AND 025321

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

    ST AIA-PACK ACTH is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of adrenocorticotropic hormone (ACTH) in human EDTA plasma. Measurements of ACTH are used in the differential diagnosis and treatment of certain disorders of the adrenal glands such as Cushing's syndrome, adrenocortical insufficiency, and the ectopic ACTH syndrome.

    ST AIA-PACK ACTH Calibrator Set is designed for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

    ST AIA-PACK ACTH Control Set is designed for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK ACTH assay on Tosoh AIA System Analyzers

    Device Description

    The ST AIA-PACK ACTH is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK ACTH test cups. ACTH present in the test sample is bound with anti-ACTH goat polyclonal antibody immobilized on magnetic beads and enzyme-labeled anti-ACTH goat polyclonal antibody. The magnetic beads are washed to remove unbound enzyme-labeled anti-ACTH goat polyclonal antibody and are then incubated with a fluorogenic substrate, 4methylumbelliferyl phosphate (4MUP). The enzyme alkaline phosphatase causes oxidation of 4MUP to 4MU. 4MU is excited at 365 nm and comes to ground state at 448 nm releasing florescent energy. The amount of florescent energy is measured by the detector.

    The amount of enzyme-labeled anti-ACTH goat polyclonal antibody that binds to the beads is directly proportional to the ACTH concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.

    AI/ML Overview

    The ST AIA-PACK ACTH assay is designed to quantitatively measure adrenocorticotropic hormone (ACTH) in human EDTA plasma for in vitro diagnostic use. The following information details the acceptance criteria and the studies conducted to demonstrate the device's performance, as outlined in the 510(k) summary.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Performance MetricAcceptance Criteria (Internal/Guideline)Reported Device Performance
    Precision (Within-Run CV%)Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays.Reagent Set #1: Level A: 3.1%, Level B: 2.1%, Level C: 1.5%
    Reagent Set #2: Level A: 2.8%, Level B: 2.1%, Level C: 2.1%
    Reagent Set #3: Level A: 2.2%, Level B: 2.3%, Level C: 2.2%
    Precision (Total CV%)Not explicitly stated as acceptance criteria, but within typically acceptable ranges for immunoassays.Reagent Set #1: Level A: 3.3%, Level B: 2.5%, Level C: 2.2%
    Reagent Set #2: Level A: 4.2%, Level B: 3.8%, Level C: 3.4%
    Reagent Set #3: Level A: 2.5%, Level B: 2.8%, Level C: 2.2%
    LinearityRepeatability CV%
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