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510(k) Data Aggregation

    K Number
    K053612
    Device Name
    DRI-STAT ACID PHOSPHATASE REAGENT
    Manufacturer
    BECKMAN COULTER, INC.
    Date Cleared
    2006-04-26

    (120 days)

    Product Code
    CKB
    Regulation Number
    862.1020
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K821674
    Why did this record match?
    Device Name :

    DRI-STAT ACID PHOSPHATASE REAGENT

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

    Dri-STAT® Reagent ACP is intended for use in the in vitro diagnostic determination of total acid phosphatase and non-prostatic acid phosphatase in human serum as a User Defined Reagent (UDR) application on SYNCHRON® Systems.

    Device Description

    The Dri-STAT® Reagent ACP may be used on the family of Synchron Systems. The reagent kit contains 20 reagent bottles that needs to be manually transferred into a Beckman Coulter User-Define Cartridge. Also with 1 bottle of Acetate Buffer. The reagent kit contains a bottle of Acetate Buffer along with a sample treatment.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Dri-STAT® ACP Reagent, based on the provided text:

    Acceptance Criteria and Device Performance

    The provided document does not explicitly state pre-defined acceptance criteria in the typical sense of threshold values (e.g., "r-value > 0.95"). Instead, it presents performance data for method comparison and imprecision. The implicit acceptance criterion is that the performance of the candidate device (Dri-STAT® ACP Reagent on Synchron Systems) is substantially equivalent to the predicate device (Dri-STAT® ACP Reagent on Cobas Fara). Substantial equivalence is demonstrated through the presented performance data.

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance (Dri-STAT® ACP Reagent on Synchron Systems)
    Method ComparisonSubstantially equivalent to predicate device (Dri-STAT® ACP on Cobas Fara)
    TACP (Synchron LX)High correlation (R) and reasonable slope/interceptSlope: 1.093, Intercept: 0.143, R: 0.994 (n=94)
    NPAP (Synchron LX)High correlation (R) and reasonable slope/interceptSlope: 1.066, Intercept: -0.197, R: 0.979 (n=47)
    TACP (Synchron CX)High correlation (R) and reasonable slope/interceptSlope: 1.075, Intercept: 0.460, R: 0.997 (n=94)
    NPAP (Synchron CX)High correlation (R) and reasonable slope/interceptSlope: 1.088, Intercept: -0.172, R: 0.994 (n=47)
    Imprecision (TACP)Low coefficient of variation (%C.V.) for controls and human pool
    Within-Run (Control 1)Not specified explicitly, but generally
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