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510(k) Data Aggregation

    K Number
    K023407
    Device Name
    ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR
    Manufacturer
    ELAN DIAGNOSTICS
    Date Cleared
    2003-02-14

    (127 days)

    Product Code
    CGX
    Regulation Number
    862.1225
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR

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

    The ATAC Creatinine Reagent Kit, the ATAC Calibrator and the ATAC 8000 Random Access Chemistry System are intended for use as a system for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal dialysis and as a calculation basis for measuring other urine analytes.

    Device Description

    The ATAC PAK Creatinine Reagent Kit is intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine results are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis and as a calculation basis for measuring other urine analytes. The ATAC PAK Creatinines creatinine through the reaction of creatinine with alkaline picrate. The initial rate of absorbance increase at 510 nm is proportional to the creatinine concentration of the sample.

    AI/ML Overview

    The provided text describes the ATAC PAK Creatinine Reagent Kit and its performance characteristics. This is a medical device for in vitro diagnostic use, specifically a reagent kit for measuring creatinine levels. The information presented is typical for a 510(k) submission, demonstrating substantial equivalence to a predicate device.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, structured as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    For this type of in vitro diagnostic device (reagent kit), regulatory acceptance criteria typically revolve around accuracy, precision, linearity, and stability, often in comparison to a legally marketed predicate device. The document does not explicitly state "acceptance criteria" but rather presents the results of studies designed to demonstrate the device's performance.

    Performance MetricAcceptance Criteria (Implicit)Reported Device Performance
    LinearityCreatinine recovery should be linear across the usable range.Linear from 0.2 to 25 mg/dL.
    Regression statistics forced through origin: (ATAC Recoveries) = 0.997 x (Standard Value), Sy.x = 0.19 mg/dL.
    PrecisionDemonstrated by replicate assay of control serum. (Implicitly, comparable to predicate).Serum 1 (0.7 mg/dL): Within Run 1SD = 0.05, %CV = 6.9%; Total 1SD = 0.05, %CV = 7.4%
    Serum 2 (4.1 mg/dL): Within Run 1SD = 0.06, %CV = 1.6%; Total 1SD = 0.10, %CV = 2.5%
    Serum 3 (7.2 mg/dL): Within Run 1SD = 0.18, %CV = 2.5%; Total 1SD = 0.24, %CV = 3.3%
    Urine 1 (3.6 mg/dL): Within Run 1SD = 0.10, %CV = 2.8%; Total 1SD = 0.12, %CV = 3.3%
    Urine 2 (14.8 mg/dL): Within Run 1SD = 0.42, %CV = 2.9%; Total 1SD = 0.60, %CV = 4.0%
    Method ComparisonResults should correlate well with a commercially available method for serum/plasma and urine.Serum/Plasma: ATAC 8000 = 0.07 mg/dL + 0.956 x Competitive Reagent, r = 0.998
    Urine: ATAC 8000 = 0.02 mg/dL + 0.960 x Competitive Reagent, r = 0.998
    Calibration StabilityTotal imprecision of creatinine recoveries over the claimed period should be low.Total imprecision
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