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510(k) Data Aggregation

    K Number
    K033055
    Device Name
    GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
    Manufacturer
    DIAMOND DIAGNOSTICS, INC.
    Date Cleared
    2004-01-30

    (123 days)

    Product Code
    CGA
    Regulation Number
    862.1345
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K942676,K864236
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

    Device Description

    Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen Electrode. Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample. Mission manufactures reagents intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM). All CX® & CX® Delta Systems that measure glucose utilize the same measurement method and reagent. The reagent is intended for use on equivalent OEM Instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

    AI/ML Overview

    Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device meets these criteria.

    Acceptance Criteria and Device Performance for Mission Diagnostic Glucose Reagent

    This medical device is an in-vitro diagnostic reagent intended for the quantitative determination of glucose in various biological samples (serum, plasma, CSF, and urine) on Beckman Synchron CX® & CX® Delta Systems. The goal of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (Beckman PN 443355 Glucose Reagent). Therefore, the acceptance criteria are implicitly tied to demonstrating comparable performance to the predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance

    Given that this is a 510(k) for a glucose reagent intended to be substantially equivalent to an existing one, the "acceptance criteria" are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to show that the Mission Glucose Reagent performs similarly to the predicate Beckman reagent. The reported performance metrics are designed to demonstrate this similarity across various aspects.

    Performance MetricImplied Acceptance Criterion (relative to predicate)Mission Glucose Reagent PerformanceSupporting Study/Data
    Precision (Within-Run & Total %CV)Should be comparable to or better than predicate, and clinically acceptable for glucose measurement.CSF Control 1: Swr %CV 1.3%, ST %CV 6.3%
    CSF Control 2: Swr %CV 5.0%, ST %CV 10.1%
    Serum Control 1: Swr %CV 2.3%, ST %CV 6.7%
    Serum Control 2: Swr %CV 0.1%, ST %CV 7.0%
    Urine Control 1: Swr %CV 2.3%, ST %CV 5.1%
    Urine Control 2: Swr %CV 0.8%, ST %CV 5.0%NCCLS Guideline EP5-A Precision Study
    Method Comparison (Correlation with Predicate)Strong linear correlation, slope near 1, intercept near 0, high R-squared value, and acceptable standard error of the estimate.Serum: Mission = 1.038 x Beckman - 2.31; r² = 0.998; Range = 0 to 900 mg/dL; S(vx) = 9.00 mg/dL (n=50)
    Urine: Mission = 1.022 x Beckman + 1.067; r² = 0.998; Range = 1 to 293 mg/dL; S(vx) = 2.85 mg/dL (n=57)
    CSF: Mission = 1.014 x Beckman - 0.920; r² = 0.997; Range = 8 to 118 mg/dL; S(vx) = 1.68 mg/dL (n=36)NCCLS Guideline EP9-A2 Method Comparison Study
    Recovery to Expected ValuesPercentage recovery of spiked/diluted samples should be similar for Mission and Beckman reagents across various concentrations.Serum: Mission 83.3-115.4% (mean 103%), Beckman 83.3-117.5% (mean 103%)
    Urine: Mission 88-120% (mean 101%), Beckman 87-110% (mean 97%)
    CSF: Mission 88-98% (mean 94%), Beckman 88-100% (mean 95%)Recovery to Expected Values Evaluation
    Functional Sensitivity (Lower Limit of Detection)Performance at low concentrations, particularly %CV less than 20% at clinically relevant low levels.Lowest level with %CV
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