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510(k) Data Aggregation

    K Number
    K973582
    Device Name
    ACE PRIMIDONE REAGENT, AED CALIBRATORS
    Manufacturer
    SCHIAPPARELLI BIOSYSTEMS, INC.
    Date Cleared
    1997-11-12

    (51 days)

    Product Code
    DJD
    Regulation Number
    862.3680
    Type
    Traditional
    Panel
    Toxicology (TX)
    Reference & Predicate Devices
    K960526
    Why did this record match?
    Product Code :

    DJD

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

    ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.

    ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.

    Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.

    Device Description

    The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.

    AI/ML Overview

    The ACE® Primidone Reagent is intended for the quantitative determination of primidone in human serum using the ACE® clinical chemistry analyzer. The device's performance was assessed by comparing it to a predicate device, the DRI Primidone Enzyme Immunoassay, and through non-clinical test results including within-run and between-run precision, and correlation against a Hitachi 717 analyzer.

    Here's a breakdown of the acceptance criteria and study details:

    1. Table of Acceptance Criteria and Reported Device Performance

    The submission does not explicitly state "acceptance criteria" as pass/fail thresholds for precision or correlation. Instead, it presents the performance of the proposed device alongside the predicate device's performance for comparison, implying that performance comparable to or better than the predicate is acceptable.

    ParameterImplied Acceptance Criterion (Compared to Predicate)Proposed Device PerformancePredicate Device Performance
    Assay RangeComparable or wider range0.3 µg/mL to 24 µg/mL0.5 µg/mL to 24 µg/mL
    Precision (Within Run)Comparable or better (%CV)
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