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    K Number
    K021541
    Device Name
    NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT
    Manufacturer
    PERKINELMER LIFE SCIENCES
    Date Cleared
    2002-10-28

    (171 days)

    Product Code
    JNB,CDR,JJE
    Regulation Number
    862.1555
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    510k Summary Text (Full-text Search) :

    Re: K021541

    Trade/Device Name: NeoGram PKU Tandem Mass Spectrometry Kit Regulation Number: 21 CFR 862.1555

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

    The NeoGram PKU Tandem Mass Spectrometry Kit is intended for screening for Phenvlketonuria (PKU). It involves the quantitative determination of phenvlalanine, tyrosine and the phenylalanine to tyrosine ratio (Phe/Tyr) in blood specimens dried on filter paper. This will aid in identifying newborns with PKU. It is intended for use by trained, qualified laboratory personnel.

    Device Description

    The assay involves the extraction of dried blood spots with a solution containing stable, isotopically labeled internal standards. The response of each amino acid relative to the isotopically labeled standards in the kit is proportional to their actual concentration. The analysis of the material is performed on a tandem mass spectrometer. Control material contained in the kit allows for verification of performance for the test run.

    AI/ML Overview

    Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance:

    The document doesn't explicitly state "acceptance criteria" in a quantitative format for the NeoGram PKU Tandem Mass Spectrometry Kit. However, it implicitly demonstrates performance through comparison with a legally marketed predicate device (Isolab Phenylalanine Test Kit) and provides descriptive statistics. The implicit acceptance criterion is likely substantial equivalence to the predicate device, demonstrated by similar performance characteristics.

    Performance MetricPredicate Device (Fluorometric method)NeoGram PKU Tandem Mass MethodImplied Acceptance Criteria (relative to predicate)Device Performance (NeoGram PKU)
    Mean Phenylalanine Concentration (mg/dl)1.11.1Similar mean concentration1.1 mg/dl
    Standard Deviation (mg/dl)0.30.2Similar or improved precision0.2 mg/dl
    Linearity (approx.)21 mg/dl (fluorometric)35 mg/dl (TMS)Equal or wider linearity range35 mg/dl (TMS)

    2. Sample size used for the test set and the data provenance:

    • Sample Size: 3679 samples
    • Data Provenance: Not explicitly stated whether retrospective or prospective, or country of origin.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

    This information is not provided in the document. The "ground truth" for the test set appears to be the results obtained by the legally marketed predicate device (Isolab Phenylalanine Test Kit), which served as the comparator.

    4. Adjudication method for the test set:

    This information is not provided in the document. The comparison is made against the results from the predicate device, implying a direct comparison rather than an adjudication process involving multiple human readers for discrepancies.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    Not applicable. This device is a diagnostic kit for quantitative determination of analytes, not an AI-based image analysis or decision support system that involves human readers in the capacity described by MRMC studies. The "AI" concept isn't relevant to this type of device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

    Yes, in essence. The performance presented is for the NeoGram PKU Tandem Mass Spectrometry Kit itself, as a standalone diagnostic system, performing the quantitative determination of phenylalanine, tyrosine, and Phe/Tyr ratio. While trained laboratory personnel operate the machine, the performance metrics (mean and standard deviation) are those of the machine's output.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

    The "ground truth" used for comparison appears to be the results obtained from a legally marketed predicate device (Isolab Phenylalanine Test Kit), specifically the "Fluorometric method." This provides a benchmark for expected performance in a clinical setting.

    8. The sample size for the training set:

    This information is not provided in the document. The document refers to a "calibration curve" for the predicate device and "internal standard comparison" for the new device, but details on the data used to establish these are not given.

    9. How the ground truth for the training set was established:

    This information is not provided in the document. For analytical devices, the "training set" would typically involve calibrators and control materials with known concentrations, but the specifics of how these known concentrations were established (e.g., against a reference standard) are not detailed.

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