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510(k) Data Aggregation

    K Number
    K961278
    Device Name
    COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
    Manufacturer
    COULTER CORP.
    Date Cleared
    1996-07-22

    (110 days)

    Product Code
    GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K922745,K922744,K885093,K932030
    Why did this record match?
    Reference Devices :

    K922745, K922744, K885093, K932030

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

    COULTER STKS Analyzer with CD4 and CD8 Lymphocyte Analysis is a complete system consisting of reagents, sample processing accessories, instrument and software. The system is intended "For In Vitro Diagnostic Use" to identify and enumerate CD4+ and CD8+ T lymphocyte percentages and absolute counts in whole blood using either of two versions of a quantitative, automated hematology analyzer and leukocyte differential counter: COULTER® STKS Analyzer or COULTER® STKS Analyzer with Reticulocyte Analysis. The system is also intended to provide the CD4/CD8 ratio, a complete blood count (CBC) and a white blood cell (WBC) differential. Reticulocyte percentage and absolute count are only available if using the COULTER® STKS Analyzer with Reticulocyte Analysis.

    Device Description

    COULTER® STKS Analyzer with CD4 and CD8 Lymphocyte Analysis is a complete system consisting of reagents, sample processing accessories, instrument and software.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the COULTER® STKS Analyzer with CD4 and CD8 Lymphocyte Analysis, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria CategorySpecific Acceptance Criteria (Implied)Reported Device Performance
    AccuracySubstantial equivalence to comparator method (CD3/CD4 and CD3/CD8 by Flow Cytometry) for CD4+ and CD8+ T lymphocyte percentages and absolute counts. Identification and enumeration of essentially identical numbers of lymphocytes.Demonstrated that STKS with CD4 and CD8 Analysis and CD3/CD4 and CD3/CD8 by Flow Cytometry identify and enumerate essentially identical numbers of lymphocytes in whole blood specimens.
    LinearityDemonstrate linearity of assays across a range of CD4+ or CD8+ T lymphocyte concentrations.Demonstrated linearity of the assays using regression analyses and 95% confidence intervals of recovered versus expected absolute counts.
    Within Run (Intralaboratory) PrecisionDemonstrate acceptable precision for CD4+ and CD8+ T lymphocyte concentrations on the same day.Demonstrated within-run precision of the assays using means ± 1 SD and CVs.
    Between Run (Run-to-Run) PrecisionDemonstrate acceptable consistency between duplicate measurements on a STKS.Demonstrated between-run precision of the assays using minimums, maximums, means, and mean differences between runs ± 1 SD.
    Interlaboratory PrecisionDemonstrate acceptable precision across different technicians and instruments for CD4+ and CD8+ T lymphocyte concentrations.Demonstrated within-run (intralaboratory) precision of the assays using means ± 1 SD and CVs (Note: The text states "within run (intralaboratory) precision" for the interlaboratory section, which appears to be a typo or an overlap in the description as it should ideally reflect interlaboratory measures).

    Study Details

    1. Sample Size Used for the Test Set and Data Provenance:

      • Sample Size: Not explicitly stated as a number. The study used "Normal and abnormal (i.e., HIV, organ transplant, cancer, autoimmune disease) whole blood specimens."
      • Data Provenance: Specimens were collected from a "geographically diverse population of males and females unselected as to race and ranging in age from 18 to 85 years." This indicates data from human subjects but does not specify a country. It is a prospective collection for the purpose of this study, as specimens were divided and processed specifically for the comparison.

    2. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

      • Number of Experts: Not applicable. The "ground truth" and comparator method in this study are established laboratory techniques (flow cytometry using specific antibody reagents). The comparison is between two analytical methods, not dependent on expert visual review or judgment for establishing the reference.
      • Qualifications of Experts: N/A, as the ground truth is a technical measurement from a comparator device.

    3. Adjudication Method for the Test Set:

      • Adjudication Method: Not applicable. The study compares quantitative measurements from two different instruments/methods. There is no human adjudication process involved in resolving discrepancies between interpretations, as it's a direct numerical comparison.

    4. 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:

      • MRMC Study: No. This is a study comparing an automated hematology analyzer to a flow cytometer for lymphocyte analysis, not evaluating human reader performance with or without AI assistance. The device itself performs the analysis.

    5. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

      • Standalone Performance: Yes. The study directly assesses the performance of the COULTER® STKS Analyzer with CD4 and CD8 Lymphocyte Analysis (the subject device) by comparing its output (percentages and absolute counts) to a comparator method (flow cytometry). Both are automated analytical processes, and the performance described is that of the device itself.

    6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

      • Ground Truth Type: A comparator analytical method. The "ground truth" or reference standard for this study is the results obtained from CD3/CD4 and CD3/CD8 by Flow Cytometry using specified reagents (CD3(1gG1)-FITC/T4-RD1 or CD3(1gG1)-FITC/T8-RD1 on an EPICS XL-MCL or EPICS Profile II flow cytometer). This is a well-established and accepted method for lymphocyte immunophenotyping.

    7. The Sample Size for the Training Set:

      • Sample Size: Not applicable. The provided document describes a performance validation study for a medical device (COULTER® STKS Analyzer) that uses predefined algorithms and reagents. There is no mention of machine learning or deep learning, and thus no "training set" in the computational sense. The device's algorithms would have been developed and validated internally by the manufacturer prior to this submission.

    8. How the Ground Truth for the Training Set Was Established:

      • Ground Truth Establishment: Not applicable, as there is no "training set" for machine learning described. The device's internal algorithms are based on established principles of flow cytometry and hematology analysis.
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