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510(k) Data Aggregation

    K Number
    DEN040001
    Device Name
    CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM
    Manufacturer
    ADVANCED DIAGNOSTIC SYSTEMS
    Date Cleared
    2004-01-21

    (19 days)

    Product Code
    NQI
    Regulation Number
    866.6020
    Type
    Post-NSE
    Panel
    Pathology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The CellSearch™ Epithelial Cell Kit is intended for the enumeration of circulating tumor cells (CTC) of epithelial origin (CD45-, EpCAM+, and cytokeratins 8, 18+ and/or 19+) in whole blood. The presence of CTC in the peripheral blood, as detected by the CellSearch™ Epithelial Cell Kit, is associated with decreased progression free survival and decreased overall survival in patients treated for metastatic breast cancer.

    Device Description

    The CellSearch™ Epithelial Cell Kit analyzed on the CellSpotter™ Analyzer is called the CellSearch Assay. The CellSearch Assay is a semi-automated in vitro diagnostic device. Epithelial cells are immunomagnetically labeled by targeting the Epithelial Cell Adhesion Molecule (EpCAM) antigen. Anti-EpCAM monoclonal antibodies conjugated to ferrofluid particles are colloidal and, when mixed with a sample containing the target epithelial cells, bind to the EpCAM antigen associated with the epithelial cells. After immunomagnetic selection of epithelial cells from 7.5 mL of blood, fluorescent reagents are added at this time to discriminate between the immunomagnetically selected cells. Anti-Cytokeratin - Phycoerythrin (CK-PE) stains the intracellular cytoskeleton cytokeratin proteins expressed in cells of epithelial origin, anti-CD45-Allophycocyan (CD45-APC) stains leukocytes and DAPI stains DNA present in the cell nucleus. A strong magnetic field is applied to the processed reagent/sample mixture that causes the labeled target cells to move to the cartridge surface. The cartridge is then placed on the CellSpotter™ Analyzer for data acquisition and analysis. The CellSpotter™ Analyzer acquires images of PE, APC and DAPI fluorescence staining of the entire viewing surface. After data acquisition is completed, the images are analyzed for any event where cytokeratin-PE and DAPI are within a specified space in the CellSpotter™ Cartridge, i.e. indicating the possible presence of a cell with a nucleus that expresses cytokeratin. Images from each fluorescent color as well as a composite image of the cytokeratin staining (green) and the nuclear staining (purple) are presented to the user in a gallery for final cell classification. A cell is classified as a tumor cell when it its EpCAM+ (i.e., it is captured), CK+, DAPI+ and CD45-. A check mark placed by the operator next to the composite images classifies the event as a Circulating Tumor Cell (CTC) and the software tallies all the checked boxes to obtain the CTC count.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study details for the CellSearch™ Epithelial Cell Kit and CellSpotter™ Analyzer, based on the provided document:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are implicitly derived from the performance goals demonstrated in the clinical and analytical studies, particularly concerning the predictive power of the CTC count cutoff for patient outcomes. The primary clinical acceptance is based on the device's ability to identify patients with decreased Progression-Free Survival (PFS) and Overall Survival (OS) using a defined cutoff.

    Performance MetricAcceptance Criteria (Implicit from Study)Reported Device Performance
    Analytical Performance
    Precision (Low Spike)Consistent and reproducible cell countsMean CTC Count per 7.5mL: 47, Total Precision Standard Deviation (ST) % CV: 15.8% (N=80)
    Precision (High Spike)Consistent and reproducible cell countsMean CTC Count per 7.5mL: 258, Total Precision Standard Deviation (ST) % CV: 9.4% (N=80)
    Reproducibility (Patient Samples 5 CTC/7.5mL (Table 3 shows means of 0.1-0.2, max 1-12, all single cases were below 5 for healthy and non-malignant other disease, one false positive for non-malignant breast disease).
    Cell RecoveryEfficient recovery of spiked cellsMean recovery of spiked cells approximately 85% (regression equation Y=0.85x +5.64, R=0.9973).
    Clinical Performance
    PFS Prediction (Baseline)CTC count of ≥5 should predict decreased PFSBaseline CTC ≥5 group (N=87) had median PFS of 11.7 weeks vs. 80 weeks. Log-rank p80 weeks. Log-rank p80/62.6 weeks) compared to those with ≥5 CTC at 1st follow-up (PFS 8.9 weeks, OS 35.4 weeks), all with high statistical significance (p
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