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    K Number
    K983473
    Device Name
    FERTILMARQ TEST KIT
    Manufacturer
    EMBRYOTECH LABORATORIES, INC.
    Date Cleared
    1998-12-17

    (76 days)

    Product Code
    POV,GKZ
    Regulation Number
    864.5220
    Type
    Traditional
    Panel
    Hematology
    Reference & Predicate Devices
    K915229
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    Device Name :

    FERTILMARQ TEST KIT

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

    The FertilMARQ™ Test Kit is a semi-quantitative test for the rapid analysis of sperm concentration to aid in the determination of male infertility.

    Device Description

    The FertilMARQ™ Test Kit is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples in duplicate. The kit contains components intended to hold, treat, and test collected semen (pre-coated collection cups, disposable pipettes, test cassettes), reagents intended to stain and wash semen samples collected on the test cassette. Positive and negative control wells are incorporated into the cassette design. In addition, the package insert and a Test Results form are included in the Kit. The Kit and all components are stored at room temperature. - The test operates by physical separation of sperm from seminal plasma and other semen components after a sample is dropped onto the filter incorporated into the test cassette. The staining reagent (Thiazine Blue) reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured and vield a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm, as compared to the negative control result, an intrinsic part of the assay.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Acceptance Criteria and Device Performance for FertilMARQ™ Test Kit

    This report details the performance of the FertilMARQ™ Test Kit, a semi-quantitative test for rapid sperm concentration analysis, and how it meets its acceptance criteria.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Implicit)Reported Device Performance (Test Set)
    High Sensitivity98% (identifying sperm concentration ≥ 20 million/mL)
    High Specificity98% (identifying sperm concentration = 95%"). The reported performance metrics are presented as evidence of equivalence to the predicate device and the standard microscopic method, implying these are the benchmarks for acceptance.

    2. Sample Size and Data Provenance for the Test Set

    • Sample Size:
      • Clinical Evaluation: 162 semen samples
      • Dilution Study: 32 semen samples (19 samples with sperm concentration ≥ 20 million/mL, 13 samples with sperm concentration
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