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510(k) Data Aggregation

    K Number
    K070484
    Device Name
    QUANTRX FEMALE FERTILITY TEST
    Manufacturer
    QUANTRX BIOMEDICAL CORPORATION
    Date Cleared
    2007-10-22

    (244 days)

    Product Code
    NGA
    Regulation Number
    862.1300
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    k032002,k010556,k041165,k893976
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The QuantRx Female Fertility Test is intended to measure follicle-stimulating hormone (FSH) in urine as an ancillary screen of fertility for home use by women who are attempting to conceive.

    Device Description

    The QuantRx Female Fertility Test is a rapid, immunochromatographic assay for the measurement of follicle-stimulating hormone (FSH) in human urine. The test is performed on day 3 of the menstrual cycle by urinating directly on the absorbent tip or by dipping it in a cup of urine, and observing for the formation of colored lines after 10 minutes. A test line of color intensity greater than or equal to the reference line indicates an FSH level of at least 10 mIU/mL is indicative of diminished ovarian reserve, which corresponds to reduced fertility. A test line intensity of less than the reference line is indicative of normal ovarian reserve.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study details for the QuantRx Female Fertility Test, based on the provided 510(k) summary:

    Acceptance Criteria and Device Performance

    Acceptance CriteriaReported Device Performance
    Primary Study: - Concordance (trained user) between proposed device vs. laboratory method89%
    - Concordance (layperson) between proposed device vs. laboratory method88%
    - Concordance trained user vs. layperson for primary study98%
    Supplemental Study: - Concordance (trained user) between proposed device vs. predicate94%
    - Concordance (layperson) between proposed device vs. predicate92%
    - Concordance trained user vs. layperson for supplemental study98%
    The device is intended to measure FSH in urine, with a test line intensity equal to or darker than the reference line (calibrated at 10 mIU/mL) indicating FSH ≥ 10 mIU/mL, and a lighter intensity indicating FSH < 10 mIU/mL.The study results indicate concordance with laboratory and predicate methods, supporting the device's ability to discriminate FSH levels at the 10 mIU/mL threshold for both trained and lay users.
    The Control line must always appear, indicating the test performed properly; its absence results in an "invalid" test.Not explicitly quantified in the provided summary, but implied by the device description as a functional requirement for valid results.

    Study Details

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

      • Primary Study: 209 females (for consumer study, and the same combination of fresh/blinded control specimens for professional study). The origin of this data (e.g., country) is not specified. It is likely prospective for the consumer and professional studies, as it describes a comparison to a validated lab method using freshly collected and blinded control specimens.
      • Supplemental Consumer Study: 48 females. 40 of these provided paired serum specimens. Data provenance (e.g., country) is not specified. This also appears to be prospective as it involves women performing the test and providing specimens.

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

      • The document refers to a "published, validated, quantitative, chemiluminescent method for urine follicle-stimulating hormone (FSH)" and an "FDA cleared serum FSH assay (DPC IRMA FSH; K893976)" as the ground truth.
      • The number of experts involved in the initial validation of these laboratory methods is not specified, nor are their individual qualifications (e.g., specific years of experience or board certifications). The ground truth is established by the results of these validated and cleared laboratory methods, rather than by human expert consensus on interpretations of the device's results.

    3. Adjudication method for the test set:

      • No adjudication method (e.g., 2+1, 3+1) is described for the test set. The comparison is made directly between the QuantRx device's results and the results from the established laboratory methods.

    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:

      • No MRMC comparative effectiveness study involving AI or human reader improvement with AI assistance was conducted or mentioned. This device is a rapid diagnostic test, not an AI-powered image analysis tool. The study did compare "trained user" vs. "layperson" performance, which is a form of multi-reader evaluation, but not focused on AI assistance. The concordance between trained user and layperson for the primary and supplemental studies was 98%, suggesting very high agreement between these two user groups.

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

      • This is not applicable to the QuantRx Female Fertility Test, as it is a visual, rapid immunochromatographic assay that requires human interpretation of color lines. It is not an algorithm-only device. The performance data explicitly includes "trained user" and "layperson" results, indicating human-in-the-loop performance.

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

      • The ground truth was established using results from a published, validated, quantitative, chemiluminescent method for urine follicle-stimulating hormone (FSH) and an FDA cleared serum FSH assay (DPC IRMA FSH; K893976). This is a laboratory-based, quantitative measurement of the analyte of interest.

    7. The sample size for the training set:

      • The document describes performance studies (primary and supplemental) which serve as validation. It does not explicitly mention a separate "training set" in the context of machine learning, as this is not an AI/ML device. The studies described are evaluation studies comparing the device to reference methods.

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

      • See point 7. No specific "training set" or method for establishing its ground truth is described, as the device is a chemical immunoassay, not an AI/ML system that requires a distinct training phase.
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