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510(k) Data Aggregation

    K Number
    K041404
    Device Name
    CLEARBLUE EASY EASY READ PREGNANCY TEST
    Manufacturer
    UNIPATH LTD.
    Date Cleared
    2004-06-08

    (13 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Type
    Special
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CLEARBLUE EASY EASY READ PREGNANCY TEST

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

    Clearblue Easy Easy Read Pregnancy Test is an over-the-counter urine hCC test which is a qualitative immunoassay for the detection of human chorionic gonadotropin (hCG) in urine. The test is indicated for use from three days before the expected period.

    Device Description

    Not Found

    AI/ML Overview

    Here's an analysis of the provided text regarding the Clearblue Easy Easy Read Pregnancy Test, focusing on acceptance criteria and supporting studies:

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance CriteriaReported Device Performance
    Claimed Use: Over-the-counter urine hCG test for early pregnancy detection.The device is cleared for marketing as an over-the-counter urine hCG test.
    Indicated Use: From three days before the expected period.The device's indications for use specifically state "from three days before the expected period."
    Accuracy/Sensitivity/Specificity: Not explicitly stated in the provided text.Not explicitly stated in the provided text. However, the FDA's "substantial equivalence" determination implies that the device meets performance standards comparable to legally marketed predicate devices.

    Important Note: The provided FDA clearance letter focuses on establishing substantial equivalence to a predicate device for marketing purposes. It does not detail the specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy percentages) that Unipath Ltd. used in their internal validation studies, nor the detailed results of those studies. The letter only confirms that the FDA reviewed the 510(k) and found the device substantially equivalent.

    2. Sample Size Used for the Test Set and Data Provenance

    • Sample Size: Not specified in the provided document.
    • Data Provenance: Not specified in the provided document. The manufacturer is Unipath Ltd. based in the United Kingdom, so the studies could have been conducted there or elsewhere. The document does not indicate if the data was retrospective or prospective.

    3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

    • Number of Experts: Not specified in the provided document.
    • Qualifications of Experts: Not specified in the provided document.

    4. Adjudication Method for the Test Set

    • Not specified in the provided document. This type of detail is typically found in the full 510(k) submission, not the FDA clearance letter.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

    • Not Applicable: This device is an in-vitro diagnostic (IVD) pregnancy test, not an imaging device requiring human reader interpretation in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study as typically understood for AI in radiology, for example, would not be relevant. The "human readers" for this device are the users interpreting the visual result (lines/symbols).

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

    • Yes, implicitly: As an over-the-counter pregnancy test, the device is designed to be used by individuals without expert human intervention beyond interpreting the visual result. The "algorithm" in a qualitative test like this would be the chemical reaction leading to a visible line, and its performance is evaluated in a standalone manner (i.e., does the test correctly detect hCG in a sample). The 510(k) submission would have included data demonstrating the test's ability to accurately detect hCG levels.

    7. The Type of Ground Truth Used

    • Implicitly, clinical reference methods and/or known hCG concentrations: For a pregnancy test, ground truth would typically be established by:
      • Quantitative hCG measurements: Using highly accurate laboratory-based assays to determine the true hCG concentration in urine samples.
      • Clinical outcomes: Confirming pregnancy through other diagnostic methods (e.g., ultrasound, follow-up blood tests) to correlate with the test results.
      • Known hCG-spiked samples: Testing samples with precisely known concentrations of hCG to assess sensitivity and specificity at various levels.

    8. The Sample Size for the Training Set

    • Not specified in the provided document. This information would be part of the full 510(k) submission. For chemical-based IVDs, the concept of a "training set" in the machine learning sense is not directly applicable. Instead, there would be development and optimization phases where various reagents and designs are tested, and then validation studies on larger, independent sets.

    9. How the Ground Truth for the Training Set Was Established

    • Not specified in the provided document. Similar to point 8, the "training set" concept is different here. However, for the development and optimization of such a test, the ground truth would involve precisely prepared samples with known hCG concentrations and potentially clinical samples with confirmed pregnancy status obtained through reference laboratory methods.
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