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    K Number
    K980736
    Device Name
    ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST
    Manufacturer
    ACON LABORATORIES CO.
    Date Cleared
    1998-04-16

    (50 days)

    Product Code
    JHI
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    K903219
    Why did this record match?
    Device Name :

    ACON HCG ONE STEP URINE/SERUM PREGNANCY TEST

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

    The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid qualitative chromatographic immunoassay for the detection of human chorionic gonadotropin in urine or serum. The ACON hCG Urine/Serum One Step Pregnancy Test is indicated for use as an aid in the early detection of pregnancy.

    Device Description

    The ACON hCG Urine/Serum One Step Pregnancy Test is a rapid chromatographic immunoassay (membrane particle assay).

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Predicate Device K903219)Reported Device Performance (ACON hCG Urine/Serum One Step Pregnancy Test)
    Sensitivity20 mIU/ml15 mIU/ml (All samples tested at 15 mIU/ml produced positive results)
    Accuracy≥ 99%100% overall agreement (indicating ≥ 99% accuracy)
    SpecificityNo interferencesNo interferences with high concentrations of LH, FSH, TSH, and common substances

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

    • Urine Test Set:
      • Sample Size: 155 urine specimens.
      • Data Provenance: Not explicitly stated, but it was a "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
    • Serum Test Set:
      • Sample Size: 57 serum specimens.
      • Data Provenance: Not explicitly stated, but part of the same "multi-center clinical evaluation," suggesting prospective collection from various clinical sites. No country of origin is mentioned.
    • Sensitivity Test Set:
      • Sample Size: 20 clinical samples (from normal, non-pregnant females), spiked with hCG at various concentrations (0, 15, 20, 50, 100 mIU/ml).
      • Data Provenance: Clinical samples from normal, non-pregnant females. The spiking indicates laboratory-controlled conditions.
    • Specificity Test Set:
      • Sample Size: Not explicitly stated for each hormone (LH, FSH, TSH) or for interfering substances. The wording "all specimens tested" suggests multiple samples for each.
      • Data Provenance: Specimens with high physiological concentrations of relevant hormones and specimens spiked with potentially interfering substances.

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

    Not applicable. This device is an in-vitro diagnostic test for qualitative detection of hCG. The "ground truth" for the accuracy study was established by comparison to another commercially available membrane particle assay, implying the reference device's results were considered the ground truth. For sensitivity, the ground truth was the known concentration of spiked hCG. For specificity, the ground truth was the known presence or absence of specific interfering substances. No human expert interpretation was involved in establishing the ground truth for this type of test.

    4. Adjudication Method for the Test Set

    Not applicable. As noted above, the ground truth was established either by comparison to a predicate device's results or by known spiked concentrations/substances. There was no human interpretation requiring adjudication.

    5. 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

    Not applicable. This is an in-vitro diagnostic device that provides an objective visual result (colored lines); it is not an AI-powered image analysis or diagnostic aid that assists human readers.

    6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

    Yes, the studies described are standalone performance evaluations of the ACON hCG Urine/Serum One Step Pregnancy Test. The device itself performs the detection; there is no human interpretation of an algorithm's output.

    7. The Type of Ground Truth Used

    • Accuracy: Another "commercially available membrane particle assay" (likely the predicate device or a similar validated test). The results of this comparator assay served as the ground truth.
    • Sensitivity: Known, precisely spiked concentrations of hCG in clinical samples.
    • Specificity: Known concentrations of other hormones (LH, FSH, TSH) and common interfering substances.

    8. The Sample Size for the Training Set

    Not applicable. This is a rapid immunoassay test, not a machine learning or AI-based device that requires a "training set." Its principles of operation rely on biochemical reactions, not data-driven model training.

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

    Not applicable, as there is no training set for this type of device.

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