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510(k) Data Aggregation

    K Number
    K213379
    Device Name
    Clearblue ® Early Pregnancy Test
    Manufacturer
    SPD Swiss Precision Diagnostics GmbH
    Date Cleared
    2022-09-21

    (343 days)

    Product Code
    LCX
    Regulation Number
    862.1155
    Type
    Traditional
    Panel
    Clinical Chemistry (CH)
    Reference & Predicate Devices
    k123436
    Why did this record match?
    Device Name :

    Clearblue ® Early Pregnancy Test

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

    The Clearblue® Early Pregnancy Test is an over-the-counter chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine. This test is intended for use as an aid in early detection of pregnancy, in some cases as early as six (6) days before the day of the missed period, i.e. as early as five (5) days before the day of the expected period.

    The test is intended for home use.

    Device Description

    The Clearblue® Early Pregnancy Test is an over-the-counter (OTC), visual pregnancy test and is indicated for use up to 6 days before the missed period (5 days before expected period). The device employs an immunochromatographic sandwich assay to detect hCG on a lateral flow test strip.

    The test incorporates a proprietary, FSH modulated, hCG scavenger system positioned upstream of the hCG test line to maintain high specificity to pregnancy. The scavenger system captures hCG when there are high levels of FSH in the sample. This ensures that hCG is removed from samples with elevated levels of FSH, reducing the chance of false positive results which while rare, may occur in some women.

    The result is displayed to the user in the test window as two lines for a 'Pregnant' result and one line for a `Not Pregnant' result.

    AI/ML Overview

    The provided document describes the performance and testing of the "Clearblue® Early Pregnancy Test," a qualitative immunoassay for detecting human chorionic gonadotropin (hCG) in urine. This document pertains to its 510(k) premarket notification (K213379) to the FDA.

    Here's a breakdown of the acceptance criteria and study proving device performance, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document doesn't explicitly list "acceptance criteria" in a table format with pass/fail remarks. However, the performance characteristics sections imply certain criteria are met for the device to be considered substantially equivalent. Based on the studies, here is a summary of the implicit criteria and reported performance:

    Performance Metric (Implicit Acceptance Criteria)Reported Device Performance (Clearblue® Early Pregnancy Test)
    Accuracy (Lay User Study vs. Clinical Status)100% agreement (PPV, NPV, Sensitivity, Specificity)
    - Pregnant Cohort100% detection (152/152 pregnant samples correctly identified)
    - Not Pregnant Cohort100% negative results (143/143 not pregnant samples correctly identified)
    Accuracy (Lay User vs. Technician)100% agreement between lay user and technician results
    Precision/ReproducibilityConsistent results across technicians, batches, and days, especially at 10 mIU/ml hCG and above (100% pregnant results).
    - 10 mIU/ml hCG100% Pregnant results
    - 15 mIU/ml hCG100% Pregnant results
    - 20 mIU/ml hCG100% Pregnant results
    - *
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