Search Results

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.

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.

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:

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

The document describes several test sets:

• Precision/Reproducibility Study:

  • Sample Size: For each hCG concentration, 135 tests were performed (e.g., at 10 mIU/ml, 135 pregnant results recorded). This was broken down by 3 batches (90 samples per batch per concentration) and 3 technicians (90 samples per technician per concentration) and 5 nonconsecutive days (54 samples per day per concentration). Total tests performed across all concentrations, methods, batches, and technicians sums to (8 concentrations * 2 methods * 3 batches * 5 replicates = 240) which does not match the 135 per concentration in the table. The "Total" column suggests (135 tests per concentration). Each combination of hCG standard, method (dip/in-stream), technician, and day was tested.
  • Data Provenance: Not explicitly stated (e.g., country of origin), but implies laboratory/analytical testing within a controlled environment. Retrospective/Prospective is not stated but suggests controlled laboratory testing.

• Detection of hCG in Early Pregnancy Clinical Samples:

  • Sample Size:
    • Day -10: 42 samples
    • Day -9: 72 samples
    • Day -8: 120 samples
    • Days -7 to 0: 204 samples per day
  • Data Provenance: "Early pregnancy urine samples from days -10 to 0 relative to the day of the missed period were collected." This indicates prospective collection from pregnant women. No country of origin is specified.

• Lay User Study:

  • Sample Size:
    • Overall: 295 volunteers (152 clinically pregnant, 143 clinically not-pregnant).
    • In-stream method: 116 (59 pregnant, 57 not-pregnant).
    • Dip method: 179 (93 pregnant, 86 not-pregnant).
  • Data Provenance: "Pregnant and not pregnant women volunteers with diverse educational and professional backgrounds and ages between 18 and 55 years old participated..." This is prospective data collected from volunteers. No country of origin is specified.

• Lay User Spiked Standard Study:

  • Sample Size: Varies per hCG standard: 107 samples at 0 mIU/ml, 107 at 2 mIU/ml, 103 at 3 mIU/ml, 106 at 5 mIU/ml, 105 at 10 mIU/ml, 108 at 15 mIU/ml.
  • Data Provenance: Spiked urine standards. This is controlled laboratory testing, likely prospective in nature for the study.

• Specificity Study (False-Positive Rate):

  • Sample Size: 899 not-pregnant women (300 pre-menopausal, 299 peri-menopausal, 300 post-menopausal).
  • Data Provenance: "Urine samples were collected from individual women of each cohort." This indicates prospective sample collection from various age groups.

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

• For the "Detection of hCG in Early Pregnancy Clinical Samples" and "Lay User Study": The ground truth for pregnancy status was established by "physician determined clinical pregnancy status." The number or specific qualifications (e.g., years of experience) of these physicians are not specified.
• For the "Analytical Performance" studies (Precision, Specificity, etc.): Ground truth was based on spiked hCG concentrations traceable to the WHO 4th International Standard, and known concentrations of interfering/cross-reacting substances. This does not rely on human "experts" to establish ground truth in the same way clinical studies do.

4. Adjudication Method for the Test Set

• Clinical Ground Truth: For the "Lay User Study" and "Detection of hCG in Early Pregnancy Clinical Samples," the ground truth was "physician determined clinical pregnancy status." There is no mention of an adjudication method (e.g., multiple physicians, consensus, tie-breaking) for discrepancies, suggesting a single physician's determination was used, or implicitly that the clinical status was clear and undisputed.
• Analytical Studies: Ground truth for these studies was based on controlled scientific measurements (known concentrations of hCG, interfering substances, etc.), so no human adjudication method was required.

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

No, an MRMC comparative effectiveness study was not explicitly stated or described as being performed.

The "Lay User Study" is a form of multi-reader study (multiple lay users reading the device), but it compares lay user results against clinical status and technician results, not against AI assistance. The document explicitly states: "The Lay User Usage study collected the lay users and technician results and compared them against physician determined clinical pregnancy status, hence the comparison to the predicate device was not performed." There is no mention of AI assistance.

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

This device is a physical, over-the-counter visual pregnancy test. It is not an AI/algorithm-driven device. Therefore, a standalone (algorithm-only) performance study is not applicable and was not conducted. The "performance" in this context refers to the chemical immunoassay and interpretation by human users.

7. The Type of Ground Truth Used

• Clinical Studies (Early Pregnancy Detection & Lay User Study): The ground truth for pregnancy status was physician determined clinical pregnancy status.
• Analytical Studies (Precision, Sensitivity, Specificity, etc.): The ground truth was based on known concentrations of hCG (traceable to WHO 4th International Standard) and controlled laboratory conditions using spiked urine samples with known concentrations of various substances.

8. The Sample Size for the Training Set

This document describes a diagnostic device (an immunoassay), not an AI/machine learning algorithm. Therefore, there is no concept of a "training set" for an algorithm. The performance studies described serve as validation studies for the device itself.

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

As there is no AI/machine learning algorithm involved, and thus no "training set," this question is not applicable.

Ask a specific question about this device