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VeriClear™ Digital Early Result Pregnancy Test is a rapid chromatographic immunoassay for qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

The VeriClear™ hCG Early Result Pregnancy Test utilize the identical immunochemical principles for the detection of hCG in the urine as in K172257. It is a device intended for use by the lay user in the early detection of pregnancy by way of a series of immunochromatographic assay using colloidal gold as a direct label. The subject 510(k) device differs in which it provides a digital display of the test result for the consumer to read in place of the colored lines of the above referenced analog device. The VeriClear™ Digital Early Result Pregnancy Test device incorporates electronic and optical components along with a microprocessor and specific algorithms into the plastic housing. VeriClear™ Digital Early Result Pregnancy Test is capable of correctly determining and interpreting the test results correctly, and shows the results as "YES+" (Pregnancy), "NO-" (Non-pregnancy) or "?" (Error) on a display. The VeriClear™ Digital Early Result Pregnancy Test is powered by battery and the testing results will be displayed on the screen until the battery is used up.

All components are integrated and unitized into the plastic housing.

This document describes the performance of the VeriClear™ Digital Early Result Pregnancy Test. Here is a summary of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for a qualitative pregnancy test primarily revolve around its ability to accurately detect hCG at specified concentrations, particularly at the claimed sensitivity level, and its reliability across different conditions and users.

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

• Analytical Sensitivity:
  • 45 replicates (3 operators x 3 days x 5 replicates per run) for each hCG level (0 to 25 mIU/ml) and for each of 3 lots, using both dipping and simulated stream methods.
• Precision/Reproducibility:
  • Within-lot: 20 replicates for each hCG level (0 to 100 mIU/ml) using one lot, by a single operator.
  • Inter-lot: 150 replicate data points (5 operators x 5 days x 2 replicates per run x 3 lots) for each hCG level (0 to 100 mIU/ml), using both simulated stream and dipping methods.
• High Dose Hook Effect: Negative urine samples spiked up to 450,000 mIU/ml, tested in 2 replicates per lot using 2 lots.
• Analytical Specificity (Interference): Each interfering substance tested in 5 replicates per lot using 2 lots, spiked into negative and 10 mIU/ml hCG urine.
• Analytical Specificity (Cross-reactivity): Each cross-reactant (hLH, hFSH, hTSH) tested by two operators using two lots of test kits on negative and 10 mIU/ml hCG urine.
• Effect of urine pH: Urine pools adjusted to pH 4-9, tested with spiked and non-spiked hCG. Specific number of tests not specified but described qualitatively.
• Effect of urine specific gravity: Urine samples with varying specific gravity (1.003-1.030) spiked with 10 mIU/ml hCG, tested in duplicate.
• Effect of hCG β-core fragment: hCG free and hCG standard samples (5, 10, 25, 20,000 mIU/ml) spiked with fragments, tested on two lots.
• Method Comparison: 366 urine samples (215 suspected pregnant) collected from women at physician offices, tested with two different health care professionals using two lots (one for stream, one for dipping). Data provenance is likely U.S. based on the FDA filing, and appears to be retrospective (samples collected and then tested against devices).
• Early Pregnancy Detection: 616 urine samples collected from 56 women (25-43 years old) who planned to become pregnant. Samples collected from day -9 to day +1 relative to expected period. This suggests a prospective study design. Data provenance not explicitly stated but likely domestic.
• Lay User Study: 109 female subjects.
  • Tested their own urine samples.
  • Tested 4 blind hCG urine samples (3.0, 7.5, 8.5, 10 mIU/ml), with 109 samples tested for each hCG level (50 stream, 59 dipping). Data provenance not explicitly stated.
• Specificity Study (False-Positive Rate): 320 subjects provided urine samples (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal). All samples tested with three lots of devices. Data provenance not explicitly stated.

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

• Method Comparison: Ground truth for pregnancy status was established by comparison with a predicate device (First Response Digital Early Result Pregnancy Test) for the 366 samples. The results of the new device were compared against the predicate's results. It does not explicitly state experts established the ground truth for this set, but rather that two different health care professionals performed the testing with the devices.
• Early Pregnancy Detection: The "hCG Positive Ratio" implies that quantitative hCG measurements (likely from a laboratory method) were used as the ground truth. No specific number or qualifications of experts are mentioned for establishing this ground truth, but it would typically involve clinical laboratory professionals.
• Lay User Study: "Professional user" interpretation was used as a reference point for the lay user study, meaning a professional established the "ground truth" for the blind hCG samples. The qualifications of these professionals are not explicitly stated, but are implied to be laboratory or clinical staff competent in interpreting such tests.
• Specificity Study (False-Positive Rate): Ground truth for the 320 samples of non-pregnant women was established by Microwell Quantitative hCG test (an external lab method) and clinical confirmation of pregnancy for any positive results (presumably by an OB/GYN or other physician). No specific number or qualifications for the "clinical confirmation" experts are listed.

4. Adjudication Method for the Test Set

• Method Comparison: Samples were "masked and randomized by people who did not participate in the testing." Two different health care professionals tested the samples. The document does not describe an explicit adjudication method if their readings differed from the predicate or each other, but the results table shows perfect agreement between the new device's readings and the predicate, suggesting no discrepancies or a resolution process not detailed.
• Lay User Study: Lay user results were compared against "professional user" interpretations. This implies the professional users acted as the ground truth adjudicators.
• Other studies (precision, sensitivity, linearity, specificity) primarily relied on controlled, spiked samples with known concentrations, or comparison to established quantitative lab methods (e.g., Microwell Quantitative hCG test). Adjudication as typically understood for human reader variability would not be applicable in these analytical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No formal MRMC comparative effectiveness study, as typically performed for diagnostic imaging, was described. The device is a qualitative, over-the-counter pregnancy test.
• Instead, the "Lay User Study" and "Method Comparison with Predicate Device" serve a similar purpose by evaluating human performance (lay users vs. professionals, and general healthcare professionals with the new device vs. predicate). These studies demonstrate ease of use and agreement with professional assessment/predicate, but do not quantify an "effect size of how much human readers improve with AI vs without AI assistance" because this is a digital display test primarily, simplifying interpretation rather than assisting a reader in interpreting complex visual patterns. The AI (algorithm) is integrated into the device's digital display, meaning the human interaction is with the "digital display" outcome.

6. Standalone (Algorithm Only) Performance

• The VeriClear™ Digital Early Result Pregnancy Test inherently includes an algorithm within its electronic and optical components to interpret the immunochemical reaction and display "YES+", "NO-", or "?".
• The "Performance Characteristics" section, specifically "Software validation and reader reliable was performed specifically to ensure the performance of VeriClear™ Digital hCG Reader electronic read-out result," indicates that the algorithm's performance was validated.
• The analytical studies (precision, sensitivity, hook effect, interference, specificity for pH/SG/fragments) are essentially evaluations of the standalone performance of the device's integrated algorithm, as these are objective measurements of the device's ability to accurately detect and interpret hCG levels under controlled conditions, without direct human interpretation of a test line.

7. Type of Ground Truth Used

• Quantitative HCG Standards: For analytical performance studies (sensitivity, precision, hook effect, interference, cross-reactivity), the ground truth was established using human urine samples spiked with hCG, traceable to the 4th WHO International Standard. This provides a highly accurate and standardized reference for hCG concentration.
• Predicate Device Comparison: For the method comparison study, the ground truth for clinical samples was established by comparison with a legally marketed predicate device (First Response Digital Early Result Pregnancy Test).
• Quantitative hCG Laboratory Test: For the early pregnancy detection and false-positive rate studies, Microwell Quantitative hCG test was used as a reference for hCG levels, alongside clinical confirmation for positive cases.
• Professional User Interpretation: For the lay user study, interpretation by "professional users" served as the ground truth for the blind hCG samples.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size for a training set. This is common for devices that use established immunochemical principles combined with a digital reader. The "training" of the device's algorithm would likely involve internal development and testing using known reference materials and a diverse set of samples to fine-tune the optical and algorithmic interpretation of the immunoassay results. This data is typically part of the device's design and verification, not usually detailed as a distinct "training set" in an FDA summary unless machine learning is a primary component.

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

• Since a specific "training set" is not detailed, the method for establishing ground truth for any internal development/training related to the algorithm would follow similar principles as the test sets:
  • Known concentrations of hCG samples (WHO International Standard traceability): To teach/calibrate the reader how to interpret different levels of hCG.
  • Diverse urine samples (with varying pH, specific gravity, interferents): To ensure robustness of the algorithm under different physiological conditions.
  • The document states "The VeriClear™ Digital Early Result Pregnancy Test device incorporates electronic and optical components along with a microprocessor and specific algorithms into the plastic housing. VeriClear™ Digital Early Result Pregnancy Test is capable of correctly determining and interpreting the test results correctly..." indicating the algorithm's function, which would have been developed and internally validated using such ground truth methods.

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