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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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TrueDx™ hCG Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case 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.

VeriClear™ Early Result Pregnancy Test (Midstream & Cassette Formatographic immunoassay for qualitative detection of human chorionic (hCG) in urine, as an in aid in early detection of pregnancy, in some case 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.

TrueDX™ hCG Early Result Pregnancy Test is designed to be tested in midstream and cassette mode. Each of the devices (Cassette and Midstream), contains a pouch with the test and instructions for use. The cassette and midstream nitrocellulose test strips are contained in a plastic housing. The cassette test also contains a dropper.

TrueDX™ hCG Early Result Pregnancy Test is a qualitative lateral flow immunoassay for the detection of hCG. The device comes in two formats: Cassette and Midstream. Each device includes a pouch with the all components to perform the test, instruction for use and a desiccant package to control the moisture during the storage of the test kit. The cassette and midstream nitrocellulose test strips are mounted in a plastic housing. The cassette test, which is designed to be used as prescription use contains a dropper pipette.

The VeriClear™ Early Result Pregnancy Test and TrueDX™ hCG Early Result Pregnancy Test are the same devices, except the device names and intended use population.

The provided document is a 510(k) Summary for the TrueDX™ hCG Early Result Pregnancy Test and VeriClear™ Early Result Pregnancy Test, which are qualitative chromatographic immunoassays for the detection of human chorionic gonadotropin (hCG) in urine. The document details the device's performance characteristics, including analytical and clinical studies.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied rather than explicitly stated as quantitative targets in a table within this summary document for certain aspects. However, for analytical sensitivity, a clear target is indicated. For other performance metrics, the "acceptance" is demonstrated by the reported results showing highly accurate and consistent performance, often achieving 100% agreement or detection at specified levels.

Here's a table summarizing the acceptance criteria (inferred or explicitly stated) and the reported device performance:

2. Sample sizes used for the test set and data provenance:

• Precision/Reproducibility:
  • Across Lots: 250 replicates per hCG level per lot (10 replicates/run x 5 operators x 5 days). Total of 750 replicates per hCG level for 3 lots.
  • Across Operators: 150 replicates per hCG level per operator (from the above dataset).
• Within-Lot Reproducibility: 20 replicates for each hCG level.
• Analytical Sensitivity: 15 replicates per hCG concentration per lot. Total of 45 replicates per hCG concentration for 3 lots.
• Analytical Specificity (Interference): At least 2 replicates (implied by "2 different lots") per substance for negative and 10 mIU/ml hCG samples. ("All samples were tested in replicates of 5 for each format" is also stated later, suggesting maybe 5 replicates per lot per sample type.)
• Cross-reactivity: Replicates for each substance (number not explicitly stated, but "tested by two operators with two lots of the test kit for each format" implies multiple tests). For hyper-glycosylated hCG, 5 replicates per hCG concentration for 3 different lots.
• pH/Specific Gravity/Hook Effect/β-core Fragment: Replicates tested (number not always explicitly stated, but implied as sufficient for robust testing). For hook effect, 3 lots tested by 2 operators.
• Method Comparison with Predicate Device: 166 urine samples from women at physician offices.
• Clinical Samples (Early Pregnancy Detection): 616 urine samples from 56 different women.
• Lay User Study:
  • Actual Urine: 218 females tested their own urine (110 Midstream, 108 Cassette). 9 pregnant, 101 non-pregnant for Midstream/Midstream-Dip; 6 pregnant, 102 non-pregnant for Cassette.
  • Spiked Urine: 53 samples at each hCG level for Midstream, 57 for Midstream-Dip, and 110 for Cassette.
• Specificity Study (False Positives in Non-Pregnant Women): 320 non-pregnant women (100 pre-menopausal, 111 peri-menopausal, 109 post-menopausal).

Data Provenance:
The document does not explicitly state the country of origin for the data. The studies are described as internal performance evaluations. While patient samples were collected from "physician offices" and "women who planned to become pregnant," the document doesn't specify if these were prospective or retrospective collections, though the early pregnancy detection study following women throughout their conception cycles sounds prospective for that specific cohort. The lay user study involved participants with diverse backgrounds recruited specifically for the study, suggesting a prospective design for that component.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The document describes the device as measuring hCG levels, where hCG is a biological marker. Ground truth for hCG levels in urine samples for the analytical studies (precision, sensitivity, specificity) was established by spiking known concentrations of hCG standard traceable to the WHO 4th International Standard, or by using known negative urine samples. These are objective, quantitative measures rather than observer-dependent expert interpretations.

For the method comparison study, the predicate device was presumably used as the reference standard, and the results of both the candidate and predicate devices were compared. The text states "Urine samples were collected from 166 women at physician offices for pregnancy testing," and the samples were "masked and randomized." All samples were tested by "two different health care professionals." Their specific qualifications are not detailed beyond "health care professionals."

For the clinical sample (early pregnancy detection) study, samples were collected from women followed throughout their conception cycles. The ground truth for pregnancy status and relative timing to the expected menstrual period (EMP) would be clinical, likely based on confirmed pregnancy outcomes and menstrual cycle tracking. The document implies that the detection rate is against the true biological state rather than expert interpretation of the test result itself.

For the lay user study, professional users also tested aliquots of the same urine samples as a reference for comparison, implying their results served as a ground truth for interpretation consistency. Their qualifications are not specified beyond "professional."

For the specificity study to determine false-positive rates, an "ELISA quantitative analyzed hCG level test kit" was used as the reference method ("ground truth") to confirm hCG levels, and subjects with positive results on the new device or hCG levels >5.00 mIU/ml on ELISA were referred for "clinical confirmation of positive." This implies a multi-modal ground truth involving an objective lab assay and clinical follow-up.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in image-based AI studies where human interpretation is the primary ground truth. This is an hCG urine test kit.

• For analytical studies, the "ground truth" is the known spiked concentration or the characterized negative sample. No adjudication is needed as the result is objectively positive/negative based on the strip's reaction.
• For the precision study, multiple operators tested replicates, and the results were aggregated to calculate reproducibility (e.g., % positive). This is a statistical aggregation, not adjudication.
• For the method comparison study, each sample was tested by "two different health care professionals." It's not stated whether there was an adjudication rule if their interpretations differed; given it's a qualitative test (positive/negative), disagreements would likely be rare or require re-testing/third party confirmation. The 100% agreement reported suggests no significant discrepancies needed formal adjudication.
• For the lay user study, lay user results were compared to professional user results. Discrepancies (e.g., 8 lay users positive vs. 9 professional positive for 7.0mIU/ml, or 30 vs 32 for 8.5mIU/ml) are simply reported as the difference in numbers/percentages, indicating performance deviation, not an adjudication process to force agreement.

Therefore, formal adjudication as typically understood in reader studies was not applicable or explicitly described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size:

No, an MRMC study was not done. MRMC studies are primarily for evaluating the impact of AI on human reader performance in diagnostic imaging by measuring reader accuracy with and without AI assistance across multiple cases and readers. This document describes a standalone in-vitro diagnostic (IVD) test kit, not an AI-powered diagnostic tool for human interpretation.

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

Yes, the device is inherently a standalone chemical assay that produces a visual result. The various analytical and clinical studies described (precision, sensitivity, specificity, early pregnancy detection with clinical samples, false-positive rate) demonstrate the "algorithm only" performance (i.e., the device's performance as an assay) without human-in-the-loop assistance influencing the outcome of the test itself. The lay user study primarily evaluates ease of use and interpretation accuracy by lay users rather than an assisted vs. unassisted performance comparison.

7. The type of ground truth used:

• Analytical Studies (Precision, Sensitivity, Specificity): Primarily known spiked concentrations of hCG standard (traceable to WHO 4th International Standard) in negative human urine, and characterized negative urine samples. This is a form of reference standard/laboratory-defined ground truth.
• Method Comparison: Comparison against a legally marketed predicate device (FIRST RESPONSE Early Result Pregnancy Test) on collected urine samples. The predicate device's result serves as the de-facto ground truth for equivalence.
• Early Pregnancy Detection Clinical Samples: Likely clinical confirmation of pregnancy (e.g., blood tests, ultrasound, follow-up) and menstrual cycle tracking for timing relative to the expected period. This is based on outcomes data/clinical truth.
• Lay User Study: Comparison against results obtained by professional users testing aliquots of the same samples (both actual and spiked urine). This is a consensus or expert interpretation ground truth for comparing interpretational consistency.
• Specificity Study (False Positives in Non-Pregnant Women): Quantitative ELISA hCG level test kit results and subsequent clinical confirmation for any elevated hCG or positive results. This combines a laboratory assay ground truth with clinical confirmation/outcomes data.

8. The sample size for the training set:

This document describes a 510(k) submission for a traditional in-vitro diagnostic test kit (lateral flow immunoassay) based on chemical reactions and visual interpretation. It is not an AI/ML-based device, and therefore, there is no "training set" in the context of machine learning. The development of such a device involves iterative R&D, chemical formulation, and design, but not data-driven algorithmic training.

9. How the ground truth for the training set was established:

As there is no AI/ML training set, this question is not applicable to the described device.

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