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MissLan® Pregnancy Rapid Test (Strip) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

MissLan® Pregnancy Rapid Test (Midstream) is used for qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, as an aid in early detection of pregnancy. It is intended for use by people who would like to find out whether they are pregnant in a home environment. Only for use outside the body. For over the counter use.

MissLan® Pregnancy Rapid Test will be sold in Midstream and Strip format. The Midstream format consists of a single test strip assembled in a plastic housing, with an absorbent tip, and is designed to be tested in dip or midstream mode. The Strip format is a single test strip. The Midstream format contains one Test Midstream sealed in a desiccated aluminum pouch and Instructions for Use. The Strip format contains one Test strip sealed in a desiccated aluminum pouch, Urine Collection Cup and Instructions for Use. The device is in a ready-to-use format and does not require assembly before use.

Here is a summary of the acceptance criteria and study details for the MissLan® Pregnancy Rapid Test (Strip) and MissLan® Pregnancy Rapid Test (Midstream), based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Analytical Performance (Precision/Reproducibility/Sensitivity):

  • For each hCG concentration (0, 12.5, 15, 18.75, 22.5, 25, 50, 100, 200 mIU/mL), 10 replicates were tested per day for 5 days for each of 3 device lots. This means 50 tests per operator/lot/concentration.
  • Total tests for Strip format: 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total tests for Midstream format (in-stream): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total tests for Midstream format (dip): 9 concentrations * 50 replicates/operator * 3 operators = 1350 tests.
  • Total for Sensitivity: 4050 unique test interpretations.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples.

• Specificity (Cross-reactivity with non-pregnant samples):

  • Sample Size: 450 urine samples (150 from pre-menopausal, 150 from peri-menopausal, 150 from post-menopausal women).
  • Each age group had 50 participants tested with strip, 50 with midstream (dip), and 50 with midstream (in-stream).
  • Data Provenance: Not explicitly stated but implies prospective collection of urine from normal, non-pregnant females.

• Method Comparison Study:

  • Sample Size: 200 urine samples (approximately half suspected pregnant, most in early stage < 5 weeks).
  • Data Provenance: Collected from women presenting to test for pregnancy, likely prospective clinical samples. The samples were split to test different device formats:
    • Strip Device: 200 samples (101 positive, 99 negative)
    • Midstream Device (in-stream method): 100 samples (52 positive, 48 negative)
    • Midstream Device (dip method): 100 samples (49 positive, 51 negative)

• Lay Person Study:

  • First Study (Self-testing vs. Professional): 200 women.
    • Strip device: 100 women (52 positive, 48 negative)
    • Midstream device (in-stream): 50 women (26 positive, 24 negative)
    • Midstream device (dip): 50 women (23 positive, 27 negative)
  • Second Study (Spiked Samples): 200 laypersons.
    • 100 laypersons tested 5 mIU/mL hCG aliquots.
    • 100 laypersons tested 25 mIU/mL hCG aliquots.
  • Data Provenance: Collected from individuals with varying educational and occupational backgrounds from three sites, presumably prospective.

3. Number of Experts and Qualifications for Ground Truth

• Analytical Performance: The ground truth for spiked samples was based on the known, precisely controlled concentration of hCG, traceable to the 5th WHO International Standard. The "operators" (presumably laboratory technicians or trained personnel doing the reading) were involved in testing, but the ground truth for the hCG concentration itself was intrinsic to the sample preparation.
• Method Comparison Study: The ground truth was established by testing the same samples with a predicate device. While not explicitly stated as "experts," the "three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site)" implies trained professionals made the readings for both the candidate and predicate devices. No specific qualifications (e.g., years of experience) are provided.
• Lay Person Study (First Study): The ground truth was established by "professional testing" of the same urine samples. It can be inferred that these were qualified laboratory personnel or healthcare professionals. No specific number or qualifications are provided beyond "professional."
• Lay Person Study (Second Study): The ground truth was the known, precisely controlled concentration of hCG in the blindly labeled spiked samples (0 mIU/mL for 5 mIU/mL hCG aliquot which should be negative, and 25 mIU/mL hCG aliquot which should be positive according to the device's cut-off).

4. Adjudication Method for Test Set

• Analytical Performance (Reproducibility): No explicit adjudication method is mentioned beyond testing by "three different operators." The data is presented as raw counts of negative/positive readings per operator/lot, not as an adjudicated consensus.
• Method Comparison Study: The comparison was made directly between the candidate device and the predicate device results for each sample. Implicitly, any disagreement would be noted, but the results show 100% conformity, suggesting no need for complex adjudication.
• Lay Person Study (First Study): The layperson's self-test results were compared directly against the "professional" results. No explicit adjudication process for discrepancies is described, though the 100% concordance implies disagreements were not observed or not significant enough to warrant further mention.
• Lay Person Study (Second Study): The layperson's results were compared to the known spiked hCG concentration (the "true" positive or negative result). No explicit adjudication process is detailed.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance.
• This device is a rapid diagnostic test for home use (Over-The-Counter). The studies focus on analytical performance, comparison to a predicate device, and the ability of laypersons to correctly use and interpret the device (without assistance). There is no "AI assistance" component to this device.

6. Standalone (Algorithm Only) Performance

• Yes, a standalone (algorithm only) performance equivalent was performed in the context of the device itself (without human-in-the-loop assistance for interpretation beyond reading the visual line).
• The entire analytical performance section (sensitivity, hook effect, specificity, cross-reactivity, interfering substances, pH, density) evaluates the device's inherent capability to detect hCG under various conditions. The "reading" is visual, which is the intended standalone function for an OTC rapid test. The "operators" in these studies are effectively performing the standalone reading as intended by the device's design.

7. Type of Ground Truth Used

• Known Spiked Concentrations: For analytical sensitivity, hook effect, cross-reactivity, interfering substances, pH, and density studies, the ground truth was based on precisely prepared urine samples with known concentrations of hCG or other substances.
• Predicate Device Results: For the method comparison study, the results from a legally marketed predicate device served as the reference standard (ground truth).
• Professional Testing: For the first layperson study, the results from trained professionals using the MissLan® Pregnancy Rapid Test served as the ground truth against which layperson self-test results were compared.

8. Sample Size for Training Set

• The provided document describes a 510(k) summary for device clearance, which typically focuses on validation studies rather than a detailed breakdown of the development or training process.
• No information is provided regarding the specific sample size used for a "training set" for the development of MissLan® Pregnancy Rapid Test. This is typical, as the 510(k) submission generally presents the results of validation testing for the final device, not the iterative development data.

9. How Ground Truth for Training Set Was Established

• No information is provided on how the ground truth for a "training set" was established for this device, as the document does not detail the development phase.
• Given that this is an immunochromatographic rapid diagnostic test, the "training" aspect would primarily relate to optimizing reagent concentrations, membrane characteristics, and buffer systems to achieve the desired analytical performance (e.g., sensitivity, specificity, read time) based on known hCG concentrations and interfering substances. The establishment of ground truth would follow standard laboratory practices for preparing calibrated samples and verifying analytical properties of the reagents.

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