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The RapidFRET Oral Fluid Assay for MDMA is a homogeneous time-resolved fluorescence assay that is intended for prescription use in central laboratories only on the RapidFRET Integrated Workstation. The assay is used to perform a qualitative screen for Methylenedioxymethamphetamine at 50 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or required. Professional judgment should be applied to any drug test result, particularly when using preliminary positive results. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid MDMA Calibrator Set and RapidFRET Oral Fluid MDMA Control Set are intended for use only with the RapidFRET Oral Fluid Assay for MDMA and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to determine the cutoff level and translate the assay measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid Assay for MDMA is an In Vitro Diagnostic competitive immunoassay used to detect MDMA in human oral fluid. This is a ready-to-use homogenous system that involves energy transfer between an acceptor fluorophore labeled to an antibody and a donor fluorophore labeled to drug. The assay is based on competition between drug in the sample and drug labeled with the donor fluorophore for a fixed number of binding sites on the antibody reagent. When acceptor and donor fluorophores are brought into close proximity through a binding event, energy transfer occurs. The fluorescence resonance energy transfer (FRET) signal is measured at the wavelength of the acceptor fluorophore and is inversely proportional to the amount of drug in the sample. A Cutoff Calibrator is used to translate the sample measurement into a positive result. Controls are used to establish and monitor precision and accuracy.

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1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the expected results and agreement percentages reported.

*Note: The 97% for MS NEG agreement is calculated from the provided table: 200 RapidFRET NEG when MS NEG, and 6+ RapidFRET POS when MS NEG (false positives). So, 200 / (200 + 6) = 200/206 ≈ 97%.

2. Sample Sizes and Data Provenance

• Precision and Analytical Sensitivity Test Set:
  • Sample Size: 279 at 0%, 279 at 25%, 278 at 50%, 279 at 75%, 279 at 100%, 278 at 125%, 263 at 150%, 294 at 175%, 278 at 200% of cutoff. These were spiked oral fluid pools.
  • Data Provenance: Not explicitly stated, but likely laboratory-prepared samples. It doesn't specify country of origin or if it's retrospective/prospective.
• Correlation with MS Quantitation Test Set:
  • Sample Size: 325 neat oral fluid samples.
  • Data Provenance: Collected from "volunteers potentially positive and negative for MDMA." This suggests prospective collection for the purpose of the study. Country of origin not specified, but the applicant's address is in California, USA, making it probable the study was conducted there.
• Cross Reactivity and Analytical Specificity Test Set:
  • Sample Size:
    • Structurally related compounds: A library of over 170 compounds. Specific numbers of samples per compound are not given, but they were spiked into neat oral fluid aliquots (likely 0, 25, 75 ng/mL MDMA).
    • Common substances: Not specified per substance, but implied to be multiple (volunteers for some, spiked aliquots for others).
  • Data Provenance: Laboratory-prepared samples (spiked) and samples from volunteers.

3. Number of Experts and Qualifications for Ground Truth

• Precision and Analytical Sensitivity: No human experts were explicitly mentioned for ground truth. The ground truth was established by the known concentrations of MDMA spiked into the oral fluid pools.
• Correlation with MS Quantitation: The ground truth was established by GC/MS or LC/MS/MS results. No human experts are mentioned for interpreting these confirmatory tests, as they are analytical methods providing quantitative results.
• Cross Reactivity and Analytical Specificity: No human experts were explicitly mentioned. The ground truth was based on the known concentrations of MDMA and cross-reactants spiked into the samples, or the known consumption of common substances.

4. Adjudication Method for the Test Set

• Precision and Analytical Sensitivity: Not applicable, as samples were spiked at known concentrations.
• Correlation with MS Quantitation: Not applicable. GC/MS or LC/MS/MS provides a definitive analytical result, not a judgment requiring adjudication.
• Cross Reactivity and Analytical Specificity: Not applicable. Ground truth was based on known concentrations.

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

• No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, not a medical imaging or interpretive device that typically involves human readers in this context. It performs a qualitative screen (positive/negative) based on a cut-off.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

• Yes, the studies presented are all standalone performance studies. The RapidFRET Oral Fluid Assay for MDMA is an automated laboratory assay that performs a qualitative screen without human interpretation involved in the direct result generation. The performance metrics (precision, analytical sensitivity, correlation with MS) directly reflect the algorithm's performance.

7. Type of Ground Truth Used

• Precision and Analytical Sensitivity: Known concentrations of spiked MDMA (analytical truth).
• Correlation with MS Quantitation: Confirmed analytical results by GC/MS or LC/MS/MS (gold standard analytical truth).
• Cross Reactivity and Analytical Specificity: Known concentrations of spiked compounds (analytical truth) and known consumption of common substances (experiential/known truth).

8. Sample Size for the Training Set

• The document does not specify a separate training set or its sample size. This type of immunoassay device is typically developed through chemical and biological experimentation to establish reagent formulations and cutoff values, rather than through machine learning training on a large dataset in the way a modern AI algorithm would be. The experiments described appear to be validation/verification studies.

9. How Ground Truth for the Training Set Was Established

• As no training set is explicitly mentioned, the establishment of ground truth for it is not described. The device's operational parameters (e.g., cutoff) would be derived from laboratory experiments during development.

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