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The RapidFRET Oral Fluid Assay for OPIATES 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 Opiates at 40 ng/mL in neat oral fluid samples collected with the RapidEASE Oral Fluid Collector. This assay is calibrated against Morphine. This assay provides only a preliminary result. To obtain a confirmed analytical result, a more specific alternate chemical method such as GC/MS or LC/MS/MS is 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 Calibrator Set and RapidFRET Oral Fluid Control Set are intended for use only with the RapidFRET Oral Fluid Assay for OPIATES and samples collected with the RapidEASE Oral Fluid Collector. The cutoff calibrator is used to translate the sample measurement into a positive or negative result. The positive and negative controls are used to monitor laboratory systems, operators, precision, accuracy and assay conditions. For In Vitro Diagnostic Use Only.

The RapidFRET Oral Fluid Assay for Opiates is provided in an all liquid, ready to use format. Two reagents are provided included a drug specific reagent and a second competitive donor reagent. The kit is provided with reagents and microtiter plates. A Cutoff Calibrator is used to translate the sample measurement into a positive or negative result. Controls are used to establish and monitor precision and accuracy. Calibrators and controls are sold separately.

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided 510(k) summary for the RapidFRET Oral Fluid Assay for OPIATES:

Acceptance Criteria and Device Performance Study

The RapidFRET Oral Fluid Assay for OPIATES is a qualitative screening device intended to detect opiates in oral fluid. The acceptance criteria and supporting studies focus on the analytical performance of the device, particularly its precision, correlation with confirmatory methods, and analytical specificity (cross-reactivity).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this diagnostic device are implied through the performance observed in the studies designed to demonstrate substantial equivalence to the predicate device. The key performance characteristics evaluated were precision (analytical sensitivity), correlation with mass spectrometry (GC/MS or LC/MS/MS), and cross-reactivity/analytical specificity.

• 0-75% of cutoff (0-30 ng/mL): 100% Negative (0% Positive)
• 125-200% of cutoff (50-80 ng/mL): 100% Positive (0% Negative)
• 100% of cutoff (40 ng/mL): 66% Positive, 34% Negative
  Conclusion: Analytical sensitivity is between 75% and 125% of cutoff, with expected results achieved at 100% frequency. |
  | Correlation with Confirmatory Methods (Accuracy) | High agreement between the device's screening results and a more specific alternate chemical method (GC/MS or LC/MS/MS) for both positive and negative samples, particularly within the clinically relevant concentration ranges. | Correlation Results (n=245 samples):
• Overall Agreement for Positive Samples (RapidFRET): >98% agreement with GC/MS or LC/MS/MS.
• Overall Agreement for Negative Samples (RapidFRET): 100% agreement with GC/MS or LC/MS/MS.
• Discordant Results: One sample was Positive by RapidFRET (Total Opiates = 36.5 ng/mL by LC/MS, where cutoff is 40 ng/mL). |
  | Analytical Specificity (Cross-Reactivity) | The device should not show significant cross-reactivity with structurally unrelated compounds or common substances/interferents at clinically relevant concentrations that would lead to false positive or false negative results, while appropriately reacting with structurally related opiate compounds. | Cross-Reactivity Results:
• Evaluated with 167 compounds (structurally related/unrelated, metabolites, OTC/prescription meds, drugs of abuse).
• 29 structurally related compounds cross-reacted below 30,000 ng/mL in the absence of morphine.
• 12 of these cross-reacted at 1000 ng/mL equivalence or less.
• Interference Study: Common substances (foods, dental products, pH, etc.) did not interfere, showing NEG results at 20 ng/mL Morphine and POS results at 60 ng/mL Morphine. |

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

• Precision/Analytical Sensitivity Test Set: For precision, samples were created by spiking negative oral fluid pools with Morphine at various concentrations (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, and 200% of the 40 ng/mL cutoff). Three lots of the assay were run four times daily for a minimum of 20 days.
  • The total number of individual runs/data points (N) per concentration level varied from 263 to 294 (e.g., N=279 for 0% and 25%, N=278 for 50%, N=279 for 75%, N=279 for 100%, N=278 for 125%, N=263 for 150%, N=294 for 175%, N=278 for 200%).
  • Data Provenance: Retrospective, as negative oral fluid pools were "spiked" to create controlled samples. The origin of the negative oral fluid pools is not explicitly stated (e.g., country of origin, volunteer demographics).
• Correlation with MS Quantitation Test Set:
  • Sample Size: 245 neat oral fluid samples from volunteers potentially positive and negative for opiates.
  • Data Provenance: Prospective, as samples were collected from volunteers and then tested. The origin of the volunteers (e.g., country) is not specified. The samples were handled in a blinded and randomized manner for instrument operators.
• Cross-Reactivity and Analytical Specificity Test Set:
  • Sample Size: 167 different compounds (for cross-reactivity). For interference, common substances were tested (specific number of substances not explicitly stated, but includes HSA, ethanol, baking soda, whole blood, hemoglobin, hydrogen peroxide, sodium chloride, cholesterol, denture adhesive, ascorbic acid, bilirubin, lgA, lgG, IgM; various pH values; and items like mouthwash, cough syrup, etc., tested after volunteers used them).
  • Data Provenance: Retrospective for the spiked compound library. For common substances, it involved volunteer participation (prospective for the collection part for some items) and then spiking or testing original samples.

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

• Precision/Analytical Sensitivity: The ground truth was established by precise spiking concentrations of Morphine into negative oral fluid pools. No human experts were involved in establishing this analytical ground truth.
• Correlation with MS Quantitation: The ground truth was established by confirmatory testing using GC/MS or LC/MS/MS. These are highly accurate analytical methods considered the gold standard for drug confirmation. The document does not specify the number or qualifications of the analysts performing the GC/MS or LC/MS/MS.
• Cross-Reactivity/Analytical Specificity: The ground truth was established by the known concentration of the spiked compounds and the known presence/absence of morphine. No human experts were involved in establishing this analytical ground truth.

4. Adjudication Method for the Test Set

• Precision/Analytical Sensitivity, Cross-Reactivity/Analytical Specificity: No adjudication method was mentioned as these were analytical studies with predefined concentrations and expected outcomes.
• Correlation with MS Quantitation: The comparison was directly between the RapidFRET assay results and the established gold-standard GC/MS or LC/MS/MS results. The text implies a direct comparison rather than an adjudication process involving multiple human reviewers for interpretation.

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

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, where the output is typically a quantitative or qualitative (positive/negative) result generated by an instrument. The studies focus on the analytical performance of the assay itself, not on how human readers interpret images or data with or without AI assistance.

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

Yes, the studies presented are standalone performance studies of the RapidFRET Oral Fluid Assay for OPIATES. The device is intended for use in central laboratories, and the performance characteristics (precision, correlation with MS, cross-reactivity) are evaluated for the assay system itself, without an explicit "human-in-the-loop" component altering the assay's direct output. The assay provides a preliminary result, and a human professional interprets the results and applies judgment, but this is post-analysis, not part of the primary device performance evaluation described here.

7. The Type of Ground Truth Used

• Precision/Analytical Sensitivity: Spiked concentrations (known amounts of opiate in negative matrix).
• Correlation with MS Quantitation: Confirmatory analytical methods (GC/MS or LC/MS/MS) results.
• Cross-Reactivity/Analytical Specificity: Known concentrations of spiked compounds and known presence/absence of morphine.

8. The Sample Size for the Training Set

The document does not specify a separate training set for the device. As an immunoassay (competitive homogeneous immunoassay), the "training" (development and optimization) would involve biochemical and chemical engineering processes, often using various concentrations of analytes and interferents during the assay's development prior to validation. The studies described are validation and verification studies using manufactured products.

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

Since no explicit training set is described in the context of machine learning or AI, the concept of ground truth for a training set in this biological assay context refers to the controlled conditions and known spiking concentrations used during the assay's development and optimization phase. This would typically involve:

• Precisely prepared calibrators and controls: Manufactured with known concentrations of the target analyte (Morphine) to set the assay's detection limits and cutoff.
• Reference materials: Use of pure chemical standards for opiates and potential interferents.
• Known negative and positive samples: Prepared by either ensuring the absence of the analyte or by spiking known concentrations into a verified negative matrix.

These known values guide the formulation and calibration of the assay reagents and the setting of the cutoff level for discriminating positive from negative results.

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