Search Results

The RapidFRET Oral Fluid Assay for Amphetamine 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 amphetamine 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 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 Amphetamine Calibrator Set and RapidFRET Oral Fluid Amphetamine Control Set are intended for use only with the RapidFRET Oral Fluid Assay for Amphetamine 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 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 Amphetamine is an In Vitro Diagnostic competitive immunoassay used to detect amphetamine 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 or negative result. Controls are used to establish and monitor precision and accuracy.

The provided document describes the RapidFRET Oral Fluid Assay for Amphetamine and its performance characteristics. Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

The document implicitly defines acceptance criteria through the performance study results. While specific percentage targets aren't always explicitly stated as "acceptance criteria," the reported performance demonstrates what the device achieved and, by extension, what was considered acceptable for substantial equivalence.

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

• Precision Test Set Sample Size:
  • 3 lots were analyzed, 4 times daily, for a minimum of 20 days.
  • For each concentration level tested (0%, 25%, 50%, 75%, 100%, 125%, 150%, 175%, 200% of cutoff), the "N" value represents the total number of tests performed. These ranged from 263 to 294 for each concentration, across all lots.
• Correlation with MS Test Set Sample Size:
  • N = 415 neat oral fluid samples.
• Cross-Reactivity and Analytical Specificity Test Set Sample Size:
  • Approximately 167 different structurally related and unrelated compounds were tested.
  • Additional common substances (HSA, ethanol, baking soda, etc.), pH variations, and oral products (antiseptic mouthwash, coffee, etc.) were also tested individually or through volunteer samples.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective bench testing and clinical sample testing performed specifically for this submission. The "Correlation with MS Quantitation" study mentions samples collected "from volunteers potentially positive and negative for amphetamine."

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

The document does not mention the use of experts to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method involving experts for interpretation of results. For the Correlation with MS Quantitation study, the "ground truth" was established by confirmatory testing using more specific alternate chemical methods such as GC/MS or LC/MS/MS.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, where the output is a qualitative (positive/negative) result based on a measurement against a specific cutoff, not a diagnostic image or interpretation requiring multiple human readers.

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done

Yes, the studies presented describe the standalone performance of the RapidFRET Oral Fluid Assay for Amphetamine. The performance metrics (precision, accuracy, cross-reactivity, analytical specificity) are derived directly from the assay's output based on given samples, without human interpretation influencing the result. The device provides a "preliminary result," which then requires a human to potentially send the sample for confirmatory testing, but the performance data outlined specifically relates to the device's ability to generate that preliminary result.

7. The Type of Ground Truth Used

• Precision and Analytical Sensitivity: Controlled spiking of known concentrations of amphetamine into negative oral fluid pools.
• Correlation with MS Quantitation: Confirmatory analytical methods: GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry). This represents a highly specific and accurate chemical analysis, often considered the "gold standard" for drug confirmation.
• Cross-Reactivity and Analytical Specificity: Controlled spiking of known concentrations of interfering substances into oral fluid samples with and without amphetamine, and analysis of oral fluid from volunteers after exposure to common oral products.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" as it would be understood for machine learning algorithms. This device is an immunoassay, which typically does not involve a separate training phase like AI/ML models. Its operational parameters are determined during assay development and validation, not through iterative training on a dataset.

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

As there is no explicit "training set" mentioned in the context of an AI/ML model, this question is not directly applicable. The performance characteristics are established through the validation studies described, which include controlled spiking experiments and correlation with a gold standard method.

Ask a specific question about this device