DAT Oral Fluid Amphetamine (OFAMP) is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine in human oral fluid at a cutoff concentration of 120 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Intercept® Oral Specimen Collection Device. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program and to estimate a dilution of the specimen for confirmation by a confirmatory method such as LC/MS/MS.

DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The Oral Fluid DAT Control Set B is for use as assayed controls with the DAT Oral Fluid assays on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The Oral Fluid DAT Qual Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept® Oral Specimen Collection Device.

The Oral Fluid DAT SQ Cal B calibrators are designed for the calibration of oral fluid assays for drugs of abuse on automated clinical chemistry analyzers for human oral fluid samples collected with the Intercept Oral Specimen Collection Device.

The DAT oral fluids assays are based on the kinetic interaction of microparticles in a solution (KIMS) technology. The DAT oral fluids assays are qualitative and semi-quantitative. In the absence of sample drug, soluble drug conjugates bind to antibody-bound microparticles, causing formation of particle aggregates. As the aggregation reaction proceeds in the absence of sample drug, the absorbance increases. When an oral fluid sample contains the drug in question, this drug competes with the drug derivative conjugate for microparticle-bound antibody. Antibody bound to sample drug is no longer available to promote particle aggregation, and subsequent particle lattice formation is inhibited. The presence of sample drug diminishes the increasing absorbance in proportion to the concentration of drug in the sample. Sample drug content is determined relative to the value obtained for a known cutoff concentration of drug.

Multi-analyte calibrator and control solutions are prepared from NIST traceable, commercially available solutions. A stock solution is prepared gravimetrically and verified by LC/MS/MS. The product calibrators are prepared gravimetrically in a synthetic oral fluid matrix at the following concentrations: 0, 20, 40, 80, 160, and 320 ng/mL. Controls are prepared gravimetrically in a synthetic oral fluid matrix at concentrations ±50% of the cutoff. All calibrator and controls concentrations are verified by LC/MS/MS.

The provided text describes the "DAT Oral Fluid Amphetamine Assay" for the qualitative and semiquantitative detection of amphetamine in human oral fluid. It focuses on the device's intended use and substantial equivalence to a predicate device, but does not contain the specific details about acceptance criteria, a study that proves the device meets those criteria, or information about sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will, however, extract what information is available and indicate where information is missing.

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" through a table or specific percentage/thresholds for performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself. It only defines the cutoff concentration and the intended use.

1. Table of acceptance criteria and the reported device performance

Since explicit acceptance criteria are not provided in the document, I cannot create a table directly. The key performance aspect mentioned is the detection cutoff, which is fundamental to the assay's function.

Missing Information: The document does not provide a study with specific results (e.g., sensitivity, specificity, accuracy, precision data) that would demonstrate the device meets performance acceptance criteria. It focuses on the device's design and intended use for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Missing Information: The document does not mention any sample sizes for test sets, data provenance (country of origin), or whether any studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Missing Information: The document does not describe any test set, experts, or their qualifications.

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

Missing Information: No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that involves human readers interpreting results in an MRMC study. The "AI" component is irrelevant in this context.

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

The device is an in vitro diagnostic assay. Its performance is inherent to its chemical/biological reaction and instrumental measurement. As such, it operates "standalone" in the sense that once the oral fluid is introduced to the assay, the chemical reaction and measurement yield a result without constant human intervention in the result generation process itself, though human interpretation of that result is required.

However, the document does not describe a specific "standalone performance study" with detailed metrics. It states: "DAT Oral Fluid Amphetamine provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method." This indicates that the device is intended to operate as a standalone screening tool, but its results are preliminary and require confirmation by a "gold standard" method.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document states: "Chromatography/mass spectrometry is the preferred confirmatory method." This implies that LC/MS/MS (Liquid Chromatography/Mass Spectrometry/Mass Spectrometry) serves as the "ground truth" or "gold standard" confirmatory method for drug presence and concentration.

The calibrators and controls used for the assay are also "verified by LC/MS/MS" which means LC/MS/MS is used to establish the true concentrations for these reference materials.

8. The sample size for the training set

Missing Information: The document does not mention any training sets or their sample sizes. This type of information is typically relevant for machine learning or AI-based devices, which this assay is not.

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

Missing Information: As no training set is mentioned, the method for establishing its ground truth is also not provided.

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