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The CEDIA® Cannabinoids OFT Assay is intended for use in the qualitative determination of Cannabinoids in human oral fluid at a cutoff concentration of 3 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against 1-Δ THC and performed on the MGC 240. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA THC OFT Calibrators are intended for use in the calibration of I-Δ THC when used with the CEDIA Cannabinoids OFT Assay. This in vitro diagnostic device is intended for clinical laboratory use only.

The CEDIA Cannabinoids OFT Assay provides only a preliminary analytical test result. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drug of abuse test result particularly when preliminary positive results are used.

Microgenics CEDIA® Cannabinoids OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-aalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously re-associate to form fully active enzyme that, in the assay format, cleave a substrate, generating a color change that can be measured spectrophotometrically.

In the assay, analyte in the sample competes with analyte conjugated to one inactive fragment (enzyme donor) of 0-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragment free to form active enzyme. If the analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the re-association of inactive B-qalactosidase fragments. and no active enzyme is formed. The amount of active enzyme formed and resultant absorbance change are directly proportional to the amount of analyte present in the sample.

The Oral-Eze™ Saliva Collection System consists of Oral-Eze™ saliva collector and collection tube with preservative buffer. Oral-Eze™ saliva collector consists of an absorbent pad attached to a plastic handle. The saliva collector is provided with a volume adequacy indicator. The plastic handle has a round window where blue color will appear when sufficient volume of oral fluid is collected. Samples are collected by placing the collector pad and plastic shield between lower cheek and gum with the plastic shield facing the cheek. Oral fluid collection is done when blue color appears in the window of the handle. The pad is ejected in to the collection tube by placing thumb on the ridges on the handle and pushing the thumb forward. The collection tube is capped and sent to the laboratory for processing and testing.

Acceptance Criteria and Device Performance for CEDIA® Cannabinoids OFT Assay

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not explicitly state the sample size used for the qualitative method comparison test set (comparison with GC/MS). It only reports percentages for concordance, sensitivity, and specificity.

The data provenance is not explicitly mentioned, but given the context of a 510(k) submission to the FDA, it is highly likely that the studies were conducted in a retrospective manner using collected human oral fluid samples. The country of origin of the data is not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not specify the number of experts or their qualifications used to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. The ground truth appears to be established by Gas Chromatography/Mass Spectrometry (GC/MS), which is typically considered a definitive method, minimizing the need for expert adjudication in interpreting the GC/MS results themselves.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an AI-powered image analysis tool or decision support system that would involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

6. Standalone Performance Study

Yes, a standalone performance study was done. The entire summary of clinical testing (Qualitative Precision, Qualitative Cutoff Characterization, Interference, Specificity and Cross-Reactivity, and Qualitative Method Comparison) evaluates the performance of the CEDIA® Cannabinoids OFT Assay as a standalone algorithm (without human-in-the-loop performance). The comparison with GC/MS directly assesses its analytical accuracy.

7. Type of Ground Truth Used (Test Set)

The type of ground truth used for the significant performance metrics (concordance, sensitivity, and specificity) was Gas Chromatography/Mass Spectrometry (GC/MS). The document also mentions Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) as an alternative preferred confirmatory method, implying GC/MS is the primary reference.

8. Sample Size for Training Set

The document does not provide any information about a training set or its sample size. This is typical for traditional in vitro diagnostic assays which are often developed and validated using analytical studies rather than machine learning models that require distinct training and test sets.

9. How Ground Truth for Training Set Was Established

Since no training set is mentioned, information on how its ground truth was established is not provided.

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