(290 days)
The CEDIA® Opiate OFT Assay is intended for use in the qualitative determination of opiate in human oral fluid at a cutoff concentration of 30 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against morphine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Opiate 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® Opiate OFT Assay uses recombinant DNA technology to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme ß-galactosidase, 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 β-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 β-galactosidase 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.
This document describes the acceptance criteria and the study performance for the CEDIA® Opiate OFT Assay, a device intended for the qualitative determination of opiates in human oral fluid.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Qualitative Precision | Samples below cutoff read negative; samples above cutoff read positive. Accurately recover results. | All samples tested recovered accurately. Samples below cutoff read as negative, and samples above cutoff read as positive. |
| Qualitative Cutoff Characterization | Low control read negative; high control read positive. Accurately recover results. | All samples tested recovered accurately. Low control as negative and high control level as positive. |
| Interference | No significant interference from endogenous and exogenous substances. | No significant interference from endogenous and exogenous substances at specified concentrations and pH. |
| Specificity/Cross-Reactivity | No significant cross-reactivity with structurally unrelated compounds. | No significant cross-reactivity observed with structurally unrelated compounds. |
| Overall Concordance (vs. GC/MS) | High overall concordance with GC/MS (specific threshold not explicitly stated but implied by "substantial equivalence"). | 97.6% overall concordance between CEDIA® Opiate OFT Assay and GC/MS. |
| Sensitivity (vs. GC/MS) | High sensitivity (specific threshold not explicitly stated). | 100.0% sensitivity. |
| Specificity (vs. GC/MS) | High specificity (specific threshold not explicitly stated). | 95.2% specificity. |
Note: The document implies acceptance criteria based on the reported "accurate" recovery and "no significant" interference/cross-reactivity, along with high concordance/sensitivity/specificity values.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size for the "test set" used in the method comparison study. It only mentions "The overall concordance between the CEDIA® Opiate OFT Assay and GC/MS is 97.6%."
Data Provenance: The document does not specify the country of origin of the data. It is a retrospective study comparing the new assay's results against a confirmatory method (GC/MS).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This device is an in vitro diagnostic (IVD) assay, not an imaging or interpretation device that typically relies on human experts for ground truth establishment in the same way clinical diagnostic studies might.
For IVD assays like this, the "ground truth" for the test set is established by a confirmatory analytical method, in this case, Gas Chromatography/Mass Spectrometry (GC/MS). Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as it would apply to interpretive tasks (e.g., radiologists reading images) is not directly applicable here. The experts involved would be the laboratory personnel performing and interpreting the GC/MS results, who are qualified to operate and interpret results from such sophisticated analytical equipment.
4. Adjudication Method for the Test Set
Not applicable. As described above, the ground truth is established by a confirmatory analytical method (GC/MS), not by human expert consensus or adjudication in the traditional sense. Discordant results between the CEDIA® Opiate OFT Assay and GC/MS would be resolved by the GC/MS result, which is considered the "gold standard" for confirmation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic assay, and its performance is evaluated based on its analytical characteristics and concordance with a reference method, not human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was done. The study assesses the performance of the CEDIA® Opiate OFT Assay itself, comparing its results directly to the GC/MS confirmatory method without human interpretation as an intermediate step. The assay provides a "preliminary analytical test result" which then requires confirmation by GC/MS or LC-MS/MS.
7. The Type of Ground Truth Used
The type of ground truth used is confirmatory analytical testing, specifically Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "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."
8. The Sample Size for the Training Set
The document does not provide information about a "training set" or "training data" in the conventional sense used for machine learning algorithms. This is an immunoassay, and its development involves analytical validation, not a distinct training phase with a labeled dataset in the way AI/ML devices do. The performance characteristics are established through various analytical studies (precision, cutoff characterization, interference, specificity, method comparison).
9. How the Ground Truth for the Training Set was Established
Not applicable. As mentioned above, this is an immunoassay and does not have a "training set" in the context of machine learning. The assay mechanism is based on biochemical reactions and genetic engineering (recombinant DNA technology), not on learning from a dataset.
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).