(290 days)
The CEDIA® Cocaine OFT Assay is intended for use in the qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL in neat oral fluid. The specimen must be collected exclusively with the Oral-Eze™ Saliva Collection System. The assay is calibrated against benzoylecgonine and performed on the MGC240. This in vitro diagnostic device is intended for clinical laboratory use only.
The CEDIA Cocaine 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.
The CEDIA® Cocaine OFT Assay uses recombinant DNA technology (US Patent No. 4708929) to produce a unique homogeneous enzyme immunoassay system. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments i.e., enzyme acceptor (EA) and enzyme donor (ED). These fragments spontaneously reassociate to form fully active enzyme that, in the presence of cocaine or cocaine metabolites, will have reduced activity due to competition for binding sites.
The CEDIA® Cocaine OFT Assay is an in vitro diagnostic device intended for qualitative determination of cocaine in human oral fluid at a cutoff concentration of 15 ng/mL using the Oral-Eze™ Saliva Collection System on the MGC240. The assay provides a preliminary analytical test result, requiring a more specific alternative method like GC/MS or LC-MS/MS for confirmation.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria with numerical targets for sensitivity, specificity, or concordance. Instead, it presents the "Method Comparison" results as the primary performance metrics. The implicit acceptance criterion appears to be "high concordance" with the confirmatory method (GC/MS).
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Concordance with GC/MS | High Concordance | 97.6% |
| Sensitivity (vs. GC/MS) | High Sensitivity | 97.6% |
| Specificity (vs. GC/MS) | High Specificity | 97.6% |
| Qualitative Precision | Samples cutoff read positive | All samples tested recovered accurately |
| Qualitative Cutoff Characterization | Low control negative; High control positive | All samples tested recovered accurately |
| Interferences | No significant interference | No significant interference from endogenous and exogenous substances or pH range (5-9) |
| Specificity and Cross-Reactivity | No significant cross-reactivity with unrelated compounds | No significant cross-reactivity observed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample size used for the method comparison study. It only mentions "All samples tested" for qualitative precision and cutoff characterization, which is not a specific number.
The data provenance is not explicitly stated regarding country of origin. The study appears to be a retrospective comparison, as it's comparing the device's results to a confirmatory method (GC/MS) implying the samples were processed and analyzed. There is no indication of a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing the ground truth. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS), which is a laboratory analytical method, not human expert consensus.
4. Adjudication Method for the Test Set
Since the ground truth was established by a laboratory analytical method (GC/MS) rather than human interpretation, an adjudication method for human readers is not applicable and therefore not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The study focuses on the standalone performance of the assay compared to a gold standard analytical method.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study was performed. The "Method Comparison" directly assesses the performance of the CEDIA® Cocaine OFT Assay itself (the "device") against the GC/MS reference method. The assay produces a preliminary analytical test result without direct human interpretation being part of its core performance measurement in this context. While clinical consideration and professional judgment are mentioned for the use of the preliminary positive results, the performance metrics (sensitivity, specificity, concordance) are purely for the device's analytical capability.
7. Type of Ground Truth Used
The type of ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS). This is a highly accurate and preferred confirmatory analytical method for drug testing, essentially serving as an objective "gold standard" for the presence or absence of cocaine.
8. Sample Size for the Training Set
The document does not specify the sample size for any training set. As this is an immunoassay, the "training" analogous to machine learning would typically involve assay development and optimization using characterized samples, but this is not detailed.
9. How the Ground Truth for the Training Set Was Established
The document provides no information on how the ground truth for any training set was established. The focus of the provided text is on the performance evaluation of the final commercialized assay.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).