(104 days)
The CEDIA DAU Opiate 2K Assay is a homogeneous enzyme immunoassay for the qualitative assay of opiates in human urine. Measurements are used in the diagnosis and treatment of opiate use or overdose.
The CEDIA® DAU Opiate 2K Assay is an in-vitro homogeneous enzyme immunoassay used for the qualitative measurement of opiates in urine. It is based on competitive binding concepts employing morphine derivative labeled enzymatic fragments (ß-galactosidase) competing with sample morphine for the morphine-specific antibody. Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Morphine has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Morphine-specific antibody, by binding to the morphine on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of opiates as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG).
Here's a breakdown of the acceptance criteria and study information for the CEDIA DAU Opiate 2K Assay, based on the provided text:
Important Note: This device is a diagnostic assay, not an AI/ML device in the modern sense. Therefore, many of the requested fields (like MRMC study, human readers, training set, experts, etc.) are not applicable and will be marked as such. The study described focuses on analytical performance characteristics rather than clinical diagnostic accuracy with human interpretation.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds that the device must meet to be deemed acceptable. Instead, it presents performance characteristics of the new device (CEDIA DAU Opiate 2K) and compares them to a predicate device (CEDIA DAU Opiate). The implicit acceptance criterion is that the new device performs comparably or acceptably for its intended qualitative use.
| Feature | Acceptance Criteria (Implicit / Contextual) | Reported Device Performance (CEDIA DAU Opiate 2K) |
|---|---|---|
| Precision | Comparable to predicate device across concentration levels. | Within-Run %CV: 1.3% (1500 ng/mL), 1.4% (2000 ng/mL), 1.3% (2500 ng/mL) |
| Total %CV: 4.6% (1500 ng/mL), 5.0% (2000 ng/mL), 4.4% (2500 ng/mL) | ||
| Sensitivity (LOD) | Acceptable for detecting opiates. | 60.9 ng/mL |
| Accuracy | Relative sensitivity comparable to predicate device. | 70.6% of CEDIA DAU Opiate |
| Specificity | 100% relative specificity to predicate device. No significant interference from common substances. | 100% of CEDIA DAU Opiate |
| Interfering substances (Less than 10% error): Glucose=3 g/dL, Chloride=6 g/dL, Protein=0.5 g/dL, Urea=5 g/dL | ||
| Cutoff Level | Defined threshold for qualitative determination. | 2000 ng/mL |
| Major Detectables | Ability to detect key opiate metabolites. | Morphine, Morphine-3-glucuronide, Codeine, Hydrocodone, Hydromorphone, 6 Monoacetylmorphine |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Precision: For each concentration level (1500, 2000, 2500 ng/mL), N=120 for within-run and N=240.1 for total. (Note: "240.1" seems like a typo, likely indicating 240 samples. The value listed under N is 120, then the value again. It's unclear if the 240.1 refers to the total number of measurements or samples, but it's consistent across the concentrations for both devices).
- Sensitivity, Accuracy, Specificity, Interfering Substances, Major Detectables: The document does not explicitly state the sample sizes for these tests.
- Data Provenance: Not specified (e.g., country of origin). Retrospective or prospective is not explicitly stated, but given this is an in-vitro diagnostic device performance study, it is typically a controlled laboratory study measuring analyte concentrations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is an in-vitro diagnostic assay for chemical detection. "Ground truth" is established by laboratory reference methods or known concentrations of analytes, not by expert human interpretation.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or "adjudication" in the context of this chemical assay.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is for evaluating human performance, often with or without AI assistance, in interpreting medical images or clinical data. This device is an in-vitro diagnostic product that directly measures chemical levels.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, this is inherently a standalone performance study. The "device" (CEDIA DAU Opiate 2K Assay) performs the measurement and provides a result (qualitative detection of opiates) without human interpretation in the loop of the assay's function. The results are then read and acted upon by humans, but the assay itself is automated.
7. The Type of Ground Truth Used
The ground truth for this type of assay would be established by:
- Known concentrations: For precision, sensitivity, and accuracy, samples with known, spiked concentrations of opiates.
- Spiked samples or reference methods: For specificity and interfering substances, samples spiked with various compounds or urine samples previously characterized by highly accurate reference methods (e.g., GC/MS).
8. The Sample Size for the Training Set
Not applicable. This device is a chemical immunoassay, not an AI/ML algorithm that requires a "training set" in the computational sense. Its chemistry is developed through laboratory research and optimization, not machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this type of device.
§ 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).