(105 days)
The Redi-Test Opiates is a qualitative, one step, immunochromatographic competitive assay used to screen human urine for the presence of the opiate compounds including morphine at a cut off concentration of 300 ng/mL. The test is qualitative and provides only a preliminary analytical result, which must be confirmed by an alternate methodology preferably, GC/MS.
The Redi-Test Opiates is an immunochromatograpic based one step in vitro test.
Acceptance Criteria and Device Performance Study for Redi-Test Opiates
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Correlation with predicate device (DRI, Opiate Enzyme Immunoassay) | >99% correlation |
| Detection of morphine and codeine at 300 ng/mL cutoff | Detected (Implied by substantial equivalence to predicate) |
| Qualitative preliminary analytical result | Qualitative preliminary analytical result |
| Requires confirmation by alternate methodology (e.g., GC/MS) | Requires confirmation by alternate methodology (e.g., GC/MS) |
2. Sample Size and Data Provenance
The study used 100 specimens, consisting of 50 negative and 50 positive samples, covering the entire assay range. The provenance of this data (e.g., country of origin, retrospective or prospective) is not specified in the provided document.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts, nor their qualifications, used to establish the ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set. The comparison appears to be a direct correlation between the Redi-Test Opiates and the predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed. The study described focused on the correlation of the Redi-Test Opiates with a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study was performed. The Redi-Test Opiates is an immunochromatographic assay, which is a standalone in vitro diagnostic device, not an algorithm requiring human-in-the-loop for its primary performance. The study evaluated the device's performance in detecting opiates in urine samples.
7. Type of Ground Truth Used
The ground truth for the test set was established by the results obtained from the predicate device, the DRI, Opiate Enzyme Immunoassay. This is an indirect ground truth based on the performance of an already legally marketed and accepted device. The document also states that confirmation by an alternate methodology, preferably GC/MS, is required for both the predicate and the Redi-Test, implying that GC/MS would be the ultimate gold standard for confirmation, but it was not used to establish the ground truth for the comparison study itself.
8. Sample Size for the Training Set
The document does not provide information regarding a separate training set. The study described focuses on the comparison of the Redi-Test Opiates to a predicate device using test specimens. As an immunoassay, the device itself is not "trained" in the typical machine learning sense.
9. How Ground Truth for the Training Set was Established
Since no training set is described, this information is not applicable based on the provided document. The device's underlying principles are based on known immunochromatographic reactions, not on learning from a training 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).