(55 days)
The Amedica Drug Screen Opiate Test is an in vitro diagnostic test for the rapid detection of morphine in human urine at a cutoff of 2000 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use. It is not intended for over the counter sale.
This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
Membrane based one-step, lateral flow, competitive immunoassay use colloidal gold for visual detection. The cutoff is 2000 ng/ml.
Here's a summary of the acceptance criteria and the study details for the Amedica Drug Screen Opiate Test, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Agreement with GC/MS (Gold Standard) | > 97% agreement with GC/MS results |
| Visual, qualitative detection by professionals in clinical settings | Demonstrated by clinical site study at two certified laboratories |
| Substantial equivalence to predicate device (Rapid Diagnostics Opiate Test) | Demonstrated by comparison with the predicate kit |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated, but the "correlation study" used "blind-labeled clinical specimens." The clinical site study was performed at "two certified laboratories." The specific number of samples is not provided.
- Data Provenance: "Clinical specimens." The origin country is not specified, but the manufacturer is based in California, USA, and the FDA approval is for the US market. The study appears to be retrospective as it uses "blind-labeled clinical specimens," implying pre-existing samples.
3. Number of Experts and Qualifications for Ground Truth
This information is not provided in the text. The ground truth method (GC/MS) doesn't typically involve human expert interpretation in the same way an imaging study would. The second part of the assessment involved observations by "professionals" at certified laboratories, but the number and qualifications of these individuals are not detailed for establishing ground truth specifically.
4. Adjudication Method for Test Set
This information is not applicable in the traditional sense for this type of test (chemical analysis vs. imaging interpretation). The ground truth was established by GC/MS, which is an objective chemical measurement, not requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed as described. This type of study typically involves multiple human readers interpreting results with and without AI assistance to measure improvement in diagnostic performance. This device is a standalone diagnostic test, and the human role is to visually read the result, not actively interpret complex data.
6. Standalone Performance
Yes, a standalone performance evaluation was completed. The "correlation study" using GC/MS and the clinical site study demonstrate the performance of the device itself (algorithm only, in the context of chemical detection). The test is designed to provide a "visual, qualitative detection" directly from the device.
7. Type of Ground Truth Used
The primary ground truth used was Gas Chromatography-Mass Spectrometry (GC/MS). The text states: "The product performance was evaluated by correlation study using blind-labeled clinical specimens that have been measured by GC/MS." GC/MS is a highly accurate analytical method often considered the gold standard for drug detection and quantification.
8. Sample Size for Training Set
The text does not provide information on the sample size used for a training set. As this is a lateral flow immunoassay, it's a chemical and physical device, not an AI/machine learning algorithm that typically requires a discrete training set in the same manner. The design and validation largely focus on the chemical and physical properties and their interaction with the sample.
9. How Ground Truth for Training Set Was Established
This information is not applicable/not provided for the same reasons as point 8. The "training" of such a device is through its chemical formulation and manufacturing processes to achieve the desired sensitivity and specificity, not through explicit data training with a labeled dataset in the way a software algorithm would be trained.
§ 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).