(62 days)
The Amedica Drug Screen THC Test is an in vitro diagnostic test for the rapid detection of THC in human urine at a cutoff of 50 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 test cutoff is 50 ng/ml.
Here's a detailed breakdown of the Amedica Drug Screen THC Test's acceptance criteria and the study that proves its performance, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Agreement with GC/MS | Not explicitly stated; implied high agreement | > 96% agreement with GC/MS results |
| Clinical Site Study | Not explicitly stated; implied satisfactory performance for professional use | "demonstrated that Amedica Biotech Drug Screen THC Test can be use by professionals to obtain a visual, qualitative detection of drugs of abuse" |
| Substantial Equivalence | Equivalence to predicate device (Rapid THC Test) | Demonstrated equivalence to the Rapid Diagnostics THC Test |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The text mentions "blind-labeled clinical specimens," but the number of specimens is not provided.
- Data Provenance: The data came from "blind-labeled clinical specimens" and "clinical site study...at two certified laboratories." The country of origin is not specified, but given the FDA submission, it's highly likely to be the USA. The study design is retrospective, as it uses "clinical specimens that have been measured by GC/MS."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a definitive analytical method, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done in the context of improving human reader performance with AI. The device is a standalone immunoassay, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the entire performance evaluation described is for the standalone device. The device is an "immunochromatographic assay for the rapid detection of THC in human urine" that provides a "visual, qualitative detection." Its performance is measured directly against GC/MS. While a human does read the visual result, the "algorithm" here refers to the chemical reaction and visual readout mechanism of the test strip itself, not a separate AI algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The primary ground truth for the correlation study was GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and commonly accepted reference method for confirming the presence and concentration of substances in urine.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Amedica Drug Screen THC Test is a competitive immunoassay, not an AI-based device that requires a training set in the conventional sense. Its "training" is inherent in its chemical design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as it's not an AI-based device. The device itself is designed based on known chemical principles and the specificity of antibodies to THC metabolites.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).