(89 days)
The Amedica Drug Screen Amphetamine Test is a immunochromatographic assay for the rapid detection of Amphetamine in human urine at a cutoff concentration of 1000 ng/ml. This assay has not been evaluated at point-of-care locations and is intended for use by healthcare professionals.
This assay provides only a preliminary result. A more specific alternative chemical method is needed to obtain a confirmed result.
The Amedica Drug Screen Amphetamine Test is an in vitro diagnostic test for the rapid detection of amphetamine in human urine at a cutoff of 1000 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 1000 ng/ml.
Acceptance Criteria and Study for Amedica Drug Screen Amphetamine Test
This document outlines the acceptance criteria for the Amedica Drug Screen Amphetamine Test and the study proving its performance.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Agreement with GC/MS | Not explicitly stated (implied to be high, comparable to predicate) | > 97% |
| Qualitative Detection (Clinical Site Study) | Not explicitly stated (implied to be effective and usable by professionals) | Demonstrated that the device can be used by professionals for visual, qualitative detection of drugs of abuse. |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (Rapid Amphetamine Test - Rapid Diagnostics, Inc.) | Demonstrated substantial equivalence to the predicate device. |
Note: The provided text does not explicitly state numerical acceptance criteria for agreement or qualitative detection. The "Performance" section describes the study results as demonstrating the device meets the intended purpose and is comparable to a predicate.
2. Sample Size and Data Provenance
- Test Set Sample Size: Not explicitly stated. The study used "blind-labeled clinical specimens" and was a "correlation study."
- Data Provenance:
- Country of Origin: Not explicitly stated, but the manufacturer is based in Hayward, CA, and the FDA's address is in Rockville, MD, suggesting a US-centric study.
- Retrospective or Prospective: Not explicitly stated. The use of "blind-labeled clinical specimens" could suggest either if they were collected for another purpose and then retrospectively analyzed, or if they were collected prospectively for this study. The term "correlation study" doesn't clarify this either.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: Not applicable, as the primary ground truth for the correlation study was established by GC/MS, an analytical chemical method, not human interpretation.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by GC/MS, which is an objective chemical analysis, not subject to human adjudication for its results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid diagnostic test with a visual qualitative result, not an image-based or complex diagnostic system typically requiring MRMC studies. The "clinical site study" mentioned involved professionals using the device, but it was to demonstrate usability and qualitative detection, not to measure improvement with AI assistance or compare human readers.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Yes, in essence, the "correlation study using blind-labeled clinical specimens that have been measured by GC/MS" represents a standalone performance evaluation of the device itself. The device is a "membrane based one-step, lateral flow, competitive immunoassay," which operates as a standalone diagnostic without human interpretation beyond reading the visual result. The >97% agreement refers to the device's inherent performance compared to a gold standard.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the primary correlation study was Gas Chromatography/Mass Spectrometry (GC/MS). The text states, "This study produced > 97% agreement with GC/MS results," indicating GC/MS served as the reference standard. This is an objective, highly accurate analytical method for drug detection and quantification in urine.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a chemical immunoassay, not a machine learning or AI-based algorithm that requires a "training set" in the conventional sense. Its design and performance are based on chemical reactions and physical properties.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device. The immunoassay's specificity and sensitivity are inherent to its chemical design.
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).