(233 days)
The DRI™ Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. The product is intended for use in clinical laboratories only.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
DRI Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL.
DRI Ecstasy Plus Assay is a class assay. Ecstasy drugs represent a group of ring substituted methylenedioxy analogues of amphetamine including 3, 4 methylenedioxyamphetamine (MDA), 3, 4 - methylenedioxymethamphetamine (MDMA) and 3, 4 - methylenedioxyethylamphetamine (MDEA). They are central nervous system (CNS) stimulants popularly abused for their psychotropic effects and are listed by the U.S. Drug Enforcement Administration as Schedule | (no accepted medical application with great abuse potential).
The provided document is a 510(k) Pre-market Notification from the FDA regarding the DRI™ Ecstasy Plus Assay. This is a medical device for in-vitro diagnostics, specifically a homogeneous enzyme immunoassay for detecting ecstasy drugs in human urine. The document mainly focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance characteristics and states the acceptance criteria (stated as "met the acceptance criteria" or specific percentage/range values).
| Performance Characteristic | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Precision (Qualitative) | Assay within run ≤ 2% CV; Total run precision ≤ 5.0 % CV | Assay within run is ≤ 2% CV and total run precision is ≤ 5.0 % CV. |
| Precision (Semi-Qualitative) | Assay within run ≤ 5% CV; Total run precision ≤ 7.5 % CV | Assay within run is ≤ 5% CV and total run precision is ≤ 7.5 % CV. |
| Method Comparison (Negative Sample Agreement) | 100% agreement | 100% in both Qualitative and Semi-Quantitative modes. |
| Method Comparison (Positive Sample Agreement) | 100% agreement | 100% in both Qualitative and Semi-Quantitative modes. |
| Method Comparison (Overall Sample Agreement) | 100% agreement | 100% for DRI Ecstasy Plus assay in both Qualitative and Semi-Quantitative mode. |
| Specificity (Structurally Related Compounds - Positive Result) | Produced a positive result above the cut-off calibrator at lowest concentrations. | Reported at lowest concentrations. |
| Specificity (Structurally Related Compounds - Negative Result) | Produced a negative result below the cut-off calibrator at highest concentrations. | Reported at the highest concentrations. |
| Specificity (Structurally Unrelated Compounds) | Shall produce a negative result below the 500 ng/mL MDMA sample in both Qualitative and Semi-quantitative modes at the concentrations tested. | Produced a negative result below the 500 ng/mL MDMA cutoff when structurally unrelated compounds were spiked into negative pool urine at the tested concentrations. |
| Interference (Qualitative - Low Control) | Rates of low control samples spiked with interfering substances and pH adjusted were negative. | Were negative. |
| Interference (Qualitative - High Control) | Rates of high control samples spiked with interfering substances and pH adjusted were positive. | Were positive. |
| Interference (Semi-quantitative - Low Control Recovery) | Recovery of low control level sample spiked with interfering substances and pH adjusted within 80 - 120% of nominal value of 375 ng/mL. | Within 80 - 120% of the nominal value of 375 ng/mL. |
| Interference (Semi-quantitative - High Control Recovery) | Recovery of high control level sample spiked with interfering substances and pH adjusted within 80 - 120% of nominal value of 625 ng/mL. | Within 80 - 120% of the nominal value of 625 ng/mL. |
| Stability (Open-Vial / In-Use) | Met acceptance criteria. | Demonstrated that three lots met the acceptance criteria. |
| Stability (Unopened Shelf Life) | Stable for 36 months when stored unopened at 2-8°C. | Supports the claim that the kits are stable for 36 months when stored unopened at 2-8°C. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "Negative sample agreement" and "Positive sample agreement" in the method comparison and "structurally unrelated compounds were spiked into negative pool urine at the tested concentrations" for specificity, but no specific numbers of samples are provided.
The data provenance is also not stated. It does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For this type of in-vitro diagnostic device (immunoassay for drug detection), the ground truth is typically established by alternative chemical methods (e.g., GC/MS or LC-MS/MS), not by expert human readers. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical image review is not applicable here. The document states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method."
4. Adjudication Method for the Test Set
Since the ground truth is established by alternative chemical methods like GC/MS or LC-MS/MS, an adjudication method for reconciling expert opinions is not applicable. The result from the confirmatory chemical method serves as the definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This device is an in-vitro diagnostic immunoassay, not an AI-powered diagnostic tool requiring human interpretation or a multi-reader multi-case study. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a sense. The "performance testing" described (Precision, Method Comparison, Specificity, Interference, Stability) represents the standalone performance of the assay itself. The immunoassay provides a direct analytical result (qualitative or semi-quantitative) without human interpretation affecting the primary outcome of detection. The device's output is an objective measurement (e.g., optical density change leading to a positive/negative determination), rather than an image requiring human interpretation.
7. The Type of Ground Truth Used
The type of ground truth used is confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). This is explicitly stated as the "preferred confirmatory method" to obtain a "confirmed analytical result."
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. Immunoassays are typically developed and validated using a series of laboratory experiments with known samples (spiked urine, controls, clinical samples confirmed by reference methods) rather than being "trained" on a dataset in the way an AI algorithm is. The development process would involve optimizing reagents and assay conditions but doesn't usually involve a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set was Established
As there is no mention of a "training set" in the context of an immunoassay, the establishment of its ground truth is not applicable as outlined for AI/ML devices. The "ground truth" for developing and validating such an assay would be established by preparing samples with known concentrations of the target analytes and confirming those concentrations using gold-standard analytical techniques like GC/MS or LC-MS/MS.
§ 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).