(59 days)
The ACON® mAMP 500 One Step Methamphetamine Test Strip and Test Device are rapid immunochromatographic assays for the qualitative detection of methamphetamine, a central nervous stimulating drug, in urine. Measurements obtained by these devices are used in the diagnosis and treatment of methamphetamine use or overdose.
This assay provides only a preliminary result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method.
The ACON mAMP-500 One Step Methamphetamine Test Strip and ACON mAMP-500 One Step Methamphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Methamphetamine in a urine sample. The test is based on the principle of antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Methamphetamine and its metabolite in urine at a cutoff concentration of 500 ng/mL. These tests can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Methamphetamine at the concentration i below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
This document describes the acceptance criteria and study results for the ACON® mAMP-500 One Step Methamphetamine Test Strip and Test Device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through comparison to a predicate device and against a gold standard (GC/MS). The tables below summarize the performance for both the Test Strip and Test Device. Given that the acceptance criteria are not explicitly stated as numerical targets in the document beyond general agreement with a predicate and GC/MS, the "Target Performance" column reflects inferred expectations for high agreement.
ACON mAMP-500 One Step Methamphetamine Test Strip Performance
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (95% CI) |
|---|---|---|
| Positive Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 99% (97% - 100%) |
| Negative Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 80% (73% - 85%) |
| Overall Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 87% (83% - 91%) |
| Positive Agreement vs. GC/MS | High agreement (especially for >+25% Cutoff) | 100% (140/140) (97% - 100%) |
| Negative Agreement vs. GC/MS | High agreement (especially for Negative) | 97% (153/160) (91% - 98%) |
| Total Agreement vs. GC/MS | High agreement | 98% (95% - 99%) |
ACON mAMP-500 One Step Methamphetamine Test Device Performance
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (95% CI) |
|---|---|---|
| Positive Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 100% (97% - 100%) |
| Negative Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 82% (76% - 87%) |
| Overall Agreement vs. FDA-cleared mAMP 500 Test | High agreement | 89% (84% - 92%) |
| Positive Agreement vs. GC/MS | High agreement (especially for >+25% Cutoff) | 99% (139/140) (96% - 99%) |
| Negative Agreement vs. GC/MS | High agreement (especially for Negative) | 98% (156/160) (94% - 99%) |
| Total Agreement vs. GC/MS | High agreement | 98% (96% - 99%) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 300 clinical urine specimens.
- Data Provenance: Clinical urine specimens. The country of origin is not specified, nor is whether the data was retrospective or prospective, though "clinical evaluation was conducted" implies prospective collection for the study. Approximately 10% of specimens contained methamphetamine concentration between -25% cutoff to +25% cutoff range, indicating a focus on the diagnostic gray zone.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis, which is an analytical chemical method, not by human experts. Therefore, the concept of "number of experts" and their qualifications as typically applied to medical imaging or diagnostics read by humans does not directly apply here.
4. Adjudication Method for the Test Set
Not applicable as the ground truth was established by an objective analytical method (GC/MS), not by human interpretation or adjudication.
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, an MRMC comparative effectiveness study was not done. This device is a rapid chromatographic immunoassay that provides a visual, qualitative end result, and does not involve AI or human readers interpreting complex data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance data presented is for the device in its standalone capacity (algorithm only, as it's an immunoassay that produces a direct result), compared against a predicate device and GC/MS. The "human-in-the-loop" aspect is limited to reading a visual result (presence or absence of a colored line).
7. The Type of Ground Truth Used
The primary ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an objective, highly specific, and sensitive analytical method considered the gold standard for confirming drug presence and concentration in toxicology.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its size. This is typical for simple immunoassay devices which are developed and validated, rather than "trained" in the machine learning sense. The clinical evaluation data (300 specimens) serves as the validation/test set for the device's performance.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is mentioned in the context of machine learning, this question is not applicable. The device's underlying immunoassay principles are based on established antibody-antigen reactions, not a data-driven training process. The accuracy of the device is assessed against GC/MS as the gold standard in a clinical evaluation.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).