(72 days)
The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device are rapid chromatographic immunoassays for the qualitative detection of Amphetamine in urine at a cutoff concentration of 300 ng/mL. These tests are used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for healthcare professionals including professionals at point-of-care sites.
The ACON AMP 300 One Step Amphetamine Test Strip and the ACON AMP 300 One Step Amphetamine Test Device are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Amphetamine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Amphetamine and its metabolite in urine at a cutoff concentration of 300 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 Amphetamine at the concentration 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.
Here's a breakdown of the acceptance criteria and study details for the ACON AMP 300 One Step Amphetamine Test Strip and Test Device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a set of predefined numerical targets for performance metrics. Instead, it presents the results of a clinical evaluation and "demonstrated substantial equivalency" to a predicate device and good agreement with GC/MS. The "acceptance" is implied by the FDA clearance based on these results.
Here's a table based on the demonstrated performance of the device compared to the predicate and GC/MS, which serves as the de facto "met acceptance criteria" based on the FDA's "substantial equivalency" finding.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (ACON AMP 300 One Step Amphetamine Test Strip) | Reported Device Performance (ACON AMP 300 One Step Amphetamine Test Device) |
|---|---|---|---|
| Vs. Predicate Device | |||
| Positive Agreement | High agreement (e.g., >95% with 95% CI) | >99% (97% - 99%)** | >99% (97% - 99%)** |
| Negative Agreement | High agreement (e.g., >95% with 95% CI) | >99% (98% - 99%)** | >99% (98% - 99%)** |
| Overall Agreement | High agreement (e.g., >95% with 95% CI) | >99% (99% - 99%)** | >99% (99% - 99%)** |
| Vs. GC/MS (Ground Truth) | |||
| Positive Agreement | High agreement for positive samples (e.g., >95% with 95% CI) | >99% (125/125) (97% - 99%)** | >99% (125/125) (97% - 99%)** |
| Negative Agreement | High agreement for negative samples (e.g., >95% with 95% CI) | 99% (173/175) (96% - 98%)* | 99% (173/175) (96% - 99%)* |
| Total Agreement | High overall agreement (e.g., >95% with 95% CI) | 99% (298/300) (98%- 99%)* | 99% (298/300) (98% - 99%)* |
*Note: * Denotes 95% confidence interval. ** Since the proportion cannot go above 100%, this is really a 97.5% confidence interval.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 300 clinical urine specimens.
- Data Provenance: The document refers to them as "clinical urine specimens," implying they were collected from human subjects. The country of origin is not specified, but the submission is to the FDA, suggesting samples relevant to the US market or regulatory context. The study is a "clinical evaluation," based on retrospectively collected "clinical urine specimens" compared against a predicate and GC/MS.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This is an analytical chemical method, not human expert interpretation. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically applied to image-based diagnostic AI is not directly applicable here. The expertise lies in operating and interpreting GC/MS results, which is standard practice in toxicology labs.
4. Adjudication Method for the Test Set
The adjudication method involved comparing the results of the ACON AMP 300 tests (Strip and Device) against the results obtained from a FDA-cleared Amphetamine test (the predicate) and Gas Chromatography/Mass Spectrometry (GC/MS) analysis. This indicates a direct comparison and quantitative analysis against established methods, rather than an adjudication process requiring multiple human readers to resolve discrepancies. GC/MS served as the definitive ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was NOT done. This study assesses the performance of a diagnostic device (an Amphetamine test) rather than an AI-assisted interpretation tool for human readers. Therefore, the concept of "how much human readers improve with AI vs. without AI assistance" is not applicable here. The device itself is the diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the primary performance studies described are standalone. The ACON AMP 300 One Step Amphetamine Test Strip and Test Device are designed to be standalone diagnostic tools that provide a visual, qualitative result. The "clinical evaluation" compared the device's output directly against the predicate and GC/MS, without human interpretation of the device being the primary variable being measured or improved. The device itself provides the result.
7. The Type of Ground Truth Used
The primary and most definitive ground truth used was Gas Chromatography/Mass Spectrometry (GC/MS) analysis. The FDA-cleared Amphetamine test also served as a comparative reference.
8. The Sample Size for the Training Set
The document does not specify a separate training set or its sample size. This is common for traditional in vitro diagnostic devices like immunoassay strips, where the "training" (development and calibration) typically occurs during the manufacturing and R&D phase using known standards and internal validation, rather than through a distinct "training set" of clinical data for a machine learning model. The clinical evaluation mentioned uses a "clinical urine specimens" as the test set for validation.
9. How the Ground Truth for the Training Set Was Established
As no separate "training set" with ground truth establishment for a machine learning model is mentioned, this question is not directly applicable in the context of this traditional immunoassay device. The performance characteristics of the device were verified through analytical studies (sensitivity, specificity, cross-reactivity, interference, precision, read time flex, temperature flex, specimen storage and stability) (Page 4), which would have relied on precisely known concentrations of analytes and interferents, not a "ground truth" derived from clinical samples in the same way as a machine learning training set.
§ 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).