(176 days)
Applied DNA Technologies ACCUSTEP DOA Panels are rapid chromatographic The immunoassays for the qualitative and simultaneous detection of one to ten of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Calibrator | Cutoff Concentration |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 ng/ml |
| Barbiturate | BAR | Secobarbital | 300 ng/ml |
| Benzodiazepines | BZO | Oxazepam | 300 ng/ml |
| Cocaine | COC | Benzoylecgonine | 300 ng/ml |
| Marijuana | THC | 11-nor- $\Delta^9$ -THC9-COOH | 50 ng/ml |
| Methamphetamine | MET | Methamphetamine | 1000 ng/ml |
| Methadone | MTD | Methadone | 300 ng/ml |
| Morphine | MOR | Morphine | 2000 ng/ml |
| Phencyclidine | PCP | Phencyclidine | 25 ng/ml |
| Nortriptyline | NOR | Nortriptyline | 1000 ng/ml |
These test kits are intended for health care professional use only.
This assay provided 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 / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are 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 indicated.
One-step, colloidal gold based chromatographic immunoassay for the rapid, qualitative detection of Marijuana. Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline, a Tricyclic Antidepressant, in human urine.
The ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels are rapid chromatographic immunoassays designed for the qualitative and simultaneous detection of various drugs in human urine. The study presented supports the device's substantial equivalence to predicate devices and GC/MS methodology.
Here's an analysis of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the "Overall Agreement" reported against GC/MS analysis. While specific numerical acceptance criteria (e.g., "must achieve >95% overall agreement") are not explicitly stated, the presented performance data demonstrates high agreement with the gold standard.
| Analyte | Acceptance Criteria (Implied) | Reported Device Performance (Overall Agreement with GC/MS) |
|---|---|---|
| Amphetamine | High agreement with GC/MS | 98.1% (101/103) |
| Barbiturate | High agreement with GC/MS | 98.0% (96/98) |
| Benzodiazepines | High agreement with GC/MS | 93.9% (93/99) |
| Cocaine | High agreement with GC/MS | 98.2% (108/110) |
| Methamphetamine | High agreement with GC/MS | 98.3% (113/115) |
| Morphine | High agreement with GC/MS | 98.1% (103/105) |
| Methadone | High agreement with GC/MS | 98.1% (103/105) |
| Phencyclidine | High agreement with GC/MS | 98.9% (93/94) |
| Nortriptyline | High agreement with GC/MS | 96.8% (92/95) |
| Marijuana (THC) | High agreement with GC/MS (or >92% correlation with predicate) | 97.5% (119/122) |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the test set vary by analyte, ranging from 94 to 122 clinical urine specimens.
- AMP: 103 samples (48 positive, 55 negative)
- BAR: 98 samples (46 positive, 52 negative)
- BZO: 99 samples (43 positive, 56 negative)
- COC: 110 samples (56 positive, 54 negative)
- MET: 115 samples (63 positive, 52 negative)
- MOR: 105 samples (41 positive, 64 negative)
- MTD: 105 samples (51 positive, 54 negative)
- PCP: 94 samples (46 positive, 48 negative)
- NOR: 95 samples (38 positive, 57 negative)
- THC: 122 samples (62 positive, 60 negative)
The data provenance is stated as "blind-labeled clinical specimen correlation study" using "clinical urine specimens." The country of origin is not specified, but the submission is to the US FDA, implying that the specimens would be relevant to the US population or a general population. This is a retrospective study using previously collected clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for the test set was established using Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) as the "preferred confirmatory method." These are analytical chemical methods, not human expert evaluations for establishing ground truth in this context. Therefore, human experts were not used to establish the ground truth for the test set; rather, a laboratory analytical method was used.
4. Adjudication Method for the Test Set
No adjudication method for the test set is mentioned, as the ground truth was established by analytical chemical methods (GC/MS or LC/MS), not by human expert consensus that would require 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
This device is a rapid diagnostic immunoassay for drug detection, not an AI-powered image analysis system or a device that directly assists human readers in interpreting complex cases. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the performance study directly evaluates the "ACCUSTEP DOA Screening Panels vs. GC/MS Analysis," which represents the standalone performance of the device without human interpretation or intervention in the analytical result. The device itself produces a "qualitative and simultaneous detection" result, which is then compared to the GC/MS result. Health care professionals interpret this result, but the study focuses on the device's accuracy in detecting the drug.
7. The Type of Ground Truth Used
The type of ground truth used is analytical chemical confirmation via Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or its sample size. This is typical for immunoassay submissions where the device's analytical performance is evaluated rather than an AI model's learning phase. The "performance characteristics... were evaluated in the laboratory settings and in the blind-labeled clinical specimen correlation study" implies an evaluation of the final product, not a training phase.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned for an AI model, the method for establishing its ground truth is not applicable. The device's underlying immunoassay technology does not involve machine learning that requires a separate training set in the conventional sense.
§ 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).