(273 days)
First Sign™ Drugs of Abuse Screening Test are one-step lateral flow immunoassays intended for the detection of drug analytes in urine. First Sign™ Drug of Abuse Screening Test are intended for use in the qualitative detection of drugs of abuse at the following Substance Abuse Mental Health Services Administration (SAMHSA) recommended levels:
| Compound | Abbreviation | Level |
|---|---|---|
| Amphetamine (d-amphetamine sulfate) | AMP | 1000 ng/ml |
| Methamphetamine ((+)methamphetamine HC1) | METH | 1000 ng/ml |
| Opiates 2000 (morphine-3-P-D glucuronide) | OPI | 2000 ng/ml |
| Opiates 300 (morphine-3-P-D glucuronide) | OPI | 300 ng/ml |
| Cocaine (Benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids (11-nor-A9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
| Phencyclidine (phencyclidine HC1) | PCP | 25 ng/ml |
First Sign™ Drugs of Abuse Screening Test provide only a preliminary qualitative test result. Use a more specific alternate quantitative analytical method to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Apply clinical and professional judgment to any drug of abuse test result, particularly when preliminary positive results are obtained.
A lateral flow immunoassay for the detection of drugs of abuse.
The provided text describes the First Sign Drug of Abuse Screening Test, a lateral flow immunoassay for detecting drugs in urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabular format with specific numerical targets. However, the performance claim serves as the de facto acceptance criterion.
| Compound | Abbreviation | SAMHSA Recommended Level (Cut-off) (Acceptance Criteria for Detection) | Reported Device Performance (Specificity/Sensitivity vs. Predicate + GC/MS) |
|---|---|---|---|
| Amphetamine | AMP | 1000 ng/ml | >97% |
| Methamphetamine | METH | 1000 ng/ml | >97% |
| Opiates 2000 | OPI | 2000 ng/ml | >97% |
| Opiates 300 | OPI | 300 ng/ml | >97% |
| Cocaine | COC | 300 ng/ml | >97% |
| Cannabinoids | THC | 50 ng/ml | >97% |
| Phencyclidine | PCP | 25 ng/ml | >97% |
Note: The SAMHSA recommended levels are the cut-off thresholds for qualitative detection, meaning the device should detect the drugs at or above these concentrations. The ">97%" performance refers to the device's accuracy (likely a combination of sensitivity and specificity, though not explicitly broken down) when compared to both a legally marketed predicate device and GC/MS.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: 60 positive samples and 60 negative samples were tested against each drug. Since there are 7 drugs listed, the total number of tests performed would be (60 positive + 60 negative) * 7 drugs = 840 tests.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be a retrospective comparison, as samples were collected and then tested against existing methods.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of "experts" in the traditional sense of medical professionals interpreting results for the ground truth.
- The ground truth was established by Gas chromatography/mass spectrometry (GC/MS), which is described as the "preferred confirmatory method." GC/MS is a laboratory analytical technique, not an expert human interpretation.
4. Adjudication Method for the Test Set:
- There was no explicit adjudication method described by multiple human readers. The primary comparison was against a predicate device and GC/MS.
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 standalone immunoassay device, not an AI-assisted diagnostic tool for human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, a standalone study was performed. The "First Sign™ Drug of Abuse Screening Test" is a standalone device (a lateral flow immunoassay) that provides a preliminary qualitative result without human-in-the-loop interpretation being part of its core performance evaluation in this context. The results of the immunoassay are visually interpreted, but the study focuses on the device's ability to accurately detect the analytes compared to established methods.
7. The Type of Ground Truth Used:
- The primary ground truth used was Gas chromatography/mass spectrometry (GC/MS). This is considered an objective and highly accurate analytical method for confirming the presence and concentration of drugs of abuse.
8. The Sample Size for the Training Set:
- The document describes a performance evaluation, not a machine learning study involving a "training set." Therefore, there is no training set sample size mentioned. The immunoassay is a chemical/biological assay, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established:
- As there was no training set, this question is not applicable.
§ 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).