(28 days)
The Instant-View™ Multi-Drug Screen Urine Test is a qualitative immunoassay intended to be used to detect any combination (variants from 2 to 12) of the following drugs and/or drug metabolites in human urine at the specified cutoff levels. It is intended for professional use only.
| Drug | Cutoff Level (ng/ml) |
|---|---|
| Amphetamine (AMP) | 1000 |
| Barbiturate (BAR) | 200 |
| Benzodiazepine (BZD) | 300 |
| Cocaine (COC) | 300 |
| Marijuana (THC) | 50 |
| Methadone (MTD) | 300 |
| Methamphetamine (METH) | 1000 |
| Methamphetamine (METH) | 500 |
| Morphine (MOR) | 300 |
| Morphine (MOR) | 2000 |
| Phencyclidine (PCP) | 25 |
Instant-View™ Multi-Drug Screen Urine Test provides only a preliminary analytical test result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/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.
The Instant-View™ Multi-Drug Screen Urine Test device is an assemblage of single test devices. It works similarly as the single devices because each device functions independently, but conveniently provides the detection of multiple drugs instead of only one in the same time frame. All the devices are based on the same immunochemical principle of recognition and formation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Instant-View™ Multi-Drug Screen Urine Test:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy percentages) that the device must meet to be considered effective. Instead, the study's acceptance is based on the device being "substantially equivalent" to previously cleared single-drug test devices.
The reported device performance, however, is broadly described:
| Drug | Cutoff Level (ng/ml) | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Amphetamine (AMP) | 1000 | Based on substantial equivalence to single-drug tests | "each device performed normally" and "no interference was observed between different single test devices" |
| Barbiturate (BAR) | 200 | ||
| Benzodiazepine (BZD) | 300 | ||
| Cocaine (COC) | 300 | ||
| Marijuana (THC) | 50 | ||
| Methadone (MTD) | 300 | ||
| Methamphetamine (METH) | 1000 | ||
| Methamphetamine (METH) | 500 | ||
| Morphine (MOR) | 300 | ||
| Morphine (MOR) | 2000 | ||
| Phencyclidine (PCP) | 25 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the performance testing. It mentions "in-house evaluation" but provides no details on the number of samples or their origin. Therefore, the data provenance (e.g., country of origin, retrospective or prospective) cannot be determined from the provided text.
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 to establish a ground truth for the performance testing. The study focuses on demonstrating substantial equivalence to existing single-drug tests, and it's implied that the performance of those predicate devices served as the benchmark.
4. Adjudication Method for the Test Set
No adjudication method is described, as there is no mention of expert review or consensus for establishing ground truth within the context of this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This document describes a diagnostic device for drug screening, not an AI-assisted diagnostic system. Therefore, an MRMC comparative effectiveness study involving 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
The device itself is a standalone immunoassay test; it's not an algorithm. The performance described is its inherent analytical performance. The document doesn't detail performance in terms of typical diagnostic metrics for such devices (e.g., sensitivity, specificity) but rather asserts its performance relative to existing single-drug tests.
7. The Type of Ground Truth Used
The ground truth for the performance of the modified multi-drug screen is implicitly based on the established performance of the individual, 510(k)-cleared Instant-View™ single test devices for each drug. The logic is that if the assembled multi-drug device performs like the individual components without interference, then its performance is considered equivalent to the well-characterized performance of those components. The document implies that Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method for any preliminary positive results from the test, suggesting GC/MS is the ultimate "ground truth" for confirming drug presence in clinical practice, though not explicitly an internal ground truth for the study validating the multi-drug device itself.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning. For this immunoassay device, the "training" would have been the development and optimization of the individual single-drug test components, which are already 510(k) cleared. No specific sample size for this developmental process is provided.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the typical sense for this device, there's no description of how ground truth for such a set was established. The focus is on the substantial equivalence of the combined device to its individual, pre-cleared components.
§ 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).