(90 days)
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
Configuration of the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs oxazepan and oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific altemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test DipCard are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine and Oxycodone, in human urine samples. Healgen Multi-Drug devices detect each of analytes on different strips. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided document describes the Healgen Multi-Drug Urine Test Cup and Healgen Multi-Drug Urine Test Dip Card, which are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, and Oxycodone in human urine.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a table format with corresponding performance metrics like sensitivity, specificity, or accuracy for the device as a whole. Instead, it provides the cut-off levels for each drug, which serve as a critical component of the device's performance specification.
The performance characteristics are implied by the statement: "Based on the test principle and acceptable performance characteristics, it's concluded that the Healgen Multi-Drug Urine Test Cup, and Healgen Multi-Drug Urine Test Dip Card are substantially equivalent to the predicates." This suggests that the device's performance was deemed adequate during verification studies. However, specific values for sensitivity, specificity, etc., for the new multi-drug device are not presented.
A table of the specified cut-off levels is provided in the document:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 ng/mL |
| Oxazepam (OXA) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Morphine (MOR) | 2000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "verification studies" and "interference studies and a lay-user study" were conducted. However, the exact sample size for the test set is not explicitly provided. The data provenance (e.g., country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth for the test set.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The device is a diagnostic test, not an AI-assisted diagnostic tool, so this type of study is not relevant in this context.
6. Standalone (Algorithm Only) Performance Study
As this is a lateral flow immunoassay device, it does not involve algorithms in the sense of AI or software. Therefore, a standalone (algorithm only) performance study is not applicable and not reported. The device's performance is driven by its biological and chemical components.
7. Type of Ground Truth Used
The document states that a "more specific analytical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method." This indicates that chromatography-mass spectrometry (GC/MS or LC/MS) is the intended gold standard/ground truth for confirming the preliminary results of the device. It is highly probable that similar analytical methods were used to establish the ground truth in the verification studies, although not explicitly stated for the studies performed.
8. Sample Size for the Training Set
The document does not mention or specify a training set sample size. As a lateral flow immunoassay device, it does not typically involve machine learning with separate training and testing datasets in the way an AI diagnostic algorithm would. Its development relies on biochemical optimization and validation.
9. How Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of machine learning, the method for establishing its ground truth is not applicable and not described. Ground truth for assay development would typically involve precisely prepared samples with known drug concentrations, confirmed by highly accurate analytical methods like GC/MS or LC/MS.
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).