(219 days)
"STARTOX" Drugs of Abuse Screening Test is a one-step lateral flow immunoassay intended for the simultaneous detection of multiple drug analytes in urine. "STARTOX" is 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 |
|---|---|---|
| Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml |
| Opiates (morphine) | OPI | 300 ng/ml |
| Cocaine (benzoylecgonine) | COC | 300 ng/ml |
| Cannabinoids | ||
| (11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml |
STARTOX™ 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.
For professional use only.
A lateral flow immunoassay for the detection of drugs of abuse.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
Acceptance Criteria and Device Performance
The document states that the STARTOX™ Drugs of Abuse Screening Test is substantially equivalent to a legally marketed predicate device. The performance is assessed by comparison to other approved devices (Medtox Profile II and RDS 9) and subsequently confirmed to be substantially equivalent.
Table of Acceptance Criteria and Reported Device Performance:
| Compound | Abbreviation | Level (Acceptance Criterion) | Reported Device Performance |
|---|---|---|---|
| Methamphetamine ((+/-)methamphetamine HCl) | METH | 1000 ng/ml | Performed substantially equivalent to the legally marketed device against the stated level. |
| Opiates (morphine) | OPI | 300 ng/ml | Performed substantially equivalent to the legally marketed device against the stated level. |
| Cocaine (benzoylecgonine) | COC | 300 ng/ml | Performed substantially equivalent to the legally marketed device against the stated level. |
| Cannabinoids (11-nor-Δ9-THC-9-carboxylic-acid) | THC | 50 ng/ml | Performed substantially equivalent to the legally marketed device against the stated level. |
Note: The acceptance criteria for the STARTOX™ device are implicitly its ability to detect the specified compounds at the listed SAMHSA recommended levels with comparable performance to the predicate devices. The study concludes that the device performed substantially equivalent to the legally marketed predicate devices, thereby meeting the acceptance criteria of being comparable in performance.
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: 90 samples were tested against each drug (4 drugs), consisting of 50 negative and 40 positive specimens. This means a total of 90 samples per drug, so 90 x 4 = 360 individual tests were performed across the four drugs.
- Data Provenance: Not explicitly stated, but typically for in vitro diagnostic device studies, samples would be collected from a relevant population (e.g., clinical samples, drug screening samples). It is retrospective as the "drug status of these samples was tested by EMIT and quantified by GC/MS," indicating these were pre-existing samples with established ground truth. The country of origin is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as expert consensus was not the primary method for establishing ground truth.
- Qualifications of Experts: Not applicable.
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Adjudication method for the test set:
- Adjudication Method: Not applicable. The ground truth was established by quantitative analytical methods rather than expert adjudication.
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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:
- MRMC Study: No, this was not a MRMC study. This device is a lateral flow immunoassay for in vitro diagnostic use, not an AI-assisted diagnostic tool requiring human reader interpretation in the context of an MRMC study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, the study evaluates the performance of the STARTOX™ device directly, comparing its results to established analytical methods and predicate devices. This represents its standalone performance. The device provides a "preliminary qualitative test result" which is then confirmed by other methods, implying its standalone role as a screening tool.
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The type of ground truth used:
- Ground Truth Type:
- EMIT (Enzyme Multiplied Immunoassay Technique): A commonly used immunoassay for drug screening, often considered a good initial positive/negative indicator.
- GC/MS (Gas Chromatography/Mass Spectrometry): Stated as the "preferred confirmatory method" and used for quantification. GC/MS is widely considered the gold standard for drug confirmation due to its high specificity and sensitivity.
- Therefore, the ground truth was established using a combination of a commonly accepted screening method (EMIT) and the gold standard analytical method (GC/MS) for quantification and definitive drug status.
- Ground Truth Type:
-
The sample size for the training set:
- Training Set Sample Size: Not applicable. This document describes a performance validation study for an immunoassay, not a machine learning model that requires a distinct training set.
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How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of a machine learning model.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).