(413 days)
Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Polymed Therapeutics Fastep Dipcard Drugs of Abuse Screen Device are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to seven of the following drugs in a variety of combinations in human urine. The cutoff concentrations and direct calibrator for these drugs are as follows:
| Analyte | Abbreviation | Direct Calibrator | Cutoff (ng/mL) |
|---|---|---|---|
| Amphetamine | AMP | Amphetamine | 1000 |
| Benzodiazepines | BZO | Oxazepam | 300 |
| Cocaine | COC | Benzoylecgonine | 300 |
| Marijuana | THC | 11-nor-Δ9-THC9-COOH | 50 |
| Morphine | MOR | Morphine | 2000 |
| Phencyclidine | PCP | Phencyclidine | 25 |
| Ecstasy | MDMA | 3,4-Methylenediioxy-MET | 500 |
For prescription use in central laboratories only. This assay provides 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, Amphetamine, Benzodiazepines, and MDMA (Ecstasy) in human urine.
The provided document describes the Polymed Therapeutics' Fastep™ Dipstick and Dipcard Drugs of Abuse Screen Devices. Here's an analysis of the acceptance criteria and study proving its performance:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against its ability to detect specific drugs of abuse in human urine at defined cutoff concentrations. The performance is assessed by comparing its results to confirmed analytical methods (GC/MS and/or LC/MS) and a predicate device. While explicit "acceptance criteria" are not numerically stated in the provided text (e.g., "sensitivity must be >95%"), the reported performance indicates that it demonstrated "substantial equivalence" to the established confirmatory methods and predicate devices for all specified drugs. This "substantial equivalence" effectively serves as the acceptance criterion in the context of a 510(k) submission.
| Analyte | Abbreviation | Cutoff (ng/ml) | Reported Device Performance (vs. GC/MS, LC/MS and Predicate) |
|---|---|---|---|
| Amphetamine | AMP | 1000 | Substantial equivalence demonstrated |
| Benzodiazepines | BZO | 300 | Substantial equivalence demonstrated |
| Cocaine | COC | 300 | Substantial equivalence demonstrated |
| Marijuana | THC | 50 | Substantial equivalence demonstrated |
| Morphine | MOR | 2000 | Substantial equivalence demonstrated |
| Phencyclidine | PCP | 25 | Substantial equivalence demonstrated |
| Ecstasy | MDMA | 500 | Substantial equivalence demonstrated |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "blind-labeled clinical specimen correlation study" and "blind-labeled spiked control studies." However, specific sample sizes for these test sets are not provided in the given text.
The data provenance is not explicitly stated. The term "clinical specimen" suggests human-derived samples, but their geographic origin (country) and whether they are retrospective or prospective are not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established by Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are analytical laboratory methods, not human expert evaluations for establishing ground truth in this context. Therefore, no human experts were used in this specific manner for ground truth establishment.
4. Adjudication Method for the Test Set
Since the ground truth was established by instrumental analytical methods (GC/MS/LC/MS), there was no adjudication method involving human experts for the test set. The analytical results from GC/MS/LC/MS are considered definitive.
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
There is no mention of an MRMC comparative effectiveness study in the document. This device is a rapid chromatographic immunoassay, not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This device is an immunoassay that provides a qualitative result. It is inherently a "standalone" device in that its performance is judged on its own ability to detect the drugs without human-in-the-loop interpretation beyond reading the visual result (which is a standard part of such tests). The studies described ("clinical specimen correlation study" and "spiked control studies") evaluate the performance of the device itself.
7. The Type of Ground Truth Used
The type of ground truth used was confirmed analytical results from Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS). These are objective, gold- standard laboratory methods for drug detection and quantification.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. Immunoassays like this are typically developed and validated using a series of experiments (which could be considered part of a broader development/training phase), but the specific terminology of "training set" as used in machine learning is not applicable here. The presented studies seem to focus on the validation/test phase of the device.
9. How the Ground Truth for the Training Set was Established
As no explicit "training set" is mentioned in the machine learning sense, the method for establishing its ground truth is also not described. If we consider the broader development process, the ground truth for establishing the performance characteristics of the assay (e.g., setting cutoffs, ensuring specificity) would also rely on confirmed analytical methods like GC/MS and LC/MS.
§ 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).