(262 days)
LumiQuick's QuickProfile Single Drugs of Abuse and QuickProfile Multi-Drugs of Abuse Screen Devices are rapid chromatographic immunoassays for the qualitative and simultaneous detection of one to nine of the following drugs in a variety of combinations in human urine. Both devices are available in test strip, dip panel, cassette panel and cup formats. The designed cutoff concentrations and direct calibrator for these drugs are as follows:
| AMP | Amphetamine | 1000 ng/ml |
|---|---|---|
| BAR | Secobarbital | 300 ng/ml |
| BZO | Oxazepam | 300 ng/ml |
| COC | Benzoylecgonine | 300 ng/ml |
| MTD | Methadone | 300 ng/ml |
| MAMP | Methamphetamine | 1000 ng/ml |
| OPI | Morphine | 300 ng/ml |
| PCP | Phencyclidine | 25 ng/ml |
| THC | THC 11-nor-Δ⁹-THC-9-COOH | 50 ng/ml |
These devices are intended for prescription use only. These assays provide 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 Amphetamine, Barbiturates, Benzodiazepines, Cocaine, Methadone, Methamphetamine. Opiates, Phencyclidine, and Marijuana in human urine.
Here's a summary of the acceptance criteria and study details for the QuickProfile™ Single Drug of Abuse Screen Device and QuickProfile™ Multi-Drugs of Abuse Screen Device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
| Drug/Analyte | Cutoff Concentration (ng/ml) | Reported Device Performance (Accuracy vs. GC/MS) |
|---|---|---|
| Amphetamine (AMP) | 1000 | 100% Accuracy |
| Secobarbital (BAR) | 300 | 100% Accuracy |
| Oxazepam (BZO) | 300 | 100% Accuracy |
| Benzoylecgonine (COC) | 300 | 100% Accuracy |
| Methadone (MTD) | 300 | 100% Accuracy |
| Methamphetamine (MAMP) | 1000 | 100% Accuracy |
| Morphine (OPI) | 300 | 100% Accuracy |
| Phencyclidine (PCP) | 25 | 100% Accuracy |
| THC 11-nor-Δ⁹-THC-9-COOH (THC) | 50 | 100% Accuracy |
Note: The reported device performance is "100% accuracy" for all drugs based on comparison with GC/MS confirmation level, as stated in the document.
Study Details
-
Sample size used for the test set and the data provenance:
- Sample Size: A minimum of 87 urine specimens were evaluated per drug.
- Data Provenance: The document does not explicitly state the country of origin. The test set consisted of "unaltered urine specimens" used in a clinical study. The study was performed by "lab professionals," suggesting a laboratory setting rather than field collection. It's not explicitly stated if the data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth was established by Gas Chromatography / Mass Spectrometry (GC/MS) confirmed drug concentration. GC/MS is a highly accurate analytical method, and its results are considered the "gold standard" for drug confirmation. Therefore, human experts were not directly establishing the ground truth in the same way they would for image interpretation. The "experts" in this context would be the "lab professionals" who operated the GC/MS equipment and interpreted its readouts, implying standard laboratory qualifications for such analytical tasks.
-
Adjudication method for the test set:
- Not applicable in the traditional sense for human-reviewed data. The ground truth was based on objective analytical results from GC/MS. There was no mention of multiple reviewers for the GC/MS results or an adjudication process for discrepancies.
-
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. This device is an immunoassay for drug detection in urine, not an AI-assisted diagnostic tool interpreted by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in a sense. The "accuracy and comparison study" evaluated the QuickProfile™ devices (the "algorithm only" in this context, albeit a chemical immunoassay rather than a software algorithm) directly against GC/MS confirmation. The devices themselves provide a visual result (presence or absence of a color band), which is then interpreted by a professional. The study demonstrates the standalone performance of the device in accurately detecting drugs compared to the gold standard.
-
The type of ground truth used:
- Analytical confirmation by Gas Chromatography / Mass Spectrometry (GC/MS). This is a highly accurate and widely accepted method for confirming the presence and concentration of drugs/metabolites in biological samples.
-
The sample size for the training set:
- The document does not explicitly mention a "training set" in the context of machine learning or AI. For immunoassay devices like this, the "training" equivalent would be the development and optimization of the assay's chemical components and cutoff levels. The document primarily focuses on the validation of the finalized device.
-
How the ground truth for the training set was established:
- As there is no explicit "training set" in the AI/ML sense, this question is not directly applicable. The development of the device would involve calibrating it to specific cutoff concentrations (e.g., 1000 ng/ml for AMP), and these cutoff concentrations themselves serve as the basis for determining positive or negative results. The method for establishing these cutoffs is not detailed but would typically involve analytical methods and clinical considerations during the assay development process, prior to the performance studies.
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).