(36 days)
A drug of abuse assay intended for use in clinical toxicology laboratories, physicians' offices, drug-of-abuse clinics and law enforcement agencies is an in-vitro diagnostic test for the qualitative identification of tetrahydrocannabinoid, in urine. Measurements that are obtained by this device are used in the diagnosis and treatment of marijuana use or overdose.
The QuickScreenTM One Step THC Screening Test utilizes colloidal gold as the label like other commercially available immunoassays for drug of abuse test kits, to qualitatively measure for the presence of THC by visual color sandwich one step immunoassay technology.
Here's an analysis of the provided text regarding the QuickScreen™ One Step THC Screening Test, structured according to your requested points:
Acceptance Criteria and Device Performance Study
The information provided describes a qualitative immunoassay for the detection of Tetrahydrocannabinoid (THC) in urine. The primary study presented is a clinical sample correlation study used to demonstrate substantial equivalence to existing devices.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly state pre-defined "acceptance criteria" in numerical terms (e.g., "Sensitivity must be >95%"). Instead, it reports the performance values achieved and concludes that these demonstrate "substantial equivalence" to other commercially available tests. The acceptance is implied by meeting or exceeding the performance characteristics of predicate devices.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | >98% (compared to Syva EMIT II) | >98% |
| Specificity | >98% (compared to Syva EMIT II) | >98% |
| Accuracy | >99% (compared to Syva EMIT II) | >99% |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. It mentions "clinical sample correlation study" and "two independent clinical laboratories," but the number of samples or cases used in these studies is not provided.
- Data Provenance: The data is from "clinical specimens." The country of origin is not explicitly stated, but the manufacturer (Phamatech) is in San Diego, California, USA, and the predicate device (Syva EMIT II) is from San Jose, CA. It is highly probable the data is from the USA. The study appears to be retrospective, using existing clinical specimens, although this is not explicitly confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable in the traditional sense of human readers interpreting images. The ground truth was established by comparison to a predicate device, the Syva EMIT II.
- Qualifications of Experts: The "experts" are the Syva EMIT II device itself, which is a "commercially available immunoassay." The document states that "Two independent clinical laboratories conducted studies which demonstrated the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians," implying general laboratory expertise, but not specific individual experts for ground truth establishment.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This is a comparison of a new device's output against a reference device's output, not a human consensus or adjudication of interpretations. The "correlation studies" are a direct comparison of results between the QuickScreen™ test and the Syva EMIT II.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a standalone in-vitro diagnostic test, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, a standalone performance study was done. The QuickScreen™ One Step THC Screening Test is an "in-vitro diagnostic test for the qualitative identification of Tetrahydrocannabinoid... in urine." Its performance characteristics (sensitivity, specificity, accuracy) were evaluated by comparing its results directly against those of the Syva EMIT II. The "studies which demonstrated the Phamatech QuickScreen™ exhibited excellent performance in the hands of professional laboratory technicians" refers to the operational use of the device itself, not human-in-the-loop interpretation improvement.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by a predicate device/reference method, specifically the Syva EMIT II. The EMIT II is an established immunoassay for THC detection.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. This document describes the performance evaluation of a device, not the development or training of an algorithm that would require a separate training set. Immunoassays are generally developed through biochemical and analytical optimization, not statistical training on labeled datasets in the same way machine learning models are.
9. How the Ground Truth for the Training Set was Established
- Ground Truth Establishment: Not applicable, as there is no mention of a "training set" in the context of this device's development as described. The device operates on established immunochemical principles.
§ 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).