(161 days)
For use in the qualitative analysis of cannabinoids in human urine at a cutoff concentration of 50 ng/mL.
FRONTLINE® CANNABIS is a homogeneous immunochromatographic assay for use in the qualitative analysis of cannabinoids in human urine. The assay is based on Gold Labeled Optical-read Rapid Immuno Assay (GLORIA) technology. Each test strip contains monoclonal antibodies reactive to a 11-nor-Δ9-THC-carboxylic acid derivative labeled with colloidal gold (conjugate) and 11-nor-Δ9-THC-carboxylic acid polyhapten, bulking agents, stabilizers and preservatives (solid phase). When immersed in urine, the test strip absorbs the volume of fluid necessary for the chromatographic reaction to occur. By capillary action, the urine passes through a compartment containing soluble conjugate which specifically binds to the cannabinoid analyte. Excess conjugate is retained by the solid phase in a separate compartment. Only that conjugate with bound cannabinoid analyte passes to the detection pad where a red-colored conjugate-analyte complex is viewed. The color developed on the detection pad is compared visually with a scale provided on the test strip vial. The intensity of the color developed correlates with the concentration of the analyte in the sample and the user may classify the analyte sample as: negative or positive (≥50 ng/mL).
Here's an analysis of the provided text regarding the FRONTLINE® CANNABIS device, structured according to your requested information categories:
Acceptance Criteria and Device Performance Study
The acceptance criteria for the FRONTLINE® CANNABIS device are not explicitly stated as numerical thresholds (e.g., "sensitivity must be >X%"). Instead, the conclusion of the performance study ("FRONTLINE® CANNABIS is substantially equivalent to other commercially available cannabinoid test systems") implies that the device's performance, as measured against predicate devices and confirmation methods, met an implicit standard of equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
Given the lack of explicit numerical acceptance criteria, the table below reflects the reported performance without specific "acceptance criteria" columns. The "Performance Metric" and "Reported Device Performance" are derived from the comparison studies.
| Performance Metric (Implicit Acceptance Criteria: Substantial Equivalence) | Reported Device Performance (vs. EIA & Confirmation) | Reported Device Performance (vs. FPIA & Confirmation) |
|---|---|---|
| Agreement with Predicate Device (Positive Samples) | 243 samples FRONTLINE® positive | 153 samples FRONTLINE® positive |
| Agreement with Predicate Device (Negative Samples) | 500 samples FRONTLINE® negative | 240 samples FRONTLINE® negative |
| False Positives | 14 samples | 3 samples |
| False Negatives | Not explicitly stated (implied 0 for this comparison if 243 were true positives) | 2 samples |
| Unconfirmed Samples | 4 samples | 1 sample |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set):
- Comparison to EIA: 761 metabolized urine samples
- Comparison to FPIA: 399 metabolized urine samples
- Data Provenance: The document does not specify the country of origin for the samples. It states that the samples were "metabolized urine samples evaluated at three sites" (for EIA comparison) and "evaluated at two sites" (for FPIA comparison). The type of data is retrospective, as it refers to "metabolized urine samples" that were collected and then evaluated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document refers to "confirmation analysis" and compares the FRONTLINE® device to "EIA and the confirmation method" and "FPIA and the confirmation method." This implies that a more definitive, likely laboratory-based, method was used as the ground truth. However, the document does not specify the number of experts involved in establishing this ground truth, nor their qualifications. It mentions only "the confirmation method."
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set. The term "confirmation analysis" suggests that the results from the predicate device and the FRONTLINE® device were compared against a higher-standard confirmation method, which implicitly serves as the adjudicator of true positive/negative status. However, no details about how discrepancies were resolved or if human adjudicators were involved are provided.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focuses on the standalone performance of the device compared to predicate devices and a confirmation method, not on human readers' improvement with or without AI assistance. The FRONTLINE® CANNABIS device itself is a "non-instrumented assay" requiring visual comparison, but the study design is not an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The FRONTLINE® CANNABIS device is described as a "non-instrumented assay" where "The color developed on the detection pad is compared visually with a scale provided on the test strip vial." The performance data presented are for the device itself determining positivity or negativity, with this visual interpretation being part of the device's operational design. The comparison is between the device's output and established methods (EIA, FPIA, and confirmation), making it a standalone evaluation of the device.
7. The Type of Ground Truth Used
The ground truth used was a "confirmation method" alongside predicate devices (EIA and FPIA). While the exact nature of this "confirmation method" is not detailed, in urine drug testing, confirmation typically refers to more definitive analytical techniques like Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS), which are considered gold standards for identifying and quantifying substances.
8. The Sample Size for the Training Set
The document does not mention a training set or any machine learning/AI model training. This device appears to be an immunochromatographic assay, not an AI-driven one.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for this type of device, this question is not applicable.
§ 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).