(153 days)
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine in urine to assist in screening of drugs of abuse. For in vitro Diagnostic Use.
The detection cutoff concentrations are as follows:
THC 11-nor-Δ9-THC-9-carboxylic acid 50 ng/ml
OPI Morphine 2000 ng/ml
COC Benzoylecgonine 300 ng/ml
MET D-Methamphetamine 1000 ng/ml
Immunoassay for the qualitative detection of THC metabolite, opiates, cocaine metabolite, methamphetamine in urine to assist in screening of drugs of abuse samples at home or work places. For in vitro Diagnostic Use.
The detection cutoff concentrations are as follows:
THC 11-nor-Δ⁹-THC-9-carboxylic acid 50 ng/ml
OPI Morphine 2000 ng/ml
COC Benzoylecgonine 300 ng/ml
MET D-Methamphetamine 1000 ng/ml
Status Stik™ THC/OPI/COC/MET is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, and methamphetamine.
LifeSign® Home Drug Test (THC/OPVCOC/MET) is simple one step immunochromatographic test for the rapid, qualitative, simultaneous detection of THC, opiates, cocaine, and methamphetamine.
The provided text describes two devices, "Status Stik™ THC/OPI/COC/MET" and "LifeSign® Home Drug Test (THC/OPI/COC/MET)", which appear to be very similar. The information about the study and acceptance criteria is primarily presented for the "LifeSign® Home Drug Test (THC/OPI/COC/MET)" in the "Consumer Study" section.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" as a target threshold. Instead, it reports the "overall accuracy" from a consumer study as the performance metric. The implied acceptance, given the "Conclusion: The device is substantially equivalent..." and "This letter will allow you to begin marketing your device..." is that this performance met the necessary regulatory thresholds.
| Drug Analyte | Cutoff Concentration | Reported Device Performance (Overall Accuracy) |
|---|---|---|
| THC | 50 ng/mL 11-nor-Δ⁹-THC-9-carboxylic acid | Over 95% |
| OPI | 2000 ng/mL morphine | Over 95% |
| COC | 300 ng/mL benzoylecgonine | Over 95% |
| MET | 1000 ng/mL d-methamphetamine | Over 95% |
Note: The reported "Over 95% overall accuracy" is a single figure for the entire device, not specific to each drug analyte individually. However, since the test is for simultaneous detection of all four, this accuracy likely pertains to combined performance or a weighted average.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for the "Consumer Study." The "Substantial Equivalence" section mentions that the previous predicate devices "demonstrated 100 % correlation when more than 90 specimens for each drug were compared respectively." This refers to predicate devices, not directly the consumer study for the new device.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is referred to as a "Consumer Study," implying prospective collection of data from lay users in a home setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no information provided about experts being used to establish ground truth for the "Consumer Study." The "Substantial Equivalence" section refers to comparisons with predicate devices, implying that the ground truth for those comparisons would have been laboratory methods, but not specifically indicating expert review for the consumer study of the new device.
4. Adjudication Method for the Test Set
No information is provided regarding an adjudication method for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable. The device described is an immunoassay for drug detection, not an AI-assisted diagnostic device requiring human reader interpretation in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is an immunoassay test, which functions as a standalone (algorithm only for chemical detection) without human-in-the-loop performance in the sense of AI analysis. The "Consumer Study" assesses its performance when used by lay users, essentially its standalone performance in their hands.
7. The Type of Ground Truth Used
The ground truth used for establishing the "Over 95% overall accuracy" in the "Consumer Study" is not explicitly defined in the provided text. However, for drug testing devices, the ground truth is typically established by laboratory-confirmed reference methods (e.g., GC/MS or HPLC) that independently confirm the presence and concentration of the drugs/metabolites in the urine samples. The 100% correlation with predicate devices mentioned earlier also implies comparison to such definitive methods as a form of ground truth for those comparisons.
8. The Sample Size for the Training Set
No training set information is provided for the "LifeSign® Home Drug Test (THC/OPI/COC/MET)." As an immunoassay, it is a chemical-based test and does not typically involve machine learning training sets in the same way an AI algorithm would. Its development would involve optimization and validation against known samples, but the term "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
As "training set" doesn't apply directly to this type of immunoassay, this question is not relevant. The performance verification would rely on well-characterized samples with known drug/metabolite concentrations, confirmed by reference laboratory methods.
§ 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).