(48 days)
The Advantage Marijuana (THC) and Cocaine Home Drug Test is designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL and Cocaine metabolites at a cut off of 300ng/mL.
The test is the first part of a two-step process to provide consumers with information regarding the presence or absence, of THC and /or Cocaine in a urine sample. Confirmation, using GC/MS, of any possible drug result is recommended as the second step.
The Advantage Marijuana (THC) and Cocaine Home Drug Test is an immunochromatographic based one step in vitro test for use at home.
This 510(k) submission (K011962) describes the "Advantage Marijuana (THC) and Cocaine Home Drug Test." The information provided mainly focuses on the regulatory aspects and intended use of the device. Consequently, detailed clinical study data, including specific acceptance criteria and study design elements, are not fully elaborated in the provided text.
Based on the available information, here's an analysis:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary states the intended cut-off levels for both substances, which act as the functional acceptance criteria for the qualitative detection. However, it does not present a table of acceptance criteria or explicitly report device performance metrics like sensitivity, specificity, or accuracy against these criteria.
| Acceptance Criteria (Cut-off Level) | Reported Device Performance |
|---|---|
| Marijuana (THC): 50 ng/mL | Not explicitly reported in terms of standard performance metrics (e.g., sensitivity, specificity, accuracy) within the provided text. The device is "designed for the qualitative determination of THC (cannabinoids) in human urine at a cut off level of 50ng/mL." |
| Cocaine metabolites: 300 ng/mL | Not explicitly reported in terms of standard performance metrics (e.g., sensitivity, specificity, accuracy) within the provided text. The device is "designed for the qualitative determination of Cocaine metabolites at a cut off of 300ng/mL." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include any information about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The provided text does not include any information about the number of experts used to establish ground truth or their qualifications. Given that this is an in-vitro diagnostic device for home use, it's possible that the "ground truth" establishment might not involve "experts" in the clinical imaging sense, but rather laboratory analysis.
4. Adjudication Method for the Test Set
The provided text does not include any information about an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC study is typically performed for imaging or interpretation-based diagnostic devices where human readers are involved. This device is an immunochromatographic home drug test. Therefore, it is highly unlikely and not applicable for this type of device. The text does not mention any such study.
6. Standalone (Algorithm Only) Performance
This device is an immunochromatographic test, not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance does not apply. The device itself performs the detection.
7. Type of Ground Truth Used
The "ground truth" for this type of immunoassay is established by confirmatory laboratory testing, specifically GC/MS (Gas Chromatography/Mass Spectrometry). The 510(k) clearly states: "Confirmation, using GC/MS, of any possible drug result is recommended as the second step." This indicates that GC/MS would be the reference method for establishing the true presence or absence of the drugs and their metabolites at the specified cut-off levels.
8. Sample Size for the Training Set
The provided text does not include any information about the sample size for the training set. For an immunoassay, "training set" might refer to the samples used during assay development and optimization, rather than a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
The provided text does not explicitly state how the ground truth for any "training set" was established, but it is highly probable that it would also be through GC/MS (Gas Chromatography/Mass Spectrometry), similar to the confirmation method mentioned for user results. This is the gold standard for drug quantification in urine.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).