(60 days)
The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a screening test for the rapid detection of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in urine at a designated cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. The test is intended for over-the-counter (OTC) consumer use.
This assay provides only a preliminary analytical test result. A more specific alternate analytical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is 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.
The On Call™ Multi-Drug Home Test for Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, and Phencyclidine in a urine sample. The test is based on the principle of antigen-antibody immunochemistry. It utilizes the mouse monoclonal antibody to selectively detect elevated levels of Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, Phencyclidine, and their metabolites in urine at a cutoff concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Methamphetamine, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test can be performed without the use of an instrument.
A drug-positive urine specimen will not generate a colored-line in the designated test region, while a negative urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine, Methamphetamine, Opiates, or Phencyclidine at the concentration below the cutoff level will generate a colored-line in the test region. To serve as a procedural control, a colored-line should generate a control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.
Here's an analysis of the provided text regarding the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific acceptance criteria in terms of sensitivity, specificity, or accuracy percentages. Instead, it relies on substantial equivalence to a previously cleared device (K020313) and other commercially available home drug tests.
The reported device performance heavily leans on the assertion that its identity and labeling are substantially equivalent to marketed devices, implying that their established performance is sufficient.
| Analyte | Cutoff Concentration (ng/mL) | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Marijuana | 50 | Substantially equivalent to previously cleared devices (K020313) and other commercial home tests in terms of safety and effectiveness for screening. | "identical to the ACON One Step Multi-Drug Multi-Line Screen Test Card/Device that is legally marketed under K020313 for professional use" and "substantially equivalent to a variety of rapid screening tests currently in commercial distribution, including the First Check® Home Drug Test and the Phamatech At Home™ Drug Test." |
| Cocaine | 300 | Same as above. | Same as above. |
| Amphetamine | 1,000 | Same as above. | Same as above. |
| Methamphetamine | 1,000 | Same as above. | Same as above. |
| Opiates | 2,000 | Same as above. | Same as above. |
| Phencyclidine | 25 | Same as above. | Same as above. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The claim of safety and effectiveness is based on the device being "identical" to an existing professional-use device and "substantially equivalent" to other commercially available home tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish ground truth for a test set. The justification for safety and effectiveness is based on the substantial equivalence to existing devices and the lack of reported issues with instruction following or result interpretation for those devices.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method as no specific test set or expert evaluation is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not report on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no mention of human readers or the effect size of AI assistance. The device is a self-administered home test.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device itself is a "rapid chromatographic immunoassay" that can be "performed without the use of an instrument" and is intended for "over-the-counter lay person use." This means its performance is inherently standalone in terms of automated output from the chemical reaction, without human interpretation beyond reading the lines. However, the document does not present a standalone performance study with quantifiable metrics like sensitivity or specificity. Its "standalone" performance is established by the assertion of substantial equivalence to other devices.
7. Type of Ground Truth Used
The primary ground truth relied upon for this submission is GC/MS analysis, which is stated as the "preferred confirmatory method" for any positive test results. However, this is for confirmation of preliminary results, not for establishing the ground truth of the device's initial screening performance in a study presented. For the purpose of this 510(k) submission, the "ground truth" for the device's performance claims is essentially the established performance and safety record of the predicate device (K020313) and other commercially available home drug tests.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is because the device is an immunoassay, not a machine learning algorithm that requires training data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
As there is no training set in the context of an immunoassay, this information is not applicable and not provided in the document.
§ 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).