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The On Call Home Drug Test for Marijuana is a screening test for the rapid detection of Marijuana (THC) and its metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC or its metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 Home Drug Test Marijuana & Cocaine is a screening test for the rapid detection of Marijuana (THC), Cocaine (COC) and their metabolites in urine at a designated cut-off concentration of 50 ng/mL for Marijuana (THC) and 300 ng/mL for Marijuana & Cocaine (THC, COC). The test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers with information concerning the presence of THC, COC or their metabolites in a urine sample. Information, along with the materials for shipping a portion of the urine specimen to the laboratory for confirmation testing of a preliminary positive result, the second step in the process, is provided.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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 Home Drug Tests for Marijuana (THC), or Marijuana & Cocaine (THC, COC) are competitive binding, lateral flow immunochromatographic assays for the qualitative screening of Marijuana, or Marijuana and Cocaine 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 drugs and their metabolites in urine at a cutoff concentration of 50 ng/mL for Marijuana (THC) and 300 ng/mL for Cocaine (COC). These tests 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, or Marijuana and Cocaine 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 always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text does not contain specific acceptance criteria or a dedicated study demonstrating that the "On Call Home Drug Test for Marijuana" or "On Call Home Drug Test for Marijuana & Cocaine" device meets predefined acceptance criteria.

Instead, the submission leverages the concept of substantial equivalence to legally marketed predicate devices. The core argument for safety and effectiveness is that the devices are "identical" to previously cleared devices (K040327 for OTC use, and K003557 and K020313 for professional use) and their labeling is similar to other commercially available rapid screening tests.

Therefore, for the information requested:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the submission. The submission does not present a table of acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) derived from a new study for these specific devices. The FDA's 510(k) clearance is based on substantial equivalence to predicate devices, implying that their performance is considered comparable to the established performance of those predicates.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

No new test set data is presented for these specific devices. The submission relies on the performance of the predicate devices. Therefore, this information is not applicable as no new study was conducted for these devices to generate a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This information is not applicable as no new study was conducted for these devices to generate a test set requiring expert ground truth establishment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable as no new study was conducted for these devices to generate a test set.

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:

This is not applicable. The device is an immunoassay for drug detection, not an AI-assisted diagnostic tool that would involve human "readers" or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. The device is a qualitative immunoassay, not an algorithm. Its performance is inherent to the chemical reactions and visual interpretation of lines, not a computational algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the predicate devices, it is highly probable that the ground truth for their performance studies would have been established through Gas Chromatography/Mass Spectrometry (GC/MS) analysis, as this is explicitly stated as the "preferred confirmatory method" for positive results from these rapid screening tests. However, the submission for the On Call Home Drug Test does not detail the ground truth methodology from the predicate studies.

8. The sample size for the training set:

This is not applicable. The device is a lateral flow immunoassay, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:

This is not applicable as there is no training set for this type of device.

In summary: The provided 510(k) summary for the On Call Home Drug Tests primarily relies on demonstrating substantial equivalence to pre-existing, legally marketed devices rather than presenting new performance data or studies against specific acceptance criteria for these particular devices. The core argument for safety and effectiveness is based on the established performance and user experience of its predicate devices.

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