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The Accu-Stat™ Home Drug Test for Marijuana (THC) is a screening test for the rapid detection of THC and its metabolites in human urine at a cut-off level of 50 ng/ml. 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 or absence 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.

The Accu-Stat™ Home Drug Tcst for Marijuana and Cocaine (THC, COC) is a screening test for the rapid detection of THC and/or COC and its metabolites in human urine at a cut-off level of 50 ng/ml for THC and 300 ng/ml for 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 or absence of either 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.

The Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC), like other commercially available drug screening tests, qualitatively measures the presence or absence of THC and COC and their metabolites in urine, using a one step, rapid chromatographic immunoassay which operates under the principle of competitive binding. Drugs, which may be present in the urine specimen, compete against the drug conjugate for binding sites on the antibody. During testing, a urine specimen migrates upward by capillary action. Marijuana, if present in the urine specimen below 50 ng/ml, and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites of the antibody coated particles in the test device. The antibody coated particles will then be captured by immobilized marijuana or cocaine conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the marijuana level is above 50 ng/ml because it will saturate all the binding sites of anti-marijuana antibodies. The same holds true for cocaine if the level is above 300 ng/ml. It will saturate all the binding sites of anti-cocaine antibodies and therefore the colored line will not form in the test region. A drug-positive urine specimen will not generate a colored line in the test line region because of drug competition, while a drug-negative urine specimen will generate a line in the test region because of the absence of a drug competition. To serve as a procedural control, a colored line will always appear at the control line region if the test has been performed properly.

The provided text describes two devices, the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC). It outlines their intended use and claims substantial equivalence to predicate devices, but does not include a detailed study with acceptance criteria and specific performance metrics for the Accu-Stat™ devices themselves.

Instead, the submission states that "The consumer studies using the Accu-Stat™ Home Drug Test for Marijuana (THC) and the Accu-Stat™ Home Drug Test for Marijuana & Cocaine (THC, COC) demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC."

It further argues for safety and effectiveness by claiming the devices are "identical to the ACON Laboratories One Step Marijuana Test Device and the Multi-Drug Multi-Line Device that is legally marketed under K003557 and K020313 respectively for professional use." This suggests reliance on the predicate devices' performance rather than a new, independent study with specific acceptance criteria reported in this document for the Accu-Stat™ devices.

Therefore, I cannot populate all the requested fields with specific, quantifiable data directly from this document regarding the Accu-Stat™ devices' performance against explicit acceptance criteria. The document claims substantial equivalence and mentions "consumer studies" but does not detail their methodology, results, or the acceptance criteria used.

Based on the provided text, here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated for the Accu-Stat™ devices in this document. The document refers to cut-off levels as part of the device's mechanism: "Marijuana, if present in the urine specimen below 50 ng/ml... and Cocaine, if present in the urine specimen below 300 ng/ml, will not saturate the binding sites..." This describes the functional threshold rather than an acceptance criterion for accuracy or precision.
• Reported Device Performance: The document offers a qualitative statement: "demonstrates that the test exhibits excellent overall performance in the hands of lay users. The data supports the conclusion that the consumer can use the Accu-Stat™ Home Drug Tests to obtain immediate, preliminary information regarding the possible use of THC and COC." No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are provided in this text for the Accu-Stat™ devices themselves.

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

• Sample Size: Not specified. The document mentions "consumer studies" but does not quantify the sample size.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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)

• Not specified. The document does not describe the establishment of a ground truth for a test set for these specific devices, only mentions that they are "screening tests" and preliminary, requiring confirmation testing.

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

• Not applicable as the details of a specific test set study for these devices (beyond "consumer studies") are not provided.

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

• Not applicable. This device is a rapid immunoassay for drug detection, not an AI-assisted diagnostic device, nor does the document describe a study of human readers.

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

• The device is a standalone immunoassay kit intended for "lay users" (consumers) at home without professional human-in-the-loop involvement for initial screening. However, the performance data for such standalone use (e.g., accuracy against a gold standard) is not detailed in this document. The instructions advise a second step of confirmation testing by a lab for positive results.

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

• Not specified for the "consumer studies." Given the nature of a drug test, a typical ground truth would be laboratory confirmation using a highly accurate method like GC/MS (Gas Chromatography/Mass Spectrometry). The document only states that the device is the "first step in a two-step process to provide over-the-counter (OTC) consumers... with information regarding the presence of THC or COC and their metabolites in a urine sample. Information regarding the second step, confirmation testing, is provided." This implies that the device offers a preliminary result rather than a definitive ground truth.

8. The sample size for the training set

• Not applicable. This device is an immunoassay, not a machine learning or AI-based system that would typically have a "training set."

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

• Not applicable for the same reason as above.

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