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The On-Call™ Multi-Drug Home Test Cup is a screening test for the rapid detection of drugs in urine at a designated cut-off concentration of 50 ng/mL for Marijuana, 300 ng/mL for Cocaine, 1,000 ng/mL for Amphetamine, 1,000 ng/mL for Methamphetamine, 500 ng/mL for Ecstasy, 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 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™ Multi-Drug Home Test Cup is a rapid lateral flow immunoassay for the qualitative detection of drugs in urine at a 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, 500 ng/mL for Ecstasy, 2,000 ng/mL for Opiates, and 25 ng/mL for Phencyclidine. This test is used to provide only a preliminary analytical result. All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis. They are intended for the over-the-counter lay person use.

The On-Call™ Multi-Drug Home Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative screening of Marijuana, Cocaine, Amphetamine, Methamphetamine, Ecstasy, 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 drugs, 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, 500 ng/ml for Ecstasy, 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 colored-lines in the designated test region, while A urine specimen or a urine specimen containing Marijuana, Cocaine, Amphetamine, a megative anne specimen or a anno epididine at the concentration below the cutoff level will generate colored-lines in the test region. To serve as a procedural control, a colored-line whit generate control miss in antol region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

The provided text does not contain acceptance criteria for the device, nor does it detail a study performed to prove the device meets specific acceptance criteria in the way described in the request.

Instead, the document is a 510(k) summary for a drug test cup. It focuses on demonstrating substantial equivalence to a previously cleared predicate device (ACON Spectrum Multi-Drug Multi-Line Drug Screen Test, K031759) and establishing the device's technical characteristics and intended use.

Here's an breakdown of why the requested information cannot be extracted from the provided text:

• No explicit acceptance criteria table: The document does not list specific sensitivity, specificity, accuracy, or other performance metrics as acceptance criteria.
• No detailed study report: The document states that the new device (On-Call™ Multi-Drug Home Test Cup) is "identical to the ACON Key Cup (K031759) that is legally marketed for professional use." It then argues that "there is no issue regarding the safety or effectiveness of the product to perform its intended function" because of this similarity and the device's simple operation. This is a declaration of equivalence rather than a report of a new study proving performance against defined criteria.
• Focus on Substantial Equivalence: The FDA's letter confirms substantial equivalence to a predicate device, which is a regulatory pathway, not a detailed performance study.

Therefore, many parts of the requested table and information points cannot be filled based on the provided document.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance
As stated, the document does not contain explicit acceptance criteria or a dedicated performance study for the On-Call™ Multi-Drug Home Test Cup. The performance is implied to be equivalent to the predicate device due to identicality.

2. Sample size 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 relies on the equivalence to a previously cleared device rather than presenting new test set data.
• Data provenance: Not specified.

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 applicable as no new test set and associated ground truth establishment process is described.

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

• Not applicable as no new test set is described.

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 qualitative detection of drugs, not an AI-assisted diagnostic tool requiring human reader studies.

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

• The device is a standalone test in that it provides a result without an instrument or human interpretation for its primary detection, though confirmation by GC/MS is required for positive results. However, no "standalone performance study" in the context of an algorithm is presented.

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

• For the predicate device (K031759) and by implication for this equivalent device, the principle of ground truth for drug testing is typically established by definitive confirmatory methods like Gas Chromatography/Mass Spectrometry (GC/MS). The document explicitly states: "All positive test results obtained with these devices must be confirmed by another test method, preferably GC/MS analysis."

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. This is not an AI/machine learning device.

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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.

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.

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