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The First Check® Multi Drug Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP) is a screening test for the rapid detection of one to seven of the above listed drugs in a variety of combinations in human urine. The designated cut-off concentrations of these drugs are as follows: Marijuana at 50 ng/ml, Cocaine at 300 ng/ml, Amphetamine at 1000 ng/ml, Methamphetamine at 1000 ng/ml, Ecstasy at 500 ng/ml, Opiates at 2000 ng/ml, and Phencyclidine at 25 ng/ml.

This device 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 test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence or absence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing of the second step in the process, along with the materials for shipping the unne speciment o the laboratory, is provided.

The First Check® Multi Drue Cup 7 for Marijuana (THC), Cocaine (COC), Amphetamine (AMP), Methamphetamine (MET), Ecstasy (MDMA), Opiates (OPI) and Phencyclidine (PCP), like other commercially available drug screening tests, qualitatively detects the presence or absence of the above listed drugs and their metabolites in urine, using a one step. rapid chromatographic immunoassay which operates under the principle of recognition and formation of specific antibody/target drug complexes.
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 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. If a control line does not appear for any reason, the results are considered invalid and should not be interpreted. The sample should either be retested using a new First Check Multi Drug Cup 7 or the sample should be mailed in for confirmation.

The K051966 submission describes the "First Check® Multi Drug Cup 7" for rapid screening of several drugs of abuse in urine for over-the-counter (OTC) consumer use. The device's performance relies on its substantial equivalence to a predicate device (Ameditech ImmuTest Drug Screen Cup) that was previously cleared for professional use, and a consumer study demonstrating effective use by lay users.

Here's an breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state formal "acceptance criteria" for precision, accuracy, sensitivity, or specificity in a table format. However, it strongly implies that the device's performance is acceptable because it is identical to a legally marketed professional-use device (Ameditech ImmuTest Drug Screen Cup, K040092 and K042975) and a consumer study demonstrated excellent overall performance with lay users.

The performance is implicitly tied to:

• Qualitative detection: Presence or absence of drugs/metabolites.
• Cut-off concentrations: Specific thresholds for each drug (e.g., Marijuana at 50 ng/ml).
• Specific reactions: The analytical studies of the predicate device (Ameditech ImmuTest Drug Screen Cup) indicate that the drug test reacts specifically with the listed drugs and their metabolites.

2. Sample Size Used for the Test Set and Data Provenance

• Test set sample size: The text mentions a "consumer study" but does not specify the sample size used for this study.
• Data Provenance: The text does not explicitly state the country of origin. It relates to a US FDA 510(k) submission, suggesting it's relevant to the US market. The study appears to be prospective in nature, as it's a "consumer study using the First Check® Home Drug Test" to demonstrate its performance with lay users. This indicates data was collected specifically for this submission or related clearances.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• The document does not describe a traditional expert-adjudicated test set for performance metrics like sensitivity/specificity against a ground truth. Instead, it relies on two primary lines of evidence:
  • Analytical studies of the identical predicate device: These studies (from K040092 and K042975) would have established the analytical performance (specificity, cut-offs) in a laboratory setting. No details on experts for these specific studies are provided in this document.
  • Consumer study: This study focused on user comprehension and ability to perform the test, rather than establishing diagnostic ground truth of the urine samples themselves. No experts are mentioned in relation to this consumer study's ground truth for drug presence.

4. Adjudication Method for the Test Set

• Not applicable in the traditional sense for diagnostic performance. The consumer study likely assessed participant understanding and correct interpretation of results against a predefined correct outcome, but no multi-expert adjudication method is described. The analytical studies for the predicate device would have relied on laboratory standards and confirmatory methods, but adjudication methods are not detailed here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This device is a rapid, qualitative immunoassay, not a complex imaging or diagnostic interpretation system where MRMC studies are typically performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Yes, implicitly. The immunoassay itself performs the "algorithm" for detecting drugs. The analytical studies (mentioned regarding the predicate device K040092 and K042975) would represent the "standalone" performance of the test mechanics in a laboratory setting. The consumer study then assesses the human-in-the-loop (lay user) aspect.

7. The Type of Ground Truth Used

• For the analytical performance (inherent to the immunoassay): The ground truth would typically be established by controlled spiking of drug metabolites into urine samples at known concentrations and/or confirmatory laboratory methods like Gas Chromatography/Mass Spectrometry (GC/MS) for naturally occurring samples. The document states that the predicate's analytical studies indicate specific reactions and the instruction for the device advises "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method."
• For the consumer study (usability): The ground truth would be related to whether the lay users correctly followed instructions and interpreted the test lines (or lack thereof) as positive/negative according to known sample results (which would have been determined by analytical ground truth).

8. The Sample Size for the Training Set

• The document does not specify a separate "training set" as this is a chemical immunoassay device, not a machine learning algorithm that typically requires explicit training datasets. The device's underlying technology and performance characteristics would have been established through extensive R&D and analytical validation (e.g., cross-reactivity studies, precision studies) over time, which do not fit the common definition of a "training set" in AI/ML contexts.

9. How the Ground Truth for the Training Set Was Established

• As above, a "training set" in the AI/ML context is not applicable here. The device's design and manufacturing rely on established immunoassay principles, and its performance characteristics (specificity, accuracy against known concentrations) would have been validated through standard laboratory analytical methods using controlled samples (e.g., spiked urine samples, confirmed positive/negative clinical samples).

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