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AllTest Multi-Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Cup can be a single drug test cup or used for any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for OTC use.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepine, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Fentanyl, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Tramadol, Propoxyphene and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Cup can be a single drug test cup or used for any combination of the above listed analytes. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Urine Test Cup and AllTest Multi-Drug Rapid Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine.

The devices are a cup format. Each test device is sealed with sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format.

The provided document describes the analytical and user performance of the "AllTest Multi-Drug Rapid Urine Test Cup" and "AllTest Multi-Drug Urine Test Cup" for detecting various drugs in human urine.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific percentages for sensitivity, specificity, or agreement. However, the performance studies demonstrate that the device is designed to correctly identify drug presence/absence relative to a defined cutoff concentration. For qualitative drug tests, a common expectation is high agreement rates for samples significantly above or below the cutoff, with some variability allowed for samples near the cutoff.

The reported device performance can be summarized from the precision and lay person studies. The precision studies show ideal performance at concentrations far from the cutoff (100% agreement), and expected variability (around 50% positive/negative calls) at the cutoff concentration. The lay person study similarly shows very high agreement (typically 90-100%) for samples adequately far from the cutoff concentration.

Since no explicit quantitative acceptance criteria are given in the provided text, the reported performance is presented in relation to the ideal behavior of a qualitative assay around its cutoff.

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

• Precision/Reproducibility: For each drug and each concentration level (total 9 concentrations), 50 tests were performed per lot. With 3 lots, this amounts to 150 tests per concentration level per drug. The total number of precision tests for the 8 reported drugs (MOP 2000, EDDP, COC 300, TRA, PPX, AMP 1000, MET 1000, 6-MAM) and their 9 concentration levels is 8 * 9 * 50 * 3 = 10,800 tests.
  • Data Provenance: Samples were "spiked target drug in drug-free urine samples." The concentrations were confirmed by LC-MS/MS. This suggests internally prepared, controlled samples rather than real-world clinical samples, likely conducted within a laboratory setting. No country of origin is explicitly stated, but given the submitter "Hangzhou Alltest Biotech Co.,Ltd", it is likely from China, and the study was "carried out for samples." This is a retrospective analysis of prepared samples.
• Analytical Specificity/Interference: Samples were "spiked into drug-free urine" and tested using three lots of the device. The number of samples per compound is not explicitly stated, but results are given as the "Minimum concentration required to obtain a positive result," implying sufficient testing to determine this.
  • Data Provenance: Prepared in-house samples.
• Method Comparison Study: For each drug, 80 clinical urine samples (40 negative, 40 positive). For the 8 drugs reported, this is 8 * 80 = 640 clinical samples.
  • Data Provenance: "unaltered urine clinical samples." No country of origin is specified, but the study was "performed in-house." This is a retrospective analysis of acquired clinical samples.
• Lay Person Study: 280 lay persons participated. Each participant tested 7 samples for each drug (7 concentration levels per drug). The number of drug analyses per person or per drug is not explicitly stated in a single count. The results tables show that for each drug and each concentration, 20 tests were performed (e.g., for AMP 1000 at -100% cutoff, "Total" is 20).
  • Number of Participants: 280 lay persons.
  • Data Provenance: Samples were "prepared at the following concentrations; -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens." Concentrations confirmed by LC-MS/MS. This indicates internally prepared, controlled samples tested by lay users at "three intended user sites." No country of origin specified for the lay persons, but likely within the operational scope of the manufacturer/sponsor for this type of OTC product validation. This is a prospective study involving human subjects.

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

• Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: The ground truth for these studies was established by preparing samples with known concentrations of drugs using spiking into drug-free urine, and confirmed by LC-MS/MS. These are analytical methods and do not typically involve human experts for ground truth establishment.
• Method Comparison Study: The ground truth for the clinical samples was established using LC-MS/MS results. LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry) is a highly sensitive and specific analytical technique considered the gold standard for confirmatory drug testing. Therefore, human experts (e.g., laboratory professionals) in analytical chemistry and toxicology would have been involved in performing and interpreting these LC-MS/MS analyses, though their specific number or qualifications are not detailed in this document.

4. Adjudication Method for the Test Set

• Precision/Reproducibility & Analytical Specificity/Interference: Ground truth was based on known preparations and LC-MS/MS confirmation; therefore, no adjudication by human experts was required for these analytical performance studies.
• Method Comparison Study: The document states that "three operators" ran the test cups. Discrepancies between the test cup result and the LC-MS/MS result are listed as "Discordant" results. There is no explicit mention of an adjudication method for the test cup results, such as a 2+1 reading or a consensus reading. It appears the outcome recorded by each operator was directly compared to the LC-MS/MS ground truth.
• Lay Person Study: Participants were given a device and "the package insert." There's no mention of expert readers adjudicating the lay person's interpretation. The "Agreement (%)" is calculated based on the lay person's result compared to the known spiked concentration.

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

No, an MRMC comparative effectiveness study was not conducted in the way typically seen for AI-assisted diagnostic devices where human readers' performance with and without AI assistance is compared.

This device is an in vitro diagnostic (IVD) test cup, not an AI software. The "operators" in the method comparison study were executing the device, but the study was not designed to measure the effect size of human readers improving with AI vs. without AI assistance. Instead, it compared the device's performance (as interpreted by trained operators) against a gold standard (LC-MS/MS). The lay person study assessed the device's usability and accuracy when interpretation was done by untrained individuals following instructions, which is a key part of OTC device validation, but not an MRMC study for AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the analytical performance studies (Precision/Reproducibility, Linearity, Stability, Analytical Specificity/Interference) and the method comparison study can be considered standalone performance studies of the device itself, as evaluated by trained laboratory personnel or against analytical standards.

In the context of IVD devices like this test cup, the "algorithm" is the biochemical reaction and visual line interpretation on the strip. The precision, specificity, and comparison to LC-MS/MS results directly assess the analytical performance of the device without explicit "human-in-the-loop" decision-making, beyond reading the visual output. The "Lay Person study" then evaluates how effectively the intended user (human-in-the-loop) can interpret this standalone performance.

7. The Type of Ground Truth Used

The primary ground truth used for performance evaluation was:

• Known Spiked Concentrations: For precision, stability, analytical specificity, and the lay person study, urine samples were prepared by spiking known concentrations of target drugs into drug-free urine. These concentrations were confirmed by LC-MS/MS.
• LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): For the method comparison study of clinical samples, LC-MS/MS was used as the reference method (gold standard) to establish the true presence and concentration of drugs in the urine samples.

8. The Sample Size for the Training Set

This document describes a 510(k) premarket notification for a rapid drug test cup, which is an in vitro diagnostic device. These devices are typically developed based on established immunoassay principles and optimized through various analytical and clinical studies.

The concept of a "training set" is usually associated with machine learning or AI models. Since this device is a competitive binding, lateral flow immunochromatographic assay (a chemical/biological test, not an AI or software algorithm in the conventional sense), there is no explicit "training set" as understood in machine learning.

The development and optimization of the test components (antibodies, membrane, reagents, etc.) would involve extensive internal testing and iteration, but this is part of product development and not typically reported as a "training set" in regulatory submissions for IVDs.

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

As noted in point 8, the concept of a "training set" for this type of IVD device (lateral flow immunoassay) is not applicable in the same way it would be for an AI/ML device. Therefore, the question of how ground truth was established for a training set does not apply to this submission. The development process likely involved iterative testing with known drug concentrations and optimization of reagent formulations to achieve desired performance characteristics.

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