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

est Multi-Drug Rapid 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. 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 crugs. 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 Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secodiazepines, Cocaine, 2- ethylidene-1.5dimethyl-3,3- diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana, Tramadol, Propoxyphene Fentanyl and 6-monoacetylmorphine in human urine at the cutoff concentrations of:

AllTest Multi-Drug 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 Rapid Test Cup and AllTest Multi-Drug 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 and no longer requires assembly before use.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

Device Name: AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Test Cup

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally established by the performance characteristics demonstrated in the studies, particularly the agreement/precision at and around the cutoff concentrations, and the specificity. Since this is an in vitro diagnostic (IVD) device, the "performance" here refers to its accuracy in detecting the target analytes and its overall reliability in a diagnostic context. This is fundamentally about how well the device matches a known, established ground truth.

• Agreement at -100%, -75%, -50% Cutoff: Generally 100% negative agreement.
• Agreement at +50%, +75% Cutoff: Generally 100% positive agreement.
• Agreement at -25% and +25% Cutoff: Ranged from 85.0% to 95.0% negative/positive agreement, respectively, demonstrating expected variability around the cutoff.
  All participants found the instructions easy to understand and follow (Flesch-Kincaid Grade Level 7). |

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

• Precision/Reproducibility Study:

  • Sample Size: For each drug and each concentration (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff), tests were performed in 2 runs per day for 25 days, using 3 lots of test cups. This means for each concentration and drug, there were 50 tests per lot (2 runs/day * 25 days) and 150 tests across 3 lots.
  • Data Provenance: Urine samples spiked with target drugs into drug-free urine. The drug concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study, not from actual patients.

• Analytical Specificity/Interference Study:

  • Sample Size: Not explicitly stated as a total number, but drugs and interfering compounds were spiked into drug-free urine samples and tested using 3 lots of devices for each interference condition.
  • Data Provenance: Laboratory prepared urine samples (drug-free urine spiked with various compounds).

• Method Comparison Study:

  • Sample Size: 80 unaltered urine clinical samples (40 negative and 40 positive) for each drug.
  • Data Provenance: Unaltered clinical urine samples. The country of origin is not specified but it is an in-house study.

• Lay Person Study:

  • Sample Size: 280 lay persons.
  • Data Provenance: Urine samples prepared by spiking drug(s) into drug-free pooled urine specimens. The concentrations were confirmed by LC-MS/MS. This is an analytical/laboratory-controlled study designed to evaluate user comprehension and ease of use, not true clinical performance with patient samples.

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

• Precision/Reproducibility, Analytical Specificity/Interference, Lay Person Study: Ground truth was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and standardized analytical method for drug concentration determination. No human experts were explicitly stated to establish this ground truth, as it's an objective chemical analysis.

• Method Comparison Study: Ground truth was established by LC-MS/MS. Similar to the above, this is an objective analytical method.

4. Adjudication Method for the Test Set

• For the Method Comparison Study, the device results were compared directly to the LC-MS/MS results. There is no mention of an adjudication process (e.g., 2+1, 3+1 expert review) for the ground truth itself, as LC-MS/MS is considered the definitive truth.
• For the Lay Person Study, the "ground truth" for the expected positive/negative call was based on the known spiked concentrations confirmed by LC-MS/MS. The participants' interpretations of the device results were then compared to this established truth. There was no adjudication of the lay person's reading, but rather an assessment of their accuracy against the known sample content.

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

• No, an MRMC comparative effectiveness study was not done.
• This device is a qualitative lateral flow immunochromatographic assay ("rapid test cup") for in vitro diagnostic use, intended for direct reading by a user (either professionals or lay persons). It does not involve AI or human readers interpreting complex images or data assisted by AI.
• The closest analogy is the "Lay Person Study," which assesses how well lay users can interpret the results without assistance on complex outputs, but there is no AI component.

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

• Yes, in spirit, the analytical performance studies (precision, specificity, stability) and the LC-MS/MS ground truth in the method comparison study represent "standalone" performance. The device itself (the immunochromatographic strip) is the "algorithm," and its chemical reactions are assessed according to established scientific principles, independent of human interpretation prior to result line formation.
• However, the final reading of the lines on the rapid test cup is still a human-in-the-loop step, even for laboratory personnel in the precision and method comparison studies, and especially for lay users in their study. The intent of these "rapid test" types of devices is precisely for direct human interpretation.

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

• The primary ground truth used across all analytical and method comparison studies was LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and quantitative laboratory method used for definitive drug detection and concentration measurement.

8. The Sample Size for the Training Set

• This submission describes a premarket notification (510(k)) for an in vitro diagnostic device. Unlike AI/ML devices, these types of products typically do not involve "training sets" in the machine learning sense.
• The manufacturing process, antibody selection, and assay design for these immunochromatographic tests are developed and refined through internal R&D, often using a range of samples and iterations. The document does not describe a formal 'training set' analogous to those used for AI algorithms. The data presented are for validation and verification of the finished device.

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

• As noted above, a "training set" in the AI/ML context is not applicable here. The development of the reagents and test design would have relied on standard laboratory practices for developing highly specific and sensitive immunoassays, with positive and negative controls and calibration against known concentrations, usually verified by gold-standard analytical methods like LC-MS/MS.

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AllTest Multi-Drug Rapid Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5-dimethy-3.3-diphenylpvrrolidine. Methylenedioxymethamphetamine. Morphine. Methadone. Oxycodone. Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Cup offers 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 Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone 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 must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Benzodiazepines, Cocaine, 2- ethylidene-1,5dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Panel offers 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 Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone 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 must be used. GC/MS or LC/MS is the recommended confirmatory method.

AllTest Multi-Drug Rapid Test Cup Rx tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1.5-dimethyl-3.3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone. Oxycodone, Phencycligine and Mariiuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Cup Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may yield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone 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 Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Benzodiazepines, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Test Panel Rx offers any combinations of the above listed analytes. It is for in vitro diagnostic use only. It is intended for prescription use.

The tests may vield positive results for the prescription drugs Buprenorphine, Benzodiazepines, Secobarbital, and Oxycodone 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.

The AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel are immunochromatographic assays that use a lateral flow system for the qualitative detection of target drug or drug metabolites in human urine. The products are single-use in vitro diagnostic devices. The AllTest Multi-Drug Rapid Test kit contains a Cup or a Panel device, a package insert. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the acceptance criteria and the studies conducted for the AllTest Multi-Drug Rapid Test Cup and AllTest Multi-Drug Rapid Test Panel for the detection of various drugs in human urine. The submission primarily focuses on the three new analytes: Amphetamine 1000, Cocaine 300, and Methamphetamine 1000, while referencing a previous submission (K182738) for other analytes.

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests typically revolve around the ability to correctly identify samples above and below the specified cut-off concentrations. The precision study results implicitly serve as the performance criteria, showing the percentage of correct identifications at various concentrations relative to the cut-off.

Acceptance Criterion: The device should consistently provide correct positive results for samples at or above the cut-off concentration and correct negative results for samples significantly below the cut-off concentration. For samples near the cut-off, a certain degree of variability is expected but needs to be within acceptable ranges (e.g., majority of results correctly identified).

Reported Device Performance (from Precision Studies - 3 lots, 25 replicates each, total 75 tests per concentration level):

Lay User Study Performance (Cup & Panel combined, n=20 per concentration level per drug):

(Note: The table only includes performance for the new analytes (AMP 1000, COC 300, MET 1000) for precision, and for all listed analytes in the lay user study, which implicitly includes the other cut-off values for AMP, COC, and MET, as well as the other drugs reported in K182738.)

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

Precision Studies (Laboratory Testing):

• Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 9 concentration levels were tested. For each concentration, 5 replicates were performed per day for 5 days, across 3 lots.
  • This equates to: 9 concentrations * 5 replicates/day * 5 days * 3 lots = 675 total tests per analyte for the precision study using spiked urine samples.
• Data Provenance: The document states, "These samples were prepared by spiking drug in negative urine samples." This indicates the data is from prospective, laboratory-controlled experiments using spiked urine samples. The country of origin for the samples themselves is not explicitly stated beyond being "negative urine samples," but the submitting company is Hangzhou Alltest Biotech Co.,Ltd. in China, suggesting the studies likely occurred there or with materials sourced globally.

Comparison Studies (Clinical Samples):

• Sample Size: For each of the three new analytes (Amphetamine 1000, Cocaine 300, Methamphetamine 1000), 80 unaltered clinical urine samples were used (40 negative and 40 positive).
  • This totals 80 samples per analyte (Cup and Panel results are reported on the same sample set).
• Data Provenance: The document states, "unaltered clinical samples." This suggests these were retrospective clinical samples. The country of origin is not specified.

Lay User Study:

• Sample Size: 560 lay persons participated. Urine samples were prepared at 7 concentration levels (negative, +/-25%, +/-50%, +/-75%, +100% of cut-off) for each drug. Each participant was provided with 1 blind labeled sample and a device.
  • For each of the approximately 14 drugs/cut-off concentrations evaluated, there were 7 concentration levels. Each concentration level had 20 tests (Agreement (%) is based on 20 total for each row). So, at minimum, 14 drugs * 7 concentrations * 20 tests/concentration = 1960 total tests were performed by lay users, distributed across the 560 participants.
• Data Provenance: The samples were "prepared by spiking drugs into drug free-pooled urine specimens," indicating prospective, laboratory-controlled experiments using spiked urine samples. The study was performed at "three intended user sites" but the country/region is not specified.

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

Precision Studies and Lay User Studies:

• Ground Truth Establishment: The ground truth for these studies was established by spiking known concentrations of drugs into negative urine samples and confirming them by LC/MS. This is a chemical/analytical method, not expert opinion.
• Number of Experts & Qualifications: Not applicable, as the ground truth was determined analytically.

Comparison Studies (Clinical Samples):

• Ground Truth Establishment: The ground truth for the clinical samples was established using LC/MS (Liquid Chromatography-Mass Spectrometry), which is the recommended confirmatory method as stated in the Indications for Use.
• Number of Experts & Qualifications: Not applicable, as the ground truth was determined via a definitive analytical method, not human expert consensus. "Three laboratory assistants" ran the device tests, but they were not establishing the ground truth.

4. Adjudication Method for the Test Set

Precision Studies and Lay User Studies:

• Adjudication Method: Not applicable. The ground truth was based on known spiked concentrations confirmed by LC/MS. The device's result was compared directly to this analytical ground truth.

Comparison Studies (Clinical Samples):

• Adjudication Method: Not explicitly described in terms of human adjudication. However, the document states: "The samples were blind labeled and compared to LC/MS results." This implies a direct comparison against a definitive analytical method (LC/MS) for ground truth, rather than an adjudication process involving multiple human interpretations of the ground truth. The "Discordant Results" tables show discrepancies between the viewer (device interpreter) results and the LC/MS result, indicating the LC/MS was the adjudicating method.

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

• No, a typical MRMC comparative effectiveness study was not explicitly described in the context of human readers improving with AI vs. without AI assistance.
• The document describes a "Comparison Studies" section, but this compares the device's performance to LC/MS results. It also mentions three "Viewer" (likely laboratory assistants or technicians) evaluating the device results against LC/MS, but it's not a study about human readers improving with AI assistance. It's a study of the device's performance when interpreted by human users against a gold standard.
• The device itself is a rapid test cup/panel, not an AI software.

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

• Not applicable. The device is an immunochromatographic assay (a physical test strip/cup), not an algorithm or AI software. Its performance inherently involves human-in-the-loop for result interpretation (reading the lines). The "Precision" study and the "Comparison Studies" evaluate the device's standalone analytical performance, but its practical use and reported performance include human interpretation of its visual output. The "Lay User Study" specifically evaluates performance with human-in-the-loop (lay users interpreting the results).

7. The Type of Ground Truth Used

• Precision Studies & Lay User Studies: The ground truth was established by spiking known concentrations of drugs into drug-free urine samples, with these concentrations confirmed by LC/MS. This is an analytically derived ground truth.
• Comparison Studies (Clinical Samples): The ground truth was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is considered a definitive analytical gold standard for drug detection.

8. The Sample Size for the Training Set

The document does not describe the development of an algorithm or AI model that would require a "training set." This device is a rapid diagnostic test based on immunochromatography. Therefore, the concept of a training set as used in machine learning is not applicable here.

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

As noted above, there is no mention of a training set for an algorithm or AI model. The device operates on chemical and immunological principles, not machine learning.

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