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AllTest Multi-Drug Urine Test Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Urine Test Panel can be a single drug test panel 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 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 Panel tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Nortriptyline, Marijuana and Fentanyl in human urine at the cutoff concentrations of:

AllTest Multi-Drug Rapid Urine Test Panel can be a single drug test panel 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 distinquish 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 Panel and AllTest Multi-Drug Rapid Urine Test Panel 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 panel 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.

The provided document describes the acceptance criteria and study that proves the device (AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel) meets the acceptance criteria.

Note: This device is a qualitative in-vitro diagnostic test, not an AI-based medical device. Therefore, questions related to AI-specific aspects (e.g., number of experts for ground truth, MRMC study, training set, effect size of AI assistance) are not applicable to this submission. The "study" described focuses on analytical performance, method comparison (against a gold standard chemical method), and a lay-person usability study.

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

The document defines performance in terms of precision (reproducibility) and method comparison with LC-MS/MS. The acceptance criteria for these qualitative tests are implicitly demonstrated by the reported agreement with LC-MS/MS results, particularly around the cutoff concentrations. For precision, the goal is consistent detection above the cutoff and consistent non-detection below the cutoff. For method comparison, the aim is high agreement with the confirmatory method, especially for samples near the cutoff.

Table of Performance (Based on "Precision/Reproducibility" and "Method Comparison Study" sections):

• Operator A: 1 sample (494.481 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (491.559 ng/mL, expected positive) was reported positive, 1 sample (619.861 ng/mL, expected negative) was reported negative. (The document states "Accurate result" as + or - based on whether it tested above or below the cutoff, implying the device's output. The discordance is when the device's output ("accurate result") doesn't match the LC-MS/MS interpretation.) |
  | BAR | 300 | At Cutoff (300 ng/mL): 21-23 negative / 27-29 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (375 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (225 ng/mL): 50 negative / 0 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (304.564 ng/mL, expected negative) was reported negative.
• Operator B: 1 sample (294.112 ng/mL, expected positive) was reported positive.
• Operator C: 1 sample (271.093 ng/mL, expected positive) was reported positive, 1 sample (304.564 ng/mL, expected negative) was reported negative. |
  | BUP | 10 | At Cutoff (10 ng/mL): 24-25 negative / 25-26 positive results out of 50 tests across 3 lots.
  At +25% Cutoff (12.5 ng/mL): 0-1 negative / 49-50 positive results.
  At -25% Cutoff (7.5 ng/mL): 49-50 negative / 0-1 positive results. | Overall: Good agreement.
  Examples:
• Operator A: 1 sample (11.971 ng/mL, expected negative) was reported negative, 1 sample (9.635 ng/mL, expected positive) was reported positive.
• Operator B: 1 sample (10.385 ng/mL, expected negative) was reported negative.
• Operator C: 1 sample (9.149 ng/mL, expected positive) was reported positive. |
  | ... | ... | (Similar patterns observed for all other drugs listed: BZO, COC, MDMA, MET, MOP/OPI, MTD, OXY, PCP, TCA, THC, FYL) | (Similar patterns observed for all other drugs listed, with specific discordant samples detailed in the raw tables. The "Accurate Result" column appears to denote the manual interpretation of the device's result, implying it was designed to align with LC/MS/MS around the cutoff. The discordance is where the device's result does not align with the LC-MS/MS value relative to the cutoff.) |

Key Acceptance Criteria (Implicit from Study Design):

• Precision/Reproducibility: The device should consistently return positive results for samples significantly above the cutoff concentration and consistently negative results for samples significantly below the cutoff. Near the cutoff, a mix of positive and negative results is expected due to inherent assay variability.
• Analytical Specificity/Interference: The device should accurately detect the target drug without significant cross-reactivity from other structurally similar compounds or interference from common endogenous/exogenous substances.
• Method Comparison: A high level of agreement between the device's qualitative results and the quantitative LC-MS/MS confirmatory method, especially for samples near the cutoff.
• Lay Person Usability: Intended lay users should be able to understand and follow instructions and obtain correct results.

2. Sample sizes used for the test set and the data provenance

• Analytical Performance (Precision/Reproducibility):

  • Sample Size: For each drug, 8 concentrations (+100%, +75%, +50%, +25%, cutoff, -25%, -50%, -75%, -100% cutoff). Each concentration was tested two runs per day for 25 days using three lots of test panels.
    • This means (8 concentrations * 2 runs/day * 25 days * 3 lots) = 1200 tests per drug.
  • Data Provenance: Samples were prepared by spiking target drugs into drug-free urine samples. The concentrations were confirmed by LC-MS/MS. This suggests controlled laboratory conditions. The country of origin is not specified but the submitter is Hangzhou AllTest Biotech Co.,Ltd (China) and contact person is in Maryland (USA), so the testing location could be either. Retrospective, as samples were prepared.

• Method Comparison Study:

  • Sample Size: For each drug, 80 unaltered urine clinical samples (40 negative and 40 positive).
  • Data Provenance: "Unaltered urine clinical samples." The source of these clinical samples (e.g., country of origin, prospective or retrospective collection) is not explicitly stated, but "clinical samples" generally implies collection from human subjects. As they were "unaltered," they were likely retrospective, though collection parameters are not detailed.

• Lay Person Study:

  • Sample Size: 140 lay persons.
  • Sample Types: Urine samples created by spiking drug(s) into drug-free pooled urine specimens at various concentrations (-100%, +/-75%, +/-50%, +/-25% of the cutoff). Each participant tested 1 blind-labeled sample. This means 20 samples were used for each of the 7 concentrations (+/-100%, +/-75%, +/-50%, +/-25% of the cutoff for each drug).
  • Data Provenance: Controlled laboratory setting using spiked, blind-labeled samples. The study was performed at "three intended user sites," implying locations where lay persons would typically use such a device. Country not specified. Retrospective setup using prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This device is not an AI-based medical device. Ground truth for the analytical and method comparison studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry), which is considered the gold standard for quantitative drug concentration measurement in urine. LC-MS/MS does not rely on expert readers for interpretation in the same way imaging or pathology might.
• For the lay person study, the ground truth was the known concentration of the spiked samples.

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

• Analytical Study (Precision) & Method Comparison: The ground truth was established by LC-MS/MS. The device's result was then compared to this LC-MS/MS reference. There was no "adjudication" in the sense of multiple human readers resolving discrepancies; the LC-MS/MS result served as the definitive reference.
• Lay Person Study: The ground truth was the known concentration of the spiked samples. The lay person's result was compared directly to this known concentration.

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 an in-vitro diagnostic test, not an AI-assisted diagnostic tool. Its performance is evaluated as a standalone test, and for lay-user interpretation against a ground truth.

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

• Yes, the "Precision/Reproducibility" and "Method Comparison Study" sections represent the standalone performance of the device (which is an immunochromatographic assay, not an algorithm) without human interpretation variability, as results were compared directly to LC-MS/MS.
• The "Lay Person Study" then evaluated human-in-the-loop performance (i.e., how lay users interpret the device's results).

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

• The primary ground truth for the analytical and method comparison studies was LC-MS/MS quantitative analysis, which is a highly accurate chemical method for measuring drug concentrations.
• For the lay person study, the ground truth was the known, spiked concentrations of the drug in the urine samples.

8. The sample size for the training set

• This document describes a 510(k) premarket notification for an in-vitro diagnostic device, not an AI/ML device. Therefore, there is no "training set" in the context of machine learning model development.

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

• As stated above, this is not an AI/ML device, so there is no "training set." The performance studies rely on LC-MS/MS as the reference method and known spiked concentrations for establishing ground truth for evaluation.

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