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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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The Chemtrue® Multi-Panel Drug Screen Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Phencyclidine, Ecstasy, Methadone, Oxycodone, Propoxyphene , Tramadol and Trivyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the tests are calibrated to are as follows:

The multi test panels can consist of any analytes listed above in any combination. Only one cut-off concentration will be included per analyte per device.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Benzodiazepines, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Antidepressants.

The Chemtrue® Drug Screen Fentanyl / Tramadol Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany! / Tramadol Dip Card Test detects and is calibrated against norfentanyl, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The tests provide only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentanyl/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Drug Screen Fentanyl / Tramadol Cup Tests are rapid lateral flow immunoassays for the qualitative detection of Norfentanyl 5 and Tramadol 100 drugs in human urine. It is an in vitro diagnostic device. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The Chemtrue® Drug Screen Fentany1 / Tramadol Cup Test detects and is calibrated against norfentany1, the major metabolite of fentanyl in human urine. The test is available in Single and multi-panels.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to the drug test result, particularly when preliminary positive result is indicated.

The test is not intended to differentiate between drugs of abuse and prescription use of Fentany/ Tramadol. The test is for in vitro diagnostic use only.

The Chemtrue® Multi-Panel Drug Screen Dip Card Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentany, Marijuana, Methadone, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Tricyclic Benzodiazepines, Antidepressants.

The Chemtrue® Multi-Panel Drug Screen Cup Test is a rapid lateral flow immunoassay for the qualitative detection of Amphetamine, Barbiturates, Benzodiazepines, Buprenorphine, Cocaine, Ecstasy, Norfentanyl, Marijuana, Methamphetamine, Morphine, Opiates, Oxycodone, Phencyclidine, Propoxyphene, Tramadol and Tricyclic Antidepressants (TCA) drugs in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The multi test panels can consist of any drug analytes listed above in any combination. Only one cutoff concentration will be included per analyte per device.

The test provides only a preliminary result. A more specific alternative chemical must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.

The tests are not intended to differentiate between drugs of abuse and prescription use of Tricyclic Benzodiazepines, Barbiturates, Buprenorphine, Oxycodone, Propoxyphene and Antidepressants.

The Chemtrue® Drug Screen Tests are colloidal gold-based lateral flow immunoassays for the rapid, qualitative detection of drugs of abuse in human urine. The tests are single-use, in vitro diagnostic devices, which come in Dip Card or Cup formats, as indicated by the test name.

The provided text describes the performance characteristics of the Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test and Dip Card Test. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative immunoassay diagnostic devices typically involve high levels of agreement with a reference method, especially around the cutoff concentration. While explicit acceptance criteria ("Pass/Fail" thresholds) are not directly stated in the provided text, the reported performance demonstrates very high agreement.

Note: The tables below focus on the Fentanyl (FYL) and Tramadol (TML) tests as these are the new additions being evaluated in this submission. Previous analytes were cleared under older 510(k)s. The percentages under "Reported Device Performance" are calculated from the provided raw counts.

Method Comparison (Accuracy) Studies vs. LC/MS Reference Method

The agreement is calculated as (Number of correct results / Total number of samples in that category) * 100%.

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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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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine. Oxazepam. Marijuana. Methamphetamine, Morphine. Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations of:

Configuration of SAFECARE® Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

The tests are intended for over-the-counter use.

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the performance characteristics and studies for the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. It does not describe an AI/ML device but rather an in-vitro diagnostic device (IVD) for drug screening. Therefore, several of the requested categories for AI/ML device evaluation are not applicable (e.g., number of experts, adjudication method, MRMC study, standalone performance, training set).

Here's the information extracted from the document, tailored to the nature of the device:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by precision around the cutoff concentration. The device is expected to consistently classify samples below the cutoff as negative and above the cutoff as positive. For samples near the cutoff, some variability in classification is expected.

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Study (Test Set):

  • For each drug (Amphetamine, Cocaine, Methamphetamine, Morphine), 9 concentrations were tested around the cutoff (-100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100%).
  • For each concentration, tests were performed two runs per day for 25 days, using 3 different lots of the device. This equates to 50 replicates per concentration per lot, totaling 450 tests per lot per drug.
  • Total replicates for 4 drugs (AMP, COC, MET, MOP): 9 concentrations x 50 replicates/concentration x 3 lots = 1350 tests per drug. (Some data for other drugs were referenced from prior 510(k)s: K182654, K181968, K153646, K201120).
  • Data Provenance: The document states "in-house" for comparison studies and "urine samples were prepared by spiking drug in negative samples" for precision studies. This suggests a controlled laboratory setting (likely prospective, artificial samples). The document does not specify the country of origin of the data.

• Method Comparison Study (Clinical/Test Set):

  • 80 "unaltered clinical samples" were used for each drug. These samples were split into categories: 10 negative, 10 low negative, 20 near cutoff negative, 20 near cutoff positive, 20 high positive for each drug.
  • Total samples per device type (Dip Card or Cup) for 4 drugs mentioned: 80 samples x 4 drugs = 320 samples per device type.
  • Data Provenance: "in-house" and "unaltered clinical samples," implying real-world samples but processed within the manufacturer's lab. The document does not specify the country of origin or whether these clinical samples were retrospective or prospectively collected for the study.

• Lay-User Study (Test Set):

  • 310 lay persons participated for each device format (Dip Card and Cup).
  • Urine samples were prepared at 7 concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff.
  • Total samples: For each drug, the number of samples varied across concentrations. For example, for AMP500, 20 samples at -100% cutoff, 20 at -75%, 170 at -50%, 20 at -25%, 20 at +25%, 40 at +50%, 20 at +75%. This totals 310 samples per drug per device format.
  • Data Provenance: "at three intended user sites." Samples were "prepared by spiking drugs into drug free-pooled urine specimens," making them artificial but intended to mimic a range of concentrations. This suggests a prospective study design, mimicking real-world use conditions but with controlled samples.

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

• Precision Study: Ground truth was established by preparing urine samples with known drug concentrations confirmed by LC/MS. No human experts were involved in establishing ground truth, as it was an analytical study.
• Method Comparison Study: The ground truth for clinical samples was established by LC/MS results. No mention of human experts for ground truth.
• Lay-User Study: Ground truth was established by LC/MS results of the prepared spiked urine samples.

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

• Not applicable. This device is a qualitative diagnostic test read directly by users, not an AI/ML imaging device requiring expert adjudication. In the method comparison study, three laboratory assistants "ran" the samples, implying they performed the test, but the ground truth was LC/MS, not their consensus.

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 is not an AI/ML device, and no MRMC study comparing human readers with and without AI assistance was mentioned. The lay-user study evaluated the device's performance with lay users, not an "AI assistance" scenario.

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

• Not applicable. The device is a physical, lateral flow immunochromatographic assay. Its performance inherently involves a human interpreting the result line, even if it's a simple positive/negative visual interpretation. It is not an algorithm-only device. The precision and method comparison studies evaluate the device's analytical performance, which is its inherent "standalone" capability.

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

• LC/MS (Liquid Chromatography-Mass Spectrometry) was used as the ground truth method to confirm drug concentrations in both spiked samples (for precision and lay-user studies) and clinical samples (for method comparison studies). This is a highly accurate and quantitative analytical method.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a "training set" in the machine learning sense. The device is based on immunoassay principles.

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

• Not applicable, as there is no training set for an AI/ML device.

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SAFECARE® Multi-Drug Urine Test Dip Card is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Propoxyphene 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

SAFECARE® Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline d-Propoxyphene and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (EDDP) in human urine at the cutoff concentrations listed. The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. The tests are intended for over-the-counter use.

The SAFECARE® Dip Card Tests and SAFECARE® Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Morphine, Secobarbital, Methadone, Methylenedioxymethamphetamine, Oxycodone, Buprenorphine, Phencyclidine, Nortriptyline, Propoxyphen and 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine (target analytes) in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided text describes the performance characteristics of the SAFECARE® Multi-Drug Urine Test Dip Card and SAFECARE® Multi-Drug Urine Test Cup. The document details analytical performance (precision, linearity, stability, interference, specificity, effect of specific gravity and pH) and comparison studies (method comparison and lay-user study).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each analytical performance characteristic are implicitly defined by the successful results reported in the study. The study aims to demonstrate that the device performs as expected according to its intended use and analytical specifications.

• Precision:

  • Acceptance Criteria for -100% to -25% Cut-off: All samples should test negative.
  • Acceptance Criteria for +25% to +100% Cut-off: All samples should test positive.
  • Acceptance Criteria for Cut-off (nominal concentration): Approximately 50% positive and 50% negative results (reflecting the nature of the cut-off).
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Dip Card (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 24-/26+, 25-/25+, 26-/24+ (Split between positive and negative, as expected)
    • Cup (Lot 1, 2, 3):
      • -100% Cut-off to -25% Cut-off: 50-/0+ (All negative)
      • +25% Cut-off to +100% Cut-off: 50+/0- (All positive)
      • Cut-off: 27-/23+, 24-/26+, 26-/24+ (Split between positive and negative, as expected)

• Interference:

  • Acceptance Criteria: No interference from common physiological or pathological substances at specified concentrations.
  • Reported Device Performance: No interference observed for a comprehensive list of compounds at 100ug/mL (except albumin at 100mg/dL and ethanol at 1% volume).

• Specificity (Cross-Reactivity):

  • Acceptance Criteria: Related compounds should either not cross-react or cross-react at concentrations significantly higher than the cut-off, as defined by medical relevance.
  • Reported Device Performance (for 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine as an example):
    • Methadone: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • EMDP: Positive at 300000 ng/mL (0.1% cross-reactivity)
    • Doxylamine, Disopyramide, LAAM HCl, Alpha Methadol: Positive at >100,000 ng/mL (

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BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch

The provided document describes the performance of the BIOEASY Multi-Drug Test Cup, an in-vitro diagnostic device for qualitative and simultaneous detection of various drugs in human urine. Here's a breakdown of the acceptance criteria and study details:

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

The document doesn't explicitly state "acceptance criteria" in a separate table. However, the performance is demonstrated through precision studies and lay-user studies, showing the device's ability to correctly identify drug presence/absence at specific concentrations relative to the defined cutoff levels. The implicit acceptance criteria appear to be high percentages of correct results, particularly at and beyond the +/- 25% cutoff concentrations. For the lay user study, 90-100% correct results were generally achieved across different drug panels and concentrations close to the cutoff, with 100% correct results for samples far from the cutoff.

Here's an aggregated summary of the performance for each drug panel from the lay user study, which serves as a key indicator of device performance in the hands of intended users:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Studies: For each drug concentration point tested (-100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off, and +100% cut off), tests were performed for 25 days per device, with two runs per day for each drug. This means 50 runs per concentration for each drug across three lots (total of 150 runs per concentration per drug across lots). The samples were prepared in-house by spiking drugs into negative samples. The data provenance is implied to be from the manufacturer's lab, likely Shenzhen, China, where the submitter is located. This appears to be a prospective internal study.
• Method Comparison Studies: 80 (40 negative and 40 positive) unaltered clinical samples for each drug were used. The samples were blind labeled. These appear to be retrospective clinical samples, but the country of origin is not specified.
• Lay-user Study: 300 lay persons participated. Urine samples were prepared at varying concentrations: negative, +/-75%, +/-50%, +/-25% of the cutoff. Each participant received one blind-labeled sample and one device. The number of samples tested at each concentration varied per drug, as shown in the tables (e.g., 20 samples for -100% cutoff, 160 for -50% cutoff, 40 for +50% cutoff). These were likely prepared in-house or externally for the study, making it a prospective study, though the country of origin for the lay users is not specified (but likely related to the submitter's regions of operation or intended market).

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)

• Precision and Lay-user Studies: The "ground truth" for the urine samples in these studies was established by LC/MS (Liquid Chromatography/Mass Spectrometry) or LC/MS/MS, which is a gold standard analytical method for drug concentration determination. The number or qualifications of the individuals performing the LC/MS analysis are not specified, but it's presumed to be trained laboratory personnel.
• Method Comparison Studies: The ground truth for the 80 clinical samples was also established by LC/MS. The number or qualifications of the individuals performing the LC/MS analysis are not specified.

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

• Precision Studies: The document doesn't explicitly state an adjudication method. "All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing." The results presented are counts of "positive" and "negative" outcomes.
• Method Comparison Studies: The studies were performed in-house with three laboratory assistants for each device. The results are summarized by "Viewer A," "Viewer B," and "Viewer C." This indicates a multi-reader approach. However, there's no mention of an adjudication process (e.g., 2+1, 3+1) if their readings disagreed. The discordant results table lists individual discrepancies.
• Lay-user Study: Each participant tested one device and recorded their results. The assessment of whether their result was "correct" was based on the LC/MS confirmed concentration of the sample they received. No adjudication among lay users is mentioned or appropriate for this type of study.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not done. This device is a lateral flow immunoassay, a point-of-care test that human users (including lay users) interpret visually. It is not an AI-assisted diagnostic device.

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

No, a standalone algorithm-only performance study was not done, as this device does not incorporate an AI algorithm. Its performance is based on the chemical reaction and visual interpretation.

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

The ground truth used for validating the device's performance was primarily analytical confirmation by LC/MS or LC/MS/MS. This is considered a highly accurate and quantitative laboratory diagnostic method for determining drug concentrations.

8. The sample size for the training set

The document does not describe a "training set" in the context of an AI/ML algorithm. This device is a lateral flow immunoassay and does not employ machine learning or AI that would require a separate training dataset. The studies described are for analytical and clinical validation of the immunoassay.

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

As there is no AI/ML component mentioned and thus no "training set," this question is not applicable to the information provided.

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Atlas Multi-Drugs Screening Test Cup and Atlas Multi-Drugs Screening Test Panel are lateral flow chromatographic in vitro diagnostics immunoassays for the qualitative detection of following drugs in urine without the need of instruments: Amphetamine (AMP), Methylenedioxymethamphetamine (MDMA), Morphine (MOP), Oxycodone (OXY), Cocaine (COC), Nortriptyline, Methamphetamine (MET), Phencyclidine (PCP), Marijuana (THC), Secobarbital, Oxazepam, Methadone (MTD), Propoxyphene (PPX), Buprenorphine(BUP). The tests are intended for professional use only. The tests will yield preliminary positive results when the prescription drugs Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Secobarbital, oxazepam, Buprenorphine, Oxycodone, Propoxyphene, and Nortriptyline in urine. The multi-drugs screening tests (Cup and Panel formats) show the drug was or was not present at the cutoff level. The tests provide only preliminary test results, which must be confirmed by other methods such as gas chromatography/mass spectrometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. The tests are not intended to be used in monitoring the drug levels.

Atlas Multi-Drugs Screening Test cup format is single use device. The user collects urine in the cup to the recommended volume. The reaction is initiated by movement the sample to the strip. The strips are incorporated into the sides of sample cup. Atlas Multi-Drugs Screening Test panel format is single use dip card device. The user inserts the absorbent end of the device in the urine sample to the maximum level indicated by the line on the device label. The test reaction is initiated by movement of the sample through the strip. Atlas Multi-Drugs Screening Tests (Cup and Panel Formats) detect up to 14 drugs.

Here's a breakdown of the acceptance criteria and study information for the Atlas Multi-Drugs Screening Test Cup and Panel, extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision and analytical sensitivity studies, which show the device consistently performs around its cut-off values. The clinical study indicates a high percentage of agreement with GC/MS or LC/MS.

• % Agreement Among positive: 95%-100% (e.g., AMP 100%, THC 95%, PCP 100%).
• % Agreement Among negative: 95%-100% (e.g., AMP 98%, THC 100%, PCP 95%). |
  | Real-Time Stability | Stable for 24 months at 2-30°C. | The device was found stable for 24 months at 2-30°C. |
  | Accelerated Stability | Stable for at least 24 months based on accelerated testing. | Based on accelerated testing, the device is expected to be stable for at least 24 months. |

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

• Precision Study:
  • Sample Size: For each drug, 9 different concentrations (ranging from -100% cut-off to +100% cut-off) were tested. Each concentration was tested with 15 tests (5 tests from each of 3 lots) for a total of 135 tests per drug. Across 14 drugs, this would be a total of 1890 tests per format (Cup and Panel).
  • Data Provenance: Not explicitly stated, but the sample preparation involved spiking drugs into "prepared samples." This suggests laboratory-controlled samples rather than purely clinical, patient-derived samples for the precision study.
• Analytical Sensitivity Study:
  • Sample Size: For each drug, 5 different concentrations (Drug free, Cut-off-50%, Cut-off-25%, Cut-off+25%, Cut-off+50%) were tested. 25 samples were used for each concentration. Therefore, for each drug, 125 tests were performed. For 14 drugs, this amounts to 1750 tests per format (Cup and Panel).
  • Data Provenance: "Drug-free urine pool was spiked with drugs." This indicates laboratory-prepared samples.
• Analytical Specificity and Cross Reactivity Study:
  • Sample Size: Not explicitly stated as a fixed number of samples, but implied to be a series of tests to determine the concentration at which cross-reacting substances are detected or not detected.
  • Data Provenance: Laboratory-prepared samples with specific compounds and target drugs.
• Interference Study:
  • Sample Size: "Drug-free urine samples were collected." Each sample was spiked with drugs at cut-off-25%, cut-off, and cut-off+25%. These samples were then spiked with 100 ug/ml of various interfering substances (albumin at 20 mg/mL). The number of individual tests per interfering substance or per concentration is not specified, but the number of interfering substances is extensive (over 70 listed).
  • Data Provenance: "Drug-free urine samples were collected," which could be clinical or laboratory-sourced. The spiking process makes them laboratory-controlled for interference testing.
• Effect of pH Study:
  • Sample Size: Samples spiked with drugs at cut-off-25%, cut-off, and cut-off+25% at 5 different pH values (4.5, 5, 6, 7, 8, 9).
  • Data Provenance: "Drug-free urine samples were collected... spiked with drugs." Laboratory-controlled.
• Effect of Specific Gravity Study:
  • Sample Size: Samples spiked with drugs at cut-off-25%, cut-off, and cut-off+25% at 4 different specific gravity values (1.005, 1.015, 1.025, 1.030).
  • Data Provenance: "Drug-free urine samples were collected... spiked with drugs." Laboratory-controlled.
• Clinical Study (Method Comparison):
  • Sample Size: 80 clinical specimens were tested for each drug.
  • Data Provenance: Clinical specimens. "All samples used in this study belong to adults (males and females) with ages 18+." "PCP samples which were diluted as per the table mentioned below in the study due to difficulty in sourcing PCP real samples." The cohort also uses 27 other negative urine samples confirmed by GC/MS or LC/MS methods. This indicates a mix of prospectively collected general clinical samples and some retrospectively sourced/modified samples for specific drugs (PCP). The country of origin is not explicitly stated.

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

• Clinical Study (Method Comparison): The ground truth for the clinical study was established by GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry). These are established analytical laboratory methods, not human expert consensus for this type of test. Therefore, human experts were not used to establish the ground truth in the traditional sense of medical image interpretation. The "experts" would be the laboratory personnel performing and interpreting the GC/MS or LC/MS results, who are usually highly qualified with specialized training and certifications in analytical chemistry and toxicology (e.g., clinical chemists, toxicologists). Their specific number or detailed qualifications are not provided in this document.

4. Adjudication Method for the Test Set

• For the clinical study, the reference method (ground truth) was GC/MS or LC/MS. Discordant results between the device and the reference method were analyzed, but there is no mention of an independent adjudication process involving human readers. The GC/MS/LC/MS results are considered the definitive ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a "Multi-Reader Multi-Case (MRMC) comparative effectiveness study" comparing human readers with and without AI assistance was not mentioned, nor is it typically applicable to a rapid in-vitro diagnostic immunoassay like this, which is read visually by a single user. The device's performance is determined by its analytical accuracy against a gold standard (GC/MS/LC/MS) and its visual interpretability by a single user.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)

• Yes, the entire performance evaluation presented for the Atlas Multi-Drugs Screening Test Cup and Panel is a standalone performance study. The device itself (the immunoassay) is the 'algorithm' in this context, and its performance is evaluated directly against known concentrations and against reference laboratory methods (GC/MS/LC/MS). Human operators are involved in running the tests and reading the visual results, but the performance metrics (precision, sensitivity, specificity, agreement with GC/MS/LC/MS) are attributed to the device's inherent capability, not as an aid to human interpretation.

7. Type of Ground Truth Used

• Precision, Analytical Sensitivity, Cross-Reactivity, Interference, pH, Specific Gravity Studies: Laboratory-prepared samples with known concentrations of drugs and interfering substances.
• Clinical Study (Method Comparison): GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry) results are used as the ground truth. These are considered the gold standard analytical methods for drug detection and quantification in urine.

8. Sample Size for the Training Set

• This is a lateral flow immunoassay device, not an AI/Machine Learning algorithm that typically requires a distinct "training set." Therefore, there is no explicit training set sample size described in the context of an AI algorithm. The device's design and manufacturing process would be informed by prior research and development, but not in the sense of an algorithmic training data set.

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

• As there is no explicit "training set" for an AI/ML algorithm in this context, this question is not applicable. The device's inherent performance is based on its biochemical design and manufacturing, which is validated through the studies described above.

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The Single and Multi-Drug Rapid Test Cup With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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.

For Prescription Use.

The Single and Multi-Drug Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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.

For Prescription Use.

The Single and Multi-Drug Rapid Test Panel With Adulteration (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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.

For Prescription Use.

The Single and Multi-Drug Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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.

For Prescription Use.

The Single Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/ mL, and 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

This assay provides only a preliminary analytical test result. A more specific alternate chemical 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.

For Prescription Use.

The Single and Multi-Drug Home Rapid Test Cup (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, Marijuana 50ng/mL, Methadone 300ng/mL, Methamphetamine 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

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.

For Over-The-Counter use.

The Single and Multi-Drug Home Rapid Test Panel (Urine) are rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL, Methadone 300ng/mL, Methamphetamine Mariiuana 500ng/mL, Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

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.

For Over-The-Counter use.

The Single Drug Home Drug Rapid Test Dipstick (Urine) are rapid chromatographic immunoassay for the qualitative detection of individual drug and drug metabolite(s) in urine at the following cut-off concentrations: Amphetamine 500ng/mL, Secobarbital 300ng/mL, Benzodiazepines 300ng/mL, Buprenorphine 10ng/mL, Cocaine 150ng/mL, 50ng/mL. Methadone Marijuana 500ng/mL. Methylenedioxymethamphetamine 500ng/mL, Morphine 300ng/mL and 2,000ng/mL, Phencyclidine 25ng/mL, Nortriptyline 1,000ng/mL, Oxycodone 100ng/mL, and 2ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine 300ng/mL.

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.

For Over-The-Counter use.

The Candidate Drug Screen Tests are rapid lateral flow immunoassays in which drugprotein conjugates in the test device compete with drugs or drug metabolites that may be present in urine.

On each test strip, a drug-protein conjugate is added to the test band of the membrane known as the test region (T), and the anti-drug antibody-colloidal gold conjugate pads are placed at the forward end of the membrane. Anti-drug antibodies derived from sheep and/or mice are used on the candidate tests. If target drugs are present in the urine specimen below its cut-off concentration, the solution of the colored antibody-colloidal gold conjugates moves along with the sample solution by capillary action across the membrane to the immobilized drug-protein conjugate zone on the test band region. The colored antibody- gold conjugates then complexes with the drug-protein conjugates to form visible lines.

Therefore, the formation of the visible precipitant in the test band indicates a negative result. If the target drug level exceeds its cut-off concentration, the drug/metabolite antigen competes with drug protein conjugates on the test band region for the limited antibody on the colored drug antibody-colloidal gold conjugate pad. The drug will saturate the limited antibody binding sites and the colored antibody-colloidal gold conjugate cannot bind to the drug-protein conjugate at the test region of the test strip. Therefore, absence of the color band on the test region indicates a preliminary positive result. A band should form in the control region (C) of the devices regardless of the presence of drug in the sample to indicate that the test has been performed properly.

The provided text describes several rapid chromatographic immunoassay devices for the qualitative detection of drugs and drug metabolites in urine. The 510(k) summary (K182738) states that the devices are substantially equivalent to a predicate device (K173303) from Guangzhou Wondfo Biotech Co., Ltd.

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

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

The document does not explicitly state "acceptance criteria" or provide a table of performance data for the submitted device (Hangzhou AllTest Biotech Co., Ltd). Instead, it states that "The results of all verification and validation activities demonstrate that the candidate device is substantially equivalent to the cleared predicate devices." This implies that the device's performance met the standards required for substantial equivalence, which would align with the predicate device's established performance. The specific performance metrics (e.g., sensitivity, specificity, accuracy) are not detailed.

However, the "Cutoff Levels" section under "Comparison to Predicate Devices" acts as a form of performance characteristic.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective. It summarily states "The results of all verification and validation activities demonstrate that the candidate device is substantially equivalent to the cleared predicate devices."

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)

The document does not specify the number or qualifications of experts used to establish the ground truth. It mentions that Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method for obtaining a confirmed analytical result, implying that GC/MS provides the ground truth.

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

The document does not describe any adjudication method.

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

This is an immunoassay device, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

This refers to the performance of the immunoassay device itself, which operates as a standalone test. The document states it is a "rapid chromatographic immunoassay for the qualitative detection of single or multiple drugs and drug metabolites in urine." While the specific performance metrics are not given, the whole 510(k) submission relates to the standalone performance of this device. The phrase "This assay provides only a preliminary analytical test result" indicates its standalone (screening) utility.

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

The preferred confirmatory method mentioned is Gas Chromatography/Mass Spectrometry (GC/MS). This indicates that GC/MS results serve as the ground truth for confirming the presence and concentration of drugs and drug metabolites in urine samples.

8. The sample size for the training set

The document does not explicitly mention a training set or its sample size. Immunoassays typically undergo analytical validation rather than machine learning training.

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

As there is no mention of a training set in the context of machine learning, this question is not applicable. For analytical validation of immunoassays, ground truth (if a "training set" were to be conceptualized as samples used for assay development/optimization) would be established by highly accurate methods like GC/MS.

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BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine.

Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:

The cassette test may be configured as single drug test in any drug analytes listed in the table.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The test is intended for over the counter use.

BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam,

Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:

The cassette test may be configured as single drug test in any drug analytes listed in the table.

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The test is intended for prescription use.

The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained

The document describes the performance of the BIO-VENTURE Rapid Amphetamine Test Cassette and similar rapid test cassettes for other drugs (Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana). These are qualitative lateral flow immunoassays designed for both OTC and Rx use.

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

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their ability to accurately distinguish between drug concentrations above and below specified cut-off levels. The primary performance metrics presented are precision, cut-off verification, interference, specificity, and comparison with GC/MS results. For the lay-user study, the acceptance criteria are a high percentage of correct results near the cut-off concentrations and ease of use/understanding for lay users.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Precision Study: For each drug assay (AMP, COC, Oxazepam, MET, MOP, THC), there were 6 drug concentrations tested (from -100% to +100% cut-off, skipping -75%, +75%, and -50%, but then showing -75% and +75% in the table). Each concentration likely involved multiple replicates over 25 days across 3 lots and 6 operators.
     • The tables show results for 6 concentrations per lot, with 50 results per concentration (e.g., 50-/0+ means 50 negative, 0 positive). With 3 lots and 6 operators, performing 9 samples for 25 days per device, this is a very large number of total tests, difficult to sum precisely from the given table format for all concentrations. However, for a given concentration and lot, it appears 50 tests were performed (e.g., 50-/0+).
   • Cut-off Verification: 125 samples tested per drug (equally distributed at -50%, -25%, Cut-Off, +25%, +50% cut-off). Tested using three different lots of each device by three different operators.
   • Interference & Effect of Specific Gravity/pH: Not explicitly stated, but implies a similar number of samples at 25% below and 25% above cut-off for each interference/pH/SG factor.
   • Comparison Studies (Clinical Samples):
     • Amphetamine: 87 samples
     • Cocaine: 80 samples
     • Oxazepam: 80 samples
     • Methamphetamine: 81 samples
     • Morphine: 81 samples
     • Marijuana: 82 samples
   • Lay-User Study: For each drug, 20 samples were tested at each of 7 concentration levels (total 140 samples per drug type).
   • Data Provenance: Not explicitly stated regarding country of origin for the clinical samples. The precision samples were prepared by spiking drug in negative samples. The clinical samples were "unaltered clinical samples." The studies were performed "in-house" and at "three intended user sites" (for the lay-user study). The document refers to Shanghai Venture Bio-Tech CO., Ltd. in China, suggesting an origin in China for the test execution, though clinical samples might be from other regions. The studies are prospective in nature, as they involve testing samples under controlled conditions to evaluate device performance.

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

   • For the Precision Study, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is considered the preferred confirmatory method for drug testing, thus a highly accurate and objective ground truth method. The document states: "Each drug concentration was confirmed by GC/MS."
   • For the Method Comparison Studies (Clinical Samples), the ground truth was also established by GC/MS results. The samples were "compared to GC/MS results."
   • For the Lay-User Study, the concentrations of the samples were also confirmed by GC/MS.
   • The document does not explicitly state the number or qualifications of experts (e.g., radiologists) involved in establishing ground truth, as the ground truth here is analytical (GC/MS) rather than expert consensus on medical images.

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

   • No adjudication method (like 2+1 or 3+1 expert consensus) is mentioned. The ground truth for all performance studies (precision, method comparison, lay-user study) was based on GC/MS, which is an objective chemical method and generally does not require human adjudication in the same way image interpretation might. For the clinical sample comparison, the device results were simply compared against the GC/MS result.

4. 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:

   • This is not applicable to the described device. The device is a rapid diagnostic test (lateral flow immunoassay) for detecting drugs in urine, not an AI-assisted diagnostic tool for human readers interpreting medical images. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

   • This is generally applicable because the device itself is a standalone test that produces a visible result (lines on a cassette). Its performance is evaluated independently.
   • The "Comparison Studies" with clinical samples and the "Precision Studies" are forms of standalone performance evaluation for the device when operated by trained laboratory personnel.
   • The "Lay-user study" also assesses the device's standalone performance, but crucially, it evaluates how well untrained individuals can interpret the device's results.

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

   • The primary ground truth used for all performance evaluations (precision, clinical comparison, lay-user study samples) was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the laboratory gold standard for confirming drug presence and concentration.

7. The sample size for the training set:

   • The document describes a medical device (rapid immunoassay cassette), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The device's "training" corresponds to its chemical and physical design and manufacturing process.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no AI/ML training set. The ground truth for the testing of these devices was established using GC/MS.

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BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over the counter use.

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

It seems you're asking for a structured summary of the acceptance criteria and study results for the "BIO-VENTURE Rapid Multi-Drug Test Easy Cup" and "Split Key Cup" devices, based on the provided FDA 510(k) summary.

Please note that this document describes a qualitative diagnostic test, not an AI-powered device or an imaging system. Therefore, some of your requested points related to AI/MRMC studies, expert readers, and ground truth establishment for complex image analysis are not applicable to this type of device. I will address only the relevant information from the provided text.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for BIO-VENTURE Rapid Multi-Drug Test Easy Cup / Split Key Cup

Device Description:
The BIO-VENTURE Rapid Multi-Drug Test Easy Cup and Split Key Cup are rapid lateral flow immunoassays for the qualitative detection of specific drugs (d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH) in human urine. They provide preliminary test results, and a confirmatory chemical method (e.g., GC/MS) is required for confirmed analytical results.

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance data through precision studies, specificity studies, interference studies, effect of urine specific gravity and pH studies, and comparison to GC/MS studies (clinical samples), as well as a lay-user study.

Acceptance Criteria (Implicit from Study Design and Passed Results):
The acceptance criteria are implicitly defined by the successful demonstration of the device's ability to consistently provide correct qualitative results (positive or negative) within specified concentration ranges relative to the cut-off levels, when compared to a gold standard (GC/MS) and under various testing conditions. For precision, a high concordance rate around the cut-off is expected. For linearity, showing all positive above +25% cut-off and all negative below -25% cut-off. For interference and specificity, showing no false positives or negatives due to common interfering substances or closely related compounds (unless cross-reactivity is expected and quantified). For lay-user studies, a high percentage of correct results by untrained users.

Reported Device Performance (Key Findings from Studies):

Precision Studies (Analytical Performance):

• Sample Concentrations: -100%, -75%, -50%, -25%, Cut off, +25%, +50%, +75%, +100% of cut-off.
• Method: Samples prepared by spiking drug in negative urine, confirmed by GC/MS. Blindly labeled.
• Results (Summary across all drugs and both cup types):
  • Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine, THC:
    • All samples concentrated at or below -25% cut-off consistently showed Negative results (e.g., typically 50-/0+ for all concentrations from -100% to -25%).
    • All samples concentrated at or above +25% cut-off consistently showed Positive results (e.g., typically 50+/0- for all concentrations from +25% to +100%).
    • Samples at the cut-off concentration showed a mix of positive and negative results, which is expected for a qualitative immunoassay at its detection threshold (e.g., for AMP Split Key Cup, Cut off: 22-/28+ to 25-/25+ across batches, meaning 22-25 negative and 25-28 positive out of 50 samples). This demonstrates the device's ability to discriminate around the cut-off.

Linearity (Analytical Performance):

• Results: "Not applicable" in the document, as it's a qualitative test. However, the Cut-off verification study (5.8.1.d) serves a similar purpose.
• Cut-off Verification: A total of 375 samples per device type (Easy Cup, Split Key Cup) across -50%, -25%, Cut-Off, +25%, +50% concentrations.
  • Results: "Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine and Marijuana." This verifies the device's threshold performance.

Stability:

• Result: Stable at 2-30 ℃ for 24 months based on real-time stability.

Interference and Specificity (Analytical Performance):

• Interference: Various physiological/pathological substances (e.g., Naltrexone, Aspirin, Bilirubin, Ethanol) were tested at high concentrations (100 µg/mL or 1% for Ethanol) in drug-free urine and urine spiked at +/- 25% of cut-off.
  • Result: "Compounds that showed no interference at a concentration of 100µg/mL and Ethanol at 1% are summarized in the following tables." The tables list numerous compounds that did not interfere, indicating good specificity against common physiological/pharmaceutical substances.
• Specificity (Cross-Reactivity): Related drug metabolites and other components were tested.
  • Result: Tables provided the lowest concentration causing a positive result and the % cross-reactivity for various substances (e.g., for Amphetamine, D/L-Amphetamine showed 66.7% cross-reactivity at 1500ng/mL; MDMA shows 100,000 ng/mL). This quantifies how other substances react with the test and confirms appropriate specific binding.

Effect of Urine Specific Gravity and Urine pH (Analytical Performance):

• Method: Urine samples with SG 1.002-1.036 or pH 4-9 spiked at +/- 25% of cut-off.
• Result: "Results were all positive for samples at and above +25% Cutoff and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices." This confirms robust performance across a range of physiological urine conditions.

2. Sample Sizes and Data Provenance

• Training Set: The document does not explicitly state a separate "training set" in the context of machine learning, as this is a traditional immunoassay device. The analytical and comparison studies effectively serve as the validation of the device's performance characteristics.
• Test Set (Analytical Performance - Precision):
  • Sample Size: Each drug concentration (9 levels per drug) for 3 lots, tested by 6 operators, with 9 samples per operator per day for 25 days. This results in: 9 concentrations * 3 lots * 6 operators * 9 samples/operator/day * 25 days = 36,450 individual test results for each drug (AMP, COC, OXA, MET, MOP, THC) across all precision studies.
  • Data Provenance: Samples were "prepared by spiking drug in negative samples" and confirmed by GC/MS. This suggests controlled laboratory conditions. The document is for a Chinese manufacturer (Shanghai Venture Bio-Tech Co., Ltd.), so the studies were likely conducted in China or a related territory, but this is not explicitly stated. It's a prospective study as samples were prepared and tested to evaluate device precision.
• Test Set (Clinical Comparison Study):
  • Sample Size:
    • Amphetamine: 87 samples
    • Cocaine: 80 samples
    • Oxazepam: 80 samples
    • Methamphetamine: 81 samples
    • Morphine: 81 samples
    • Marijuana: 82 samples
  • Data Provenance: "unalred clinical samples" tested "in-house." The specific country of origin for these clinical samples is not stated, but given the manufacturer, it's likely China. This is a retrospective study in the sense that existing clinical samples were tested.
• Test Set (Lay-User Study):
  • Sample Size: 20 samples per concentration level (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off) for each of the 6 drugs and each cup format (Easy Cup, Split Key Cup). Total samples: 7 concentration levels * 20 samples/level = 140 samples per drug per cup type. Multiplying by 6 drugs and 2 cup types gives 1,680 total tests by lay users. Each participant was provided with 1 blind labeled sample and a device.
  • Data Provenance: Samples "prepared at the following concentrations... by spiking drug(s) into drug free-pooled urine specimens." Confirmed by GC/MS. The "lay users" were diverse in background and age, but their geographic location is not specified beyond "three intended user sites" which likely refers to testing locations rather than sample origin. This is a prospective study.

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

• Ground Truth Method: The primary ground truth for the analytical and clinical comparison studies was Gas Chromatography/Mass Spectrometry (GC/MS). GC/MS is a highly accurate and established analytical method used in toxicology for confirmed analytical results of drug concentrations.
• Experts for GC/MS: The document does not specify the number or qualifications of experts operating the GC/MS. GC/MS testing typically requires trained laboratory professionals, but they are not "experts" in the sense of clinical interpretation as in imaging studies. Their expertise lies in analytical chemistry and operating the GC/MS equipment according to established protocols.
• Experts for Device Studies: The clinical comparison studies were performed "in-house with three laboratory assistants for each device." These assistants performed the device testing, but the ground truth was GC/MS. For the lay-user study, the results were compared against GC/MS concentrations.

4. Adjudication Method for the Test Set

• For Lab-based (Precision & Clinical Comparison): The results of the rapid test were compared directly to the quantitative GC/MS results. Discordant results are explicitly listed and discussed. There's no specific "adjudication method" among human readers mentioned, as this is a chemical test, not subjective interpretation.
• For Lay-User Study: The lay users performed the test, and their qualitative results were compared against the GC/MS quantitative concentration data. There was no adjudication mentioned for the lay-user results themselves; rather, their output (positive/negative) was assessed for correctness against the GC/MS reference.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for imaging devices where human readers interpret medical images, and the AI assists or performs this interpretation. This document describes a qualitative immunoassay (drug test), which does not involve human readers interpreting complex cases in the same way. The studies focused on the analytical performance of the device itself and its accuracy against a chemical gold standard (GC/MS).

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

Yes, in essence, the analytical performance and comparison studies represent the "standalone" performance of the device.

• The device itself provides a qualitative result (visible line or no line).
• The precision studies, cut-off verification, interference, and specificity sections evaluate the device's performance in a controlled lab setting, without human interpretation variability being the primary focus (though lab assistants operated the device).
• The comparison study also evaluates the device's direct output (positive/negative) against GC/MS, effectively assessing its standalone accuracy.
• The lay-user study assesses how accurately untrained individuals can use and interpret the device, which is different from "human-in-the-loop" in an AI diagnostic context.

7. The Type of Ground Truth Used

The primary ground truth used for all performance evaluations (precision, linearity/cut-off, clinical comparison, lay-user study) was Gas Chromatography/Mass Spectrometry (GC/MS). For an immunoassay, GC/MS provides a highly accurate and quantitative measurement of the target drug concentration, which serves as the definitive reference for determining whether a sample is truly positive or negative relative to a defined cut-off.

8. The Sample Size for the Training Set

As mentioned, this document does not describe an AI/machine learning device. Therefore, a distinct "training set" in the machine learning sense is not applicable. The development and optimization of the immunoassay itself would have involved numerous experiments and iterations (e.g., antibody selection, membrane optimization), but these are part of the device's manufacturing process, not a data-driven training phase for an algorithm.

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

Since there is no "training set" in the context of an AI algorithm, this point is not applicable. The device's "ground truth" for development and validation was established by using precisely prepared samples with known drug concentrations, confirmed by GC/MS.

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