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The DRI™ Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL. The product is intended for use in clinical laboratories only.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/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 used.

DRI Ecstasy Plus Assay is a homogeneous enzyme immunoassay intended for the qualitative or semiquantitative determination of ecstasy drugs in human urine. The assay provides a simple and rapid analytical screening procedure for detecting ecstasy drugs at a cutoff level of 500 ng/mL.

DRI Ecstasy Plus Assay is a class assay. Ecstasy drugs represent a group of ring substituted methylenedioxy analogues of amphetamine including 3, 4 methylenedioxyamphetamine (MDA), 3, 4 - methylenedioxymethamphetamine (MDMA) and 3, 4 - methylenedioxyethylamphetamine (MDEA). They are central nervous system (CNS) stimulants popularly abused for their psychotropic effects and are listed by the U.S. Drug Enforcement Administration as Schedule | (no accepted medical application with great abuse potential).

The provided document is a 510(k) Pre-market Notification from the FDA regarding the DRI™ Ecstasy Plus Assay. This is a medical device for in-vitro diagnostics, specifically a homogeneous enzyme immunoassay for detecting ecstasy drugs in human urine. The document mainly focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance characteristics and states the acceptance criteria (stated as "met the acceptance criteria" or specific percentage/range values).

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

The document does not explicitly state the sample size used for the test set. It mentions "Negative sample agreement" and "Positive sample agreement" in the method comparison and "structurally unrelated compounds were spiked into negative pool urine at the tested concentrations" for specificity, but no specific numbers of samples are provided.

The data provenance is also not stated. It does not specify the country of origin of the data or whether the studies were retrospective or prospective.

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

For this type of in-vitro diagnostic device (immunoassay for drug detection), the ground truth is typically established by alternative chemical methods (e.g., GC/MS or LC-MS/MS), not by expert human readers. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of clinical image review is not applicable here. The document states: "A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography with tandem mass spectrometry (LC-MS/MS) is the preferred confirmatory method."

4. Adjudication Method for the Test Set

Since the ground truth is established by alternative chemical methods like GC/MS or LC-MS/MS, an adjudication method for reconciling expert opinions is not applicable. The result from the confirmatory chemical method serves as the definitive ground truth.

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. This device is an in-vitro diagnostic immunoassay, not an AI-powered diagnostic tool requiring human interpretation or a multi-reader multi-case study. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant to this submission.

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

Yes, in a sense. The "performance testing" described (Precision, Method Comparison, Specificity, Interference, Stability) represents the standalone performance of the assay itself. The immunoassay provides a direct analytical result (qualitative or semi-quantitative) without human interpretation affecting the primary outcome of detection. The device's output is an objective measurement (e.g., optical density change leading to a positive/negative determination), rather than an image requiring human interpretation.

7. The Type of Ground Truth Used

The type of ground truth used is confirmatory analytical methods, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography with Tandem Mass Spectrometry (LC-MS/MS). This is explicitly stated as the "preferred confirmatory method" to obtain a "confirmed analytical result."

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. Immunoassays are typically developed and validated using a series of laboratory experiments with known samples (spiked urine, controls, clinical samples confirmed by reference methods) rather than being "trained" on a dataset in the way an AI algorithm is. The development process would involve optimizing reagents and assay conditions but doesn't usually involve a "training set" in the machine learning context.

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

As there is no mention of a "training set" in the context of an immunoassay, the establishment of its ground truth is not applicable as outlined for AI/ML devices. The "ground truth" for developing and validating such an assay would be established by preparing samples with known concentrations of the target analytes and confirming those concentrations using gold-standard analytical techniques like GC/MS or LC-MS/MS.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Here's an breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

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

Precision Studies (Laboratory Testing):

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

Comparison Studies (Clinical Samples):

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

Lay User Study:

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

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

Precision Studies and Lay User Studies:

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

Comparison Studies (Clinical Samples):

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

4. Adjudication Method for the Test Set

Precision Studies and Lay User Studies:

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

Comparison Studies (Clinical Samples):

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

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

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

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

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

7. The Type of Ground Truth Used

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

8. The Sample Size for the Training Set

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

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

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

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Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are lateral flow chromatographic immunoassays designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

Test Barbiturates (BAR) Benzodiazepines (BZO) Amphetamine (AMP) Methadone (MTD) Oxycodone (OXY) Phencyclidine (PCP)

• Calibrator Secobarbital Oxazepam D-Amphetamine Methadone Oxycodone Phencyclidine
  Cut-off level 300 ng/mL 300 ng/mL 1000 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL

The tests contain two formats: 1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above. These tests are intended for in vitro diagnostics use. They are intended for prescription use.

The assays provide only a preliminary analytical test 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.

Xenta Drug Screen Cup and Xenta Drug Screen Dipcard are competitive binding, lateral flow immunochromatographic assays for the qualitative detection of Barbiturate, Benzodiazepine, Amphetamine, Methadone, Oxycodone, Phencyclidine at or above the cut-off levels as indicated. The tests are performed without the use of an instrument.

The test cup and test dipcard formats use identical test strips made with the same chemical formulation and manufacturing procedures.

The provided document describes the performance of the Xenta Drug Screen Cup and Xenta Drug Screen Dipcard for detecting various drugs in human urine. The study evaluates cross-reactivity, interference, effect of pH and specific gravity, precision, and accuracy.

Here's an breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

The document does not explicitly state "acceptance criteria" but rather presents a rigorous set of performance data that would generally be used to support claims of substantial equivalence. For immunoassays of this type, key performance indicators are typically precision (agreement at different concentrations, especially near the cutoff) and accuracy (agreement with a gold-standard confirmatory method like GC/MS).

Implicit Acceptance Criteria (based on common standards for such devices):

• Precision: High percentage of agreement (positive/negative results) for samples spiked at various concentrations, especially those near the cutoff (e.g., -25% and +25% of cutoff). For negative and very high positive concentrations, 100% agreement would generally be expected.
• Accuracy: High concordance with a confirmatory method (GC/MS) for clinical samples, particularly for drug-free, high positive, and discordant samples.
• Specificity (Cross-reactivity): Low or no cross-reactivity with structurally similar compounds and other common substances, or clearly defined cross-reactivity profiles.
• Robustness (Interference, pH, Specific Gravity): The device's performance should not be significantly affected by common interfering substances, varying urine pH, or specific gravity within physiological and expected ranges.

Reported Device Performance:

The document provides extensive data demonstrating the device's performance across these parameters. For brevity, here's a summary derived from the tables provided in section 8:

Note: Agreement is nearly 100% for samples significantly below (-75%, -50% cutoff) and significantly above (+50%, +75%, +100% cutoff) the cutoff. |
| Accuracy (Concordance with GC/MS) | For all drugs (AMP, BAR, BZO, MTD, OXY, PCP) and both device formats (Single/Multi Drug Test Cup and Dipcard), the device consistently showed:

• 0 false positives in drug-free samples.
• 0 false positives in samples less than half the cutoff.
• Very few false positives (0-1) and some false negatives (4-8) in the "Near Cutoff Negative" (between 50% below cutoff and cutoff concentration) category.
• Very few false positives (0) and some false negatives/positives (range varies, but generally consistent with expected +/- 25% cutoff performance) in the "Near Cutoff Positive" (between cutoff and 50% above cutoff concentration) category.
• 0 false negatives in "High Positive" samples (greater than 50% above the cutoff).
  Specific discordant results are minimal and generally at concentrations very close to the cutoff.
  In total, for each drug, 80 clinical samples were tested, with very high overall agreement for clearly negative or clearly positive samples. |
  | Cross-reactivity | Detailed tables show the lowest concentration of various related compounds that produced a positive result. Percent cross-reactivity is calculated. E.g., L-Amphetamine: 2%, MDA: 50%, Hydrocodone: 3.3%. This is a comprehensive evaluation common for immunoassays. |
  | Interference | "None of the compounds listed below were shown to interfere." (List includes numerous common medications and physiological substances at 100 µg/mL). |
  | Effect of pH | "The results demonstrate that varying ranges of pH do not interfere with the performance of the test." (Tested pH range 3-9). |
  | Effect of Specific Gravity | "The results demonstrate that varying ranges of urinary specific gravity do not affect the test result." (Tested SG 1.002 to 1.040). |
  | Stability of Test Line | "The results show that the color T line... are stable from 3 to 50 minutes." (Suggested read time: 5 to 30 minutes). |

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

• Precision Test Set Sample Size:
  • For each drug, for both single and multi-drug formats, and for both Test Cup and Test Dipcard:
    • 9 concentrations (0, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100% of cutoff).
    • 60 determinations per lot for each concentration (this is derived from 3 aliquots x 3 runs/day x 10 days x 2 operators/device type at each of the 3 sites, meaning 60 samples per lot, per concentration for each device type).
    • Tested with 3 lots.
    • Total precision observations for one drug and one device format (e.g., AMP on Single Test Cup) = 9 concentrations x 60 determinations/lot x 3 lots = 1620 observations.
    • Total observations for all 6 drugs and 2 device types (Single Test Cup, Multi Test Cup, Single Test Dipcard, Multi Test Dipcard) multiplied by 1620 observations per format.
• Accuracy Test Set Sample Size:
  • 80 clinical urine samples per drug (AMP, BAR, BZO, MTD, OXY, PCP) for each of the four device variants (Single Drug Test Cup, Multi Drug Test Cup, Single Drug Test Dipcard, Multi Drug Test Dipcard).
  • Total accuracy samples = 80 samples/drug x 6 drugs = 480 clinical samples (with GC/MS confirmation). These 480 samples are then tested across the 4 device variants.
• Data Provenance:
  • Clinical Urine Samples: "80 clinical urine samples collected all from sample place several hospitals and drug relief reformatory."
  • Retrospective/Prospective: The description does not explicitly state retrospective or prospective collection for the clinical samples. However, given they were "collected all from sample place," it implies they were likely existing samples (retrospective) or collected for the specific purpose of the study (prospective), but the exact method isn't specified. The emphasis on blind labeling and randomization for testing suggests a controlled prospective-like application in the study even if samples were retrospectively sourced.
  • Country of Origin: Not explicitly stated for specific samples, but the submitting company is "Xenta Biomedical Science Co., Ltd." located in Guangzhou, China.

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

• The ground truth for the clinical accuracy test set was established by Gas Chromatography/Mass spectrometry (GC/MS). GC/MS is considered the "preferred confirmatory method" and the gold standard for drug detection in urine.
• No human "experts" (e.g., radiologists) were used to establish the ground truth in this context; instead, a highly accurate analytical laboratory method (GC/MS) served as the gold standard. Therefore, the concept of "qualifications of those experts" does not directly apply in the way it would for image-based diagnostic devices. The expertise lies in the laboratory personnel performing and interpreting the GC/MS analysis.

4. Adjudication Method for the Test Set

• GC/MS was used as the confirmatory method to adjudicate the results of the rapid tests.
• For the precision study, samples were "blindly labeled by a nonparticipant" and "randomized prior to testing," indicating a blind comparison against the known spiked concentrations.
• For the accuracy study, clinical samples were also "blindly labeled by a nonparticipant" and "randomized prior to testing" against the GC/MS confirmed results.
• There's no mention of a traditional group adjudication method (e.g., 2+1, 3+1) involving multiple human readers of the rapid test, as the rapid test is interpreted visually by a single operator. Discordant results were analyzed by comparing the device result directly against the GC/MS result and the drug concentration.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not performed, nor would it be applicable for this type of device.
• This device is a qualitative lateral flow immunoassay for drug detection in urine, designed for visual interpretation. It is not an AI-assisted diagnostic imaging device for human interpretation like those typically evaluated in MRMC studies. Therefore, there's no AI component or human reader improvement analysis.

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

• Yes, in essence. The device itself is a "standalone" test in the sense that its performance (how accurately it detects drugs based on chemical reactions) is tested directly against gold standard methods (GC/MS) or known spiked concentrations.
• The interpretation step is visual, performed by a human operator, but the core performance data (cross-reactivity, precision, accuracy) reflect the inherent capability of the immunoassay itself to produce a detectable signal at certain concentrations. The studies described are primarily focused on this standalone performance of the test strip.

7. The Type of Ground Truth Used

• Laboratory Confirmatory Method (GC/MS): This was the primary gold standard ground truth for the clinical accuracy studies.
• Known Spiked Concentrations: For the precision studies, the ground truth was established by spiking drug-free urine with precisely measured concentrations of analytes, confirmed by GC/MS. This allows for a very controlled evaluation of the device's consistency and ability to detect at specific thresholds.

8. The Sample Size for the Training Set

• The document describes performance studies for the device, implying a final validation of a developed product. It does not mention a "training set" in the context of an algorithm or machine learning model.
• For a traditional immunoassay, there isn't a "training set" in the computational sense. The "training" for such a device involves the biochemical development and optimization of the reagents and test strip design. The provided data are for verification and validation of the final product.

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

• As there is no "training set" in the context of an AI/machine learning algorithm, this question is not applicable. The development of an immunoassay involves optimizing antibody-antigen reactions and signal generation, which is a biochemical engineering process, not a data-driven model training process.

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The Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

This FDA 510(k) summary describes modifications to an existing device, and therefore, many of the standard performance characteristics were "Not applicable" as they were assessed in the original submission (K182719). The primary assessment here is for analytical specificity for four additional compounds.

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

1. Table of Acceptance Criteria and Reported Device Performance

The "acceptance criteria" for the analytical specificity in this submission aren't explicitly stated as numerical targets in the same way clinical performance metrics would be. Instead, the study's purpose was to demonstrate cross-reactivity for the additional compounds. The "reported device performance" is the measured cross-reactivity percentage.

Note on Acceptance Criteria: For analytical specificity (cross-reactivity), the "acceptance" is typically that the manufacturer characterizes the cross-reactivity of relevant compounds. There isn't usually a strict numerical threshold for what percentage is "acceptable" as it depends on the clinical context and the compound. The goal is to inform users of potential interferences. In this case, the acceptance is implied by the FDA's clearance, indicating that the characterized cross-reactivity does not negatively impact substantial equivalence to the predicate device.

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

• Sample Size: The document does not explicitly state the specific number of test samples (e.g., individual spiked urine samples) used for each cross-reactivity compound. It only lists the compounds and their cross-reactivity percentages.
• Data Provenance: Not specified in this document. Assumed to be experimental data generated by the manufacturer (Quidel Cardiovascular Inc.) in a lab setting. The country of origin is not mentioned, and it is a prospective lab study to characterize the device.

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

Not applicable for this type of analytical specificity study. The ground truth (the presence and concentration of the spiked compounds) is established by the controlled experimental setup and precise chemical preparation, not by expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is an analytical study, not one requiring expert adjudication of clinical or imaging data.

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

No, an MRMC comparative effectiveness study was not done. This device is a qualitative in vitro diagnostic assay, not an imaging or interpretive AI device that would typically involve human readers.

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

Yes, a standalone performance study was implicitly done in the sense that the device (Quidel Triage® TOX Drug Screen, 94600 with the Triage® MeterPro) determines the presence of drugs based on its internal algorithms (competitive immunoassay followed by fluorescence detection and threshold comparison). The reported cross-reactivity percentages are a measure of its standalone analytical performance. No "human-in-the-loop" is involved in the determination of a positive/negative result by the MeterPro.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this analytical specificity study was analytical spiking and known concentration. The compounds were experimentally prepared at known concentrations in a matrix (likely drug-free human urine) and then tested with the device. The "Results Positive at (ng/mL)" column indicates the lowest concentration at which the device reported a positive result for that compound.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that would require a "training set" in the traditional sense of computational models. The device's underlying immunoassay technology relies on specific antibody-antigen binding, not trained algorithms.

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

Not applicable, as there is no "training set" for this immunoassay device.

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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 Quidel Triage® TOX Drug Screen, 94600 is a fluorescence immunoassay to be used with the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine of up to 9 drug assays at or above the threshold concentrations. The threshold concentrations are provided below:

This test provides only a preliminary test result. Clinical consideration and professional judgment must be applied to any drug test result, particularly in evaluating a preliminary positive result. A more specific alternate chemical must be used to obtain a confirmed analytical result. Gas Chromatography / Mass Spectroscopy (GC/MS), Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods.

Quidel Triage® MeterPro:

The Quidel Triage® MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage® MeterPro can be used in a laboratory or in a point-of-care setting.

Quidel Triage® TOX Drug Screen, 94600:

The Quidel Triage® TOX Drug Screen, 94600 is a single use test device and is used in conjunction with the Quidel Triage® MeterPro. The device contains murine monoclonal antibody conjugates and drug conjugates labeled with a fluorescent dye or immobilized on the solid phase and stabilizers. The testing device is inserted into and read by the Quidel Triage® MeterPro. Threshold concentrations are used to separate a negative result from a presumptive positive result.

Quidel Triage® MeterPro:

The Quidel Triage MeterPro is a portable fluorescence instrument used to measure the results of tests manufactured by Quidel Cardiovascular Inc. The Quidel Triage MeterPro can be used in a laboratory or in a point-of-care setting.

The Quidel Triage MeterPro uses a laser as a light source. Light from the laser hits a test device that has been inserted in the meter. This causes the fluorescent dye in the test device to give off energy. The more energy the fluorescent dye gives off, the stronger the signal.

The provided document describes the Quidel Triage® TOX Drug Screen, 94600 and the Quidel Triage® MeterPro for the qualitative determination of the presence of drugs and/or metabolites in human urine. The acceptance criteria and the study results are detailed in the "Performance Characteristics" section (1.13) and "Comparison studies" section (1.13.2.a).

Here's a breakdown of the requested information:

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

The acceptance criteria for each analyte are based on the percentage of positive and negative results at concentrations around the cutoff, as shown in the "Precision/Reproducibility" data in section 1.13.1.a and "Assay cut-off" in section 1.13.1.f. The primary performance metric from the method comparison study (1.13.2.a) is the agreement between the Quidel Triage TOX Drug Screen, 94600 and GC/MS or LC-MS/MS values, particularly for specimens near the threshold and outside the threshold.

Below is a summary table, combining data from the precision/reproducibility testing (1.13.1.a) and the method comparison study (1.13.2.a). For the precision/reproducibility, a high percentage of correct results (e.g., all negative below -75% of cutoff, all positive above +50% of cutoff) would be considered acceptance. For method comparison, "agreement" is implicitly the acceptance criteria, with discordant results requiring explanation.

• 126 ng/mL (-75%): 720/720 Neg (100%)
• 760 ng/mL (+50%): 720/720 Pos (100%)
• 522 ng/mL (Cutoff): 50 Neg/669 Pos (89.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 2 Neg/98 Pos (98% Pos)
  (Discordant results acknowledged and explained related to isomeric cross-reactivity.) |
  | mAMP (500 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 250 ng/mL (-50%): 720/720 Neg (100%)
• 742 ng/mL (+50%): 720/720 Pos (100%)
• 529 ng/mL (Cutoff): 281 Neg/431 Pos (60.0% Pos) | Out of 218 samples:
• Negative (150% of threshold): 7 Neg/91 Pos (92.9% Pos)
  (Discordant results acknowledged, with some attributed to isomeric differences in cross-reactivity.) |
  | BAR (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 53 ng/mL (-75%): 736/736 Neg (100%)
• 306 ng/mL (+50%): 719/719 Pos (100%)
• 192 ng/mL (Cutoff): 111 Neg/605 Pos (84.5% Pos) | Out of 218 samples:
• Negative (150% of threshold): 0 Neg/97 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | BZO (200 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 58 ng/mL (-75%): 704/704 Neg (100%)
• 306 ng/mL (+50%): 720/720 Pos (100%)
• 219 ng/mL (Cutoff): 318 Neg/402 Pos (55.9% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | COC (150 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 76 ng/mL (-50%): 719/719 Neg (100%)
• 218 ng/mL (+50%): 736/736 Pos (100%)
• 157 ng/mL (Cutoff): 26 Neg/694 Pos (96.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | EDDP (100 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 29 ng/mL (-75%): 720/720 Neg (100%)
• 143 ng/mL (+50%): 716/716 Pos (100%)
• 111 ng/mL (Cutoff): 126 Neg/594 Pos (82.5% Pos) | Out of 220 samples:
• Negative (150% of threshold): 0 Neg/98 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | OPI (300 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 165 ng/mL (-50%): 722/722 Neg (100%)
• 480 ng/mL (+50%): 720/720 Pos (100%)
• 344 ng/mL (Cutoff): 197 Neg/507 Pos (72.0% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/98 Pos (99.0% Pos)
  (Some discordant results explained by secondary reference testing.) |
  | THC (50 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 12 ng/mL (-75%): 716/716 Neg (100%)
• 78 ng/mL (+50%): 4 Neg/700 Pos (99.4% Pos)
• 54 ng/mL (Cutoff): 163 Neg/559 Pos (77.4% Pos) | Out of 221 samples:
• Negative (150% of threshold): 0 Neg/99 Pos (100% Pos)
  (Discordant results acknowledged and explained.) |
  | TCA (1000 ng/mL) | At -75% and below: 100% Neg; At +50% and above: 100% Pos | - Neg Control (0%): 720/720 Neg (100%)
• 498 ng/mL (-50%): 719/719 Neg (100%)
• 1577 ng/mL (+50%): 1 Neg/719 Pos (99.9% Pos)
• 996 ng/mL (Cutoff): 218 Neg/518 Pos (70.4% Pos) | Out of 220 samples:
• Negative (150% of threshold): 1 Neg/95 Pos (99% Pos)
  (Some discordant results explained by data entry errors or pH interference.) |

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

• Precision/Reproducibility Test Set:
  • For each of the 9 analytes, 720-736 samples were tested for each concentration point (0 to +100% of cutoff, plus negative control). This means for each analyte, n=720-736 replicates were performed at each concentration.
  • Data provenance: Not explicitly stated, but the submission is for the FDA in the US. The study involved "three (3) study sites" which implies data collection within a controlled, prospective study setting, most likely in the US, given the FDA submission. The samples were "blinded and randomized" prior to testing.
• Method Comparison Test Set:
  • The total number of samples for each analyte in the method comparison study with GC/MS or LC-MS/MS varies slightly per analyte but is around 220 samples (e.g., for AMP, 99+11+2+98+0+0+8 = 218 specimens + 2 discordant cases).
  • Data provenance: The samples were described as "unaltered urine specimens," implying they were clinical samples. The document does not explicitly state the country of origin or whether the data was retrospective or prospective. However, the use of "patient specimens" strongly suggests prospective collection for the purpose of the study.

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

• For the Precision/Reproducibility study, the ground truth was established by the prepared concentrations of the analytes (e.g., negative control, 25%, 50%, 75%, cutoff, 125%, 150%, 175%, and 200% of cutoff). This does not involve human experts establishing ground truth for individual samples, but rather analytical controls.
• For the Method Comparison study, the ground truth was established by a "reference method," specifically GC/MS or LC-MS/MS values. These are analytical methods considered the gold standard for drug confirmation and quantification. This does not involve human experts establishing ground truth for each case, but rather the laboratory performing these reference methods. No specific number or qualifications of experts operating these reference instruments are mentioned, as the results of these instruments are considered the objective ground truth.

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

• For the Precision/Reproducibility study, no adjudication method is explicitly described as the results are based on measured values against known concentrations.
• For the Method Comparison study, particularly for discordant results between the device and the reference method, an adjudication process did occur. In some cases, explanations are provided for the discordance (e.g., isomeric cross-reactivity for AMP and mAMP, the presence of multiple metabolites for BZO and OPI, pH interference for TCA, or data entry errors). For OPI, one discordant case (Specimen ID 572644) was sent to a "second reference testing laboratory" for reconfirmation, which then aligned with the device's negative result. This indicates a form of secondary confirmation/adjudication by an additional reference lab for specific discordant cases, rather than a typical 2+1 or 3+1 expert consensus model for image/clinical interpretation.

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 document describes an in vitro diagnostic (IVD) device that performs qualitative drug screening using a fluorescence immunoassay and a meter (Quidel Triage® MeterPro). It is not an AI-assisted diagnostic device, nor does it involve human readers interpreting images or clinical data. Therefore, an MRMC comparative effectiveness study involving human readers with and without AI assistance is not applicable to this device.

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

• The Quidel Triage® TOX Drug Screen, 94600 with the Quidel Triage® MeterPro functions as a standalone device in terms of producing a "POS" or "NEG" result for each drug assay. The meter reads the test device and provides a direct qualitative result. While the meter requires a human operator to insert the device and, if desired, print or transmit results, the interpretation of the fluorescence signal into a positive or negative drug screen result is entirely performed by the instrument's programming, which is equivalent to an "algorithm only" performance. The performance data presented in the precision/reproducibility and method comparison studies directly reflect this standalone performance.

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

• For the analytical performance studies (precision/reproducibility, analytical specificity, cutoff characterization), the ground truth was established by known prepared concentrations of drugs/metabolites or spiking experiments.
• For the method comparison study, the ground truth was established by Gas Chromatography / Mass Spectroscopy (GC/MS) or Liquid Chromatography / Mass Spectroscopy / Mass Spectroscopy (LC-MS/MS) values. These are analytical "gold standard" methods.

8. The sample size for the training set

• The document describes a 510(k) submission for a new IVD device and presents validation studies. It does not explicitly mention a "training set" in the context of machine learning or AI models. The studies are designed to demonstrate the analytical performance and substantial equivalence of the device to existing predicate devices. Therefore, a specific training set sample size is not applicable/not provided in this type of submission. The performance data is from a test/validation set.

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

• As a "training set" is not explicitly referenced in the context of AI/machine learning development, the method of establishing its ground truth is not applicable/not provided. The ground truth for the validation studies (test sets) was established via known concentrations of analytes and reference methods (GC/MS, LC-MS/MS) as detailed 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 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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The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the qualitative detection of amphetamines, barbiturates, benzodiazepines, cocaine, ecstasy, methadone, methamphetamine, opiates, oxycodone, phencyclidine, marijuana, tricyclic antidepressants (imipramine) and buprenorphine in urine at the cut-off concentrations listed below. Test for barbiturates, benzodiazepine, oxycodone, buprenorphine and tricyclic antidepressants (imipramine) cannot distinguish between abused drugs and certain prescription medications. The test is intended for professional use only.

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a screening test for the rapid detection of the following drugs in urine at the cut-off concentrations listed in Table 1. It is a competitive immunoassay that is used to screen for the presence of drugs of abuse in urine. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a single-use device utilizing a cup format.

The device is based upon the Phamatech At Home 12 Drug Test Models 9308Z cleared in K070009 for home use for the detection of amphetamines(AMP), barbiturates (BAR), benzodiazepines (BZD), cocaine (COC), ecstasy (MDMA), methadone (MTD), methamphetamine(MET), opiates (OPI), oxycodone (OXY), phencyclidine (PCP) and marijuana (THC) in urine samples. The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z adds testing for tricyclic antidepressants (TCA) (imipramine) and buprenorphine (BUP).

The QuickScreen Pro Multi-Drug Screening Test System is intended for use in prescription point-of-care settings.

The QuickScreen™ Pro Multi Drug Screening Test Model 9395Z is a chromatographic absorbent device in which drugs or drug metabolites in a urine sample compete with drug / protein conjugate immobilized on a porous membrane of the test device for a limited number of antibody / dye conjugate binding sites. The test device employs a unique combination of monoclonal and polyclonal antibodies to selectively identify drugs of abuse in urine. The test device also contains a self-timer that indicates when test results are ready to be interpreted.

Here's a breakdown of the acceptance criteria and study information for the QuickScreen Pro Multi Drug Screening Test, Model 9395Z, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" for the performance characteristics beyond the cut-off concentrations. Instead, it describes the established cut-off concentrations for each analyte and implies that the device's performance (sensitivity/precision) was evaluated against these cut-offs. The study focused on proving substantial equivalence to a predicate device, particularly for the newly added analytes (TCA and BUP).

Therefore, the "acceptance criteria" can be inferred to be the ability of the device to qualitatively detect the analytes in urine at or around the specified cut-off concentrations with acceptable precision/sensitivity. The "reported device performance" is a general statement that the device performs as intended and is substantially equivalent to the predicate for all analytes, with specific studies for TCA and BUP.

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

The document does not specify the exact sample sizes used for the test sets for each type of performance study (Method Comparison, Assay Interference, Assay Precision/Sensitivity, Prozone Response, Sample pH, Read Time, Sample Temperature, Specific Gravity).

Data provenance is not explicitly stated regarding country of origin; however, the manufacturer is Phamatech, Inc. in San Diego, CA, suggesting the studies were likely conducted in the US. The studies are prospective in nature, as they involve testing the device to demonstrate its performance.

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

The document does not mention the use of experts to establish ground truth for the test set. For a drug screening test, the ground truth is typically established by analytical methods (like GC/MS) or by spiking urine samples with known concentrations of analytes.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method by human readers for the test set. For a qualitative immunoassay, the result is read directly from the test lines (presence or absence), and the comparison is to the confirmed analytical result.

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 MRMC comparative effectiveness study was done, nor does the document describe any AI component to the device. This is a point-of-care, qualitative immunoassay designed for direct interpretation.

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

This device is not an algorithm-only device. It is a physical immunoassay kit that produces a visual result. The "standalone" performance would refer to the device itself providing a result that is then compared to an analytical standard, which is implied by the performance studies (e.g., precision/sensitivity). There are no "human-in-the-loop" aspects in terms of interpretation algorithms to evaluate.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this type of device is established by analytical methods, specifically by preparing urine samples with known concentrations of the analytes (e.g., using fortified samples at various concentrations around the cut-off) and comparing the device's results to these known concentrations, or by confirming positive results with a gold standard like Gas Chromatography/Mass Spectrometry (GC/MS). The document states, "Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method," indicating this is the expected ground truth for confirmation.

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This is common for immunoassay devices, where performance is typically established through analytical validation studies rather than machine learning training.

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

Since no training set is described for a machine learning algorithm, the concept of establishing ground truth for a training set does not apply here. The device's performance is validated against analytical standards and comparative methods.

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The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone. These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 obtained.

The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone. These assays may yield positive results when barbiturates, benzodiazenines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry 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 obtained.

These devices are one-step lateral flow chromatographic immunoassays consisting of any combination of one (1) to thirteen (13) individual test strip(s). Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.

Here's an analysis of the acceptance criteria and study detailed in the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two types of performance studies: a "precision" study (analytical performance) and a "lay user study" (user performance for OTC use). The acceptance criteria for the precision study appear to be implicit in the results, suggesting that all negative samples below a certain threshold should be negative, and all positive samples above a certain threshold should be positive. For the lay user study, the acceptance criteria are for the interpretation of results by the lay users, implicitly aiming for high agreement with the expected result.

Analytical Performance (Precision Study - Example for Amphetamines)

Lay User Study Performance (Example for Amphetamines)

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

• Analytical/Precision Study Test Set:

  • For each of the 13 analytes, there were 9 different concentration levels tested.
  • For each concentration level, 50 samples were tested per Lot (Neg/Pos).
  • There were 3 Lots, for a total of 150 tests per concentration level per analyte.
  • Total tests per analyte: 9 concentrations * 50 samples/conc/lot * 3 lots = 1350 tests.
  • Total tests across all 13 analytes: 1350 tests/analyte * 13 analytes = 17,550 tests.
  • Data Provenance: Not explicitly stated, but typically these types of precision studies are conducted in a controlled laboratory setting (e.g., by the manufacturer). It is a retrospective analysis of device performance under controlled conditions.

• Lay User Study Test Set:

  • For each analyte, various concentrations at 0%, 75%, 125%, and 150% of the cutoff were tested.
  • The number of samples varied per concentration level per analyte. For example, for Amphetamines, there were 350 samples at 0%, 10 at 75%, 10 at 125%, and 30 at 150%. This totals 400 samples for Amphetamines.
  • Since there were 13 analytes, this would suggest a very large number of total tests if each participant tested all analytes. However, the text states "each participant was provided one (1) package insert, one (1) blind labeled test solution, and one (1) test device. Test solutions were randomly picked for participants, one for each." This implies each participant (total 400) tested one specific drug concentration. Therefore, the overall sample size for the lay user study is 400 participants/tests.
  • Data Provenance: The study was conducted with 400 human participants with "diverse educational backgrounds and ranged in age from 18 to >60." This is prospective data collection with human subjects. The country of origin is not explicitly stated, but given it's an FDA submission, it's typically in the US or in a country following similar regulatory standards.

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

• Analytical/Precision Study: The ground truth for the test concentrations (e.g., 0 ng/mL, 250 ng/mL, cutoff, etc.) is established by laboratory standards and precise dilution methods, not by human experts. The concentrations were precisely prepared.
• Lay User Study: Similar to the analytical study, the ground truth for these samples was based on the known, prepared concentrations of the drug within the test solutions. No human experts were used to establish the ground truth; it was based on the controlled spiking of urine samples.

4. Adjudication Method for the Test Set

• Analytical/Precision Study: No adjudication method involving multiple readers is mentioned. The results were recorded as Neg/Pos based on the device's output and presumably read by the operators performing the tests.
• Lay User Study: No formal adjudication method is mentioned. Each participant performed one test and reported their result. The study assessed how well the individual lay users interpreted the result, rather than having multiple readers interpret the same result for adjudication.

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

• No MRMC comparative effectiveness study was done. This device is a rapid, qualitative immunoassay for drug detection, and the studies performed focus on its analytical performance and lay user interpretability, not on reader improvement with AI assistance. The device itself is not an AI-assisted diagnostic tool for human readers.

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

• This device is not an AI algorithm. It is a chemical immunoassay device. The results are visually read by a human. Therefore, a "standalone" algorithmic performance study without human-in-the-loop is not applicable in the context of AI. However, the "precision study" can be considered a standalone performance assessment of the device's chemical reactions, irrespective of user interpretation (though a human still reads the lines).

7. Type of Ground Truth Used

• Analytical/Precision Study: The ground truth was based on known, precisely prepared drug concentrations in the urine matrix. This is a form of "spiked" samples, where the true concentration is known by the experimenters.
• Lay User Study: The ground truth was also based on known, precisely prepared drug concentrations in the test solutions given to participants.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a training set. It is a chemical immunoassay. Therefore, the concept of a "training set" is not applicable.

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

• Not applicable, as there is no training set for this type of device.

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