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TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drug or drug metabolite in urine at or above the stated cutoff concentrations:

Cutoff Concentrations:

• Amphetamines: 1000 ng/mL
• Benzodiazepines: 200 ng/mL
• Cocaine metabolite: 300 ng/mL
• Methamphetamine: 500 ng/mL
• Methamphetamine: 300 ng/mL
• Morphine: 300 ng/mL
• Morphine (M2K): 2000 ng/mL
• Phencyclidine (PCP): 25 ng/mL
• Tetrahydrocannabinols: 50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use in the qualitative detection of amphetamines (d,1-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), and methamphetamine (d-methamphetamine 300 ng/mL), morphine (morphine 300 ng/mL), and morphine (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL) and THC (11-nor-Δ'-THC-9-carboxylic acid 50 ng/mL).

The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.

Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrance. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative") result is the absence of a blue band.

An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

I am sorry, but I am unable to extract the detailed information requested regarding the acceptance criteria and the study that proves the device meets the acceptance criteria from the provided text. The document is a 510(k) summary for a medical device (drug test cups) and primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific acceptance criteria and performance study results.

The document states the intended use and cutoff concentrations for various drugs, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for a test set.
• Information on experts used for ground truth, adjudication methods, or specific expert qualifications.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of AI assistance.
• Results of a standalone algorithm performance study.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The text mentions that the assays are based on "microparticle capture inhibition" and describes the general principle of how the test works (formation/absence of a blue band). It also states that the modified devices "have the same intended use and incorporate the same fundamental scientific technology as the predicate devices."

To provide the requested information, a different type of document, such as a detailed study report or clinical trial summary, would be necessary.

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The OnTrak TesTcard menus are various combinations of the different drugs hat are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Amphetamines (d,l-amphetamine): 1000 ng/mL, Barbiturates (secobarbital): 200 ng/mL, Benzodiazepines (oxazepam): 100 ng/mL, Cocaine metabolite (benzoylecgonine): 300 ng/mL, Methamphetamine (d-methamphetamine): 500 ng/mL, Morphine (morphine): 300 ng/mL, PCP (phencyclidine): 25 ng/mL, Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL, THC (11-nor-delta9-THC-9-carboxylic acid): 50 ng/mL. AND/OR TesTcard products provide only preliminary analytical test result. A more specific alternate test method must be used in order to obtain a confirmed analytical result. Prescription Use V (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

The OnTrak TesTcard assays contained in this submission are in vitro diagnostic tests intended for the qualitative detection of drug or drug metabolite in urine. The TesTcard devices simultaneously test for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of amphetamines (d,l-amphetamine 1000 ng/mL), barbiturates (secobarbital 200 ng/mL), benzodiazepines (oxazepam 100 (benzoylecgonine cocaine metabolite ng/mL). methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL), PCP (phencyclidine 25 ng/mL), tricyclic antidepressants (TCA) (imipramine 1000 ng/mL) and THC (11-nor-A-THC-9-carboxylic acid 50 ng/mL). The TesTcard assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber. When the TesTcard contacts the urine sample, the sample is absorbed into the TesTcard sample pad. The absorbed sample travels through the reagent strips contained in the device by capillary action. In the reagent strip, the sample rehydrates and mobilizes antibody-coated blue microparticles. The microparticle-urine suspension continues to migrate through the reagent strip and comes in contact with the immobilized drug conjugates. In the absence of drugs in the urine, the antibody coated microparticles bind to the drug conjugates and blue bands are formed in the result areas. When drugs are present in the specimen, they bind to the respective antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the appropriate drug conjugate and no blue band is formed in the result area below the drug name. A positive specimen causes the membrane to remain white. An additional antibody/antigen reaction occurs at the "VALID" area. The "TEST VALID" blue band forms when antibodies imbedded in the reagent membrane bind to the antigen on the blue microparticles. The presence of the "TEST VALID" band indicates that the test has completed, the reagents in the "TEST VALID" area are valid, and the results are ready to interpret.

The provided text describes a 510(k) premarket notification for the OnTrak TesTcard, a device for qualitative detection of drugs or drug metabolites in urine. However, it does not contain any information about a study proving the device meets specific acceptance criteria.

The document outlines the device's intended use, technological characteristics, and claims substantial equivalence to a predicate device, but it lacks detailed performance data, sample sizes for testing, ground truth establishment, or expert involvement.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or answer most of the other questions regarding a study, as this information is not present in the provided text.

Based on the information provided, here's what can be extracted:

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

• Not provided in the document. The document lists the cutoff concentrations for various drugs, which are essential for defining "positive" or "negative" results, but it does not present acceptance criteria (e.g., sensitivity, specificity thresholds) or actual performance data against these criteria.

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

• Not provided in the document.

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)

• Not provided in the document.

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

• Not provided in the document.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. This device is an in-vitro diagnostic test, not an AI-assisted diagnostic tool that would involve human "readers" in the context of radiology or similar fields.

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

• Not applicable/Not provided. This is an IVD device, not an algorithm, so "standalone" performance in the AI sense is not relevant. The device operates as a self-contained test.

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

• Not explicitly stated within the provided text. For qualitative drug detection tests like this, the ground truth for a study would typically be established by a reference method (e.g., Gas Chromatography/Mass Spectrometry - GC/MS) performed on the urine samples. The document only mentions that "A more specific alternate test method must be used in order to obtain a confirmed analytical result" which implies that such reference methods are for confirmation but doesn't detail their use in validation.

8. The sample size for the training set

• Not provided in the document. (This type of device does not typically have a "training set" in the machine learning sense.)

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

• Not provided in the document. (See above, not applicable in the ML sense.)

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On Trak TesTcard 9 product, is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. On Trak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites at or above the stated concentrations.
Cutoff Concentrations:
Amphetamines 1000 ng/mL
Barbiturates 200 ng/mL
Benzodiazepines 100 ng/mL
Cocaine metabolite 300 ng/mL
Methamphetamine 500 ng/mL
Morphine 300 ng/mL
Phencyclidine (PCP) 25 ng/mL
Tricyclic Antidepressants (TCA) 1000 ng/mL
Tetrahydrocannabinols (THC) 50 ng/mL

On Trak TesTcard 9 product 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 confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided document beyond the qualitative nature of the test. However, the device is intended for the "qualitative detection of drug or drug metabolites in urine" at or above specific cutoff concentrations. Therefore, the device would be expected to accurately identify the presence or absence of these substances at the given thresholds. The reported performance is not detailed in terms of sensitivity, specificity, or accuracy compared to the gold standard, but the statement about "preliminary analytical test result" and the recommendation for "Gas chromatography/ mass spectrometry (GC/MS) as the preferred confirmation method" implies that the device serves as a screening tool.

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

The document does not provide information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

The document does not provide information on the number of experts used or their qualifications for establishing ground truth.

4. Adjudication Method

The document does not provide information on the adjudication method used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or the effect size of human reader improvement with AI assistance. This type of study is generally not applicable to a qualitative diagnostic test like the On Trak TesTcard 9, which is designed for standalone analysis rather than human-AI collaboration.

6. Standalone Performance Study

The study described is inherently a standalone performance study. The device, On Trak TesTcard 9, is an "in vitro diagnostic test" intended for "qualitative detection," meaning it produces a result without human interpretation of complex outputs.

7. Type of Ground Truth Used

While not explicitly stated, the implication that "Gas chromatography/ mass spectrometry (GC/MS) is the preferred confirmation method" suggests that GC/MS is intended to be the gold standard or ground truth for confirming the results of the On Trak TesTcard 9.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for the training set.

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

The document does not provide information on how the ground truth for the training set was established. Given the nature of a rapid diagnostic test, the "training set" might refer to well-characterized samples with known concentrations of drug metabolites, likely confirmed by a highly accurate method like GC/MS.

Ask a specific question about this device

TesTcup II and CupKit products are in vitro diagnostics tests intended for professional use for the qualitative detection of drugs or drug metabolites in urine at or above the stated cutoff concentrations.

Cutoff Concentrations:
Amphetamines: 1000 ng/mL
Benzodiazepines: 200 ng/mL
Cocaine metabolite: 300 ng/mL
Methamphetamine: 500 ng/mL
Morphine: 300 ng/mL
Morphine (M2K): 2000 ng/mL
Phencyclidine (PCP): 25 ng/mL
Tetrahydrocannabinols (THC): 50 ng/mL

TesTcup II and CupKit products provide only a preliminary analytical test result. A more reliable analytical method must be used in order to obtain a confirmed analytical result.

The OnTrak TesTcup II and OnSite Cupkit assays contained in this submission are in vitro diagnostic tests intended for professional use for the qualitative detection of amphetamines (d,l-amphetamine 1000 ng/mL), benzodiazepines (oxazepam 200 ng/mL), cocaine metabolite (benzoylecgonine 300 ng/mL), methamphetamine (d-methamphetamine 500 ng/mL), morphine (morphine 300 ng/mL) and morphine 2000 (morphine 2000 ng/mL), PCP (phencyclidine 25 ng/mL), and THC (11-nor-Δ 9 -THC-9-carboxylic acid 50 ng/mL).

The assays are based on the principle of microparticle capture inhibition. The test relies on the competition between drug, which may be present in the urine being tested, and drug conjugate immobilized on a membrane in the test chamber.

Urine is collected directly in the test cup provided. The drug profile card is placed in the samples by inserting it into the lid holder, then securing the lid onto the cup. Urine is drawn in the profile card by capillary action and reacts with antibody-coated microparticles and drug conjugate present on the membrane. In the absence of drug, the antibody is free to interact with the drug conjugate, causing the formation of a blue band.

When drug is present in the specimen, it binds to the antibody-coated microparticles. If sufficient drug is present, the microparticles are inhibited from binding the drug conjugate and no blue band is formed at the result window. A preliminary positive ("non-negative" result is the absence of a blue band).

An additional antibody/antigen reaction occurs at the "VALID" area. The "VALID" blue band forms when antibodies, which are imbedded in the reagent membrane, interact with and bind to the antigen on the blue microparticles.

This document describes the validation of the OnTrak TesTcup® II and OnSite CupKit™ for the qualitative detection of various drugs and drug metabolites in urine.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Precision" study are implicitly stated as:

• Greater than 95% confidence level that negative results will be attained with drugs at 25% (1/4 X) of their respective cutoff concentrations.
• Greater than 95% confidence level that positive results will be attained with drugs at 150% (1/2 X, presumably meant to be 1.5X) of their respective cutoff concentrations.

The "Accuracy" section compares the device results to GC/MS, and the "Comparison with predicate device" section compares it to existing devices. Rather than explicit acceptance criteria, these sections present overall percent agreement, indicating that a high level of agreement (e.g., typically >95%) is desired for clinical performance.

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

Precision Study:

• Sample Size: 63 replicates were tested for each scenario (drug, concentration, lot). Since there were 6 concentration levels, 2 lots, and 8 drugs/metabolites, this means a total of (63 replicates * 6 concentrations * 2 lots * 8 drugs) = 6048 individual tests for precision.
• Data Provenance: The specimens were "contrived specimens containing drugs or drug metabolites at various concentrations." The drugs/metabolites were spiked into "negative human urine pool." This indicates a prospective study using artificially prepared samples. Country of origin is not specified, but typically studies for US FDA PMA/510k are conducted within the US or under comparable standards.

Accuracy Study (Clinical Specimens):

• Sample Size (for comparison with GC/MS):
  • THC: 100 Negative, 13 (75-100% cutoff), 6 (100-125% cutoff), 31 (>125% cutoff) = 150 samples.
  • Cocaine: 100 Negative, 6 (75-100% cutoff), 7 (100-125% cutoff), 35 (>125% cutoff) = 148 samples.
  • PCP: 100 Negative, 8 (75-100% cutoff), unknown (100-125% cutoff, implied range for 0 positive), 37 (>125% cutoff) = 145+ samples (the 100-125% is zero positive, not clear if cases were tested in that range)
  • Amphetamine: 100 Negative, 8 (75-100% cutoff), 0 (100-125% cutoff), 29+2 (false negative) (>125% cutoff) = 139 samples.
  • Methamphetamine: 100 Negative, 2 (75-100% cutoff), 0 (100-125% cutoff), 48 (>125% cutoff) = 150 samples.
  • Morphine (300 ng/ml): 100 Negative, 0 (75-100% cutoff), 0 (100-125% cutoff), 46 (>125% cutoff) = 146 samples.
  • Morphine (2000 ng/ml): 100 Negative, 3 (75-100% cutoff), 0 (100-125% cutoff), 35 (>125% cutoff) = 138 samples.
  • Benzodiazepines: 100 Negative, 0 (75-100% cutoff), 0 (100-125% cutoff), 50 (>125% cutoff) = 150 samples.
• Data Provenance: "Clinical specimens." The study was evaluated in a "SAMHSA certified laboratory." "Clinical negative samples were screened negative by an automated immunoassay and reported as negative according to SAMHSA guidelines. Clinical specimens screened positive by an automated immunoassay." Some samples were diluted. This indicates retrospective clinical samples, likely obtained from a bank or collected as part of routine testing, then characterized further for the study.

Comparison with Predicate Device:

• Sample Size:
  • THC: 147 samples (47+3+0+100)
  • Cocaine: 150 samples (48+0+0+102)
  • PCP: 150 samples (41+1+0+108)
  • Amphetamines: 150 samples (36+4+0+110)
  • Methamphetamine: 158 samples (56+0+0+102)
  • Morphine (300 ng/ml): 161 samples (61+0+0+100)
  • Morphine (M2K): 150 samples (41+6+0+103)
  • Benzodiazepines: 164 samples (64+0+0+100)
• Data Provenance: "All of the above clinical specimens" were used, referring to the same clinical specimens as for the GC/MS comparison. This implies retrospective clinical samples.

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

Precision Study: The ground truth was established by spiking known concentrations of drugs/metabolites into negative human urine. This is a controlled experimental setup, not relying on expert interpretation for ground truth.
Accuracy Study (Clinical Specimens): The ground truth was established using GC/MS (Gas Chromatography/Mass Spectrometry), which is the gold standard for confirmatory drug testing. No human experts are explicitly mentioned as establishing the ground truth for these quantitative results. The interpretation of the device's qualitative results is then compared to the GC/MS quantitative results against the defined cutoffs.

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

There is no indication of an adjudication method in the traditional sense (e.g., for image interpretation needing multiple readers). The device produces a qualitative positive/negative result, which is then compared against quantitative GC/MS results or predicate device results. For the precision study, 3 operators tested replicates, but this was to assess reproducibility, not to adjudicate an uncertain "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

This document describes an in vitro diagnostic device, a rapid urine drug screen. It is not an AI-assisted diagnostic tool that involves human readers or interpreters in the way an MRMC study would typically evaluate (e.g., radiology interpretation). Therefore, no MRMC comparative effectiveness study was done, and the concept of "human readers improve with AI vs without AI assistance" is not applicable here. The device itself is the 'diagnostic tool' being evaluated.

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

Yes, this entire study is a standalone performance evaluation of the OnTrak TesTcup® II and OnSite CupKit™. The device provides a direct qualitative result (presence or absence of a blue band), and its performance is assessed against established quantitative methods (GC/MS) or predicate devices. There is no human intervention or interpretation of the immediate test result that would constitute a "human-in-the-loop performance" in the sense of an algorithm assist. The "operators" in the precision study are performing the test procedure, not interpreting ambiguous results.

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

• Precision Study: Known concentrations of spiked drugs/metabolites in negative human urine.
• Accuracy Study (Clinical Specimens): GC/MS (Gas Chromatography/Mass Spectrometry), which is the analytical gold standard for confirmatory drug detection and quantification.

8. The sample size for the training set

This document describes a diagnostic device (immunoassay), not a machine learning algorithm that requires a training set in the conventional sense. Therefore, there is no "training set" described. The development of such devices involves chemical and biological optimization, not data-driven model training.

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

As there is no training set for a machine learning model, this question is not applicable.

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OnTrak TesTcup and OnTrak TesTstik products, as listed below, are in vitro diagnostics tests On Flax Tes I cup and On Frak Test realitative detection of drugs in urine at or above the stated cutoff concentrations.
OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. On Frax Test cap and On Flair For roler por roler to obtain a confirmed analytical result.

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This looks like a 510(k) clearance letter for the OnTrak Test Tcup and OnTrak Test Tstik, which are in vitro diagnostics for the qualitative detection of drugs in urine.

Unfortunately, the provided document does not contain the detailed study information required to answer your request in full. The letter itself is a notice of substantial equivalence being granted by the FDA, and it typically refers to a submission that would contain such studies.

Here's what I can infer and what is missing based on the provided text:

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

• Acceptance Criteria: The "Cutoff Concentrations" table (Amphetamines 1000 ng/mL, Morphine 300 ng/mL, etc.) represents the critical threshold for qualitative detection, which implicitly serves as the acceptance criterion for a positive or negative result. A device is expected to correctly identify samples above the cutoff as positive and below as negative (within a certain margin of error and considering cross-reactivity).
• Reported Device Performance: This information is not present in the provided document. A 510(k) submission would typically include sensitivity, specificity, accuracy, and potentially cross-reactivity data against these cutoffs.

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

• This information is not present in the provided document.

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):

• This information is not present in the provided document. For drug tests, the "ground truth" is typically established by a reference method (e.g., GC/MS or LC/MS) not by human expert interpretation.

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

• This information is not present in the provided document. Adjudication methods are more relevant for subjective interpretations (like medical imaging). For a drug test, the ground truth is analytically determined.

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 is an in vitro diagnostic device (a test kit for drugs in urine), not an AI-powered diagnostic imaging tool. MRMC studies are not applicable here. The "reader" is typically a lab technician or user interpreting test lines, not a "human reader" in the AI sense.

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

• This is an in vitro diagnostic device. Its performance is inherent to the chemical reactions and readout mechanism. It doesn't have an "algorithm" in the AI sense. The device is the standalone test. The performance would be "algorithm only" in the sense that the test itself performs the detection.

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

• The ground truth for such drug tests is typically established using a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). The document explicitly states: "OnTrak TesTcup and OnTrak TesTstik products provide only a preliminary analytical test result. For a confirmed analytical result, secondary confirmatory method such as GC/MS must be used." This strongly implies that a confirmatory method like GC/MS was used to establish the ground truth in their studies.

8. The sample size for the training set:

• This information is not present in the provided document. As this is not an AI/machine learning device, the concept of a "training set" in that context does not apply. The device's formulation and design would be optimized through R&D, not trained on data.

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

• Not applicable as there is no "training set" in the context of AI/ML. The ground truth for the performance evaluation (test set) is established by a confirmatory analytical method (likely GC/MS or LC/MS) as mentioned in point 7.

In summary, the provided document is a regulatory clearance letter and not the scientific study report itself. Therefore, most of the detailed questions about study design, sample sizes, and expert involvement cannot be answered from this text.

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