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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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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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