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The ToxCup® Drug Screen Cup is an in vitro screening test for the rapid detection of multiple drugs and drug metabolites in human urine at or above the following cutoff concentration:

AMP Amphetamine 500 ng/ml
BAR Secobarbital 300 ng/ml
BUPG Buprenorphine Glucuronide 10 ng/ml
BZO Oxazepam 300 ng/ml
COC Benzoylecgonine 150 ng/ml
MDMA 3,4-methylenedioxymethamphetamine 500 ng/ml
MET Methamphetamine 500 ng/ml
MTD Methadone 300 ng/ml
OPI Morphine 300 ng/ml
OXY Oxycodone 100 ng/ml
PCP Phencyclidine 25 ng/ml
PPX Propoxyphene 300 ng/ml
TCA Nortriptyline 1000 ng/ml
THC 11-nor-Δ9-Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

These tests provide visual qualitative results and are intended for in vitro diagnostic use only. The ToxCup® Drug Screen Cup is available in single drug analyte cassette dip format and/or double drug analyte cassette dip format. It is intended for prescription point-of-care and overthe-counter consumer use.

These tests provide only a preliminary test result and are the first step in a two-step process for detecting drugs of abuse in urine. The second step is confirming the results in a certified laboratory. For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when a preliminary positive result is indicated.

The ToxCup® Drug Screen Cup is based on the principle of highly specific immunochemical reactions between antigens and antibodies. It utilizes a competitive immunoassay procedure in which an immobilized drug conjugate competes with the drug present in urine for limited antibody binding sites. The ToxCup® Drug Screen Cup device consists of individual test strips, in single drug analyte cassette dip format and/or double analyte cassette dip format, assembled into separate chambers of a plastic insert and can detect up to 14 drugs in human urine at various cutoff concentrations. The presence of a color band at a specific test region indicates a negative result for that particular test. The absence of a color band at a specific test region indicates presumptive positive result for that particular test.

A control band at the control region should always appear regardless of the presence of the drug or its metabolites. The presence of the control band during testing serves as a built in control which indicates that the test has completed and is valid.

The provided text describes the ToxCup® Drug Screen Cup, a qualitative lateral flow immunoassay for the rapid detection of multiple drugs and drug metabolites in human urine. The acceptance criteria and the study performance reported are based on Method Comparison studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criterion specified for the Method Comparison is a total % agreement of ≥ 95%. The text states that the predicate device (Amedica Home Drug Test Cup) had a total % agreement of ≥ 93%. While the specific percentages for the ToxCup® Drug Screen Cup are not detailed in the provided excerpt, the "Differences" table (Page 5) implies that the new device meets or exceeds this threshold, as it lists "≥ 95%" for "Method Comparison Total % agreement". The conclusion explicitly states: "The performance characteristics studies performed demonstrate substantial equivalency between the ToxCup® Drug Screen Cup, the predicate kit Amedica Home Drug Test Cup."

Important Note: The provided text only explicitly states the acceptance criterion for "Method Comparison Total % agreement" in the "Differences" table between the subject device and the predicate device. It does not provide specific numerical results for each drug analyte or for other performance characteristics like stability, optimal read time, precision/reproducibility, or specificity/interference, beyond listing that these studies were performed.

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

The provided summary does not explicitly state the sample size used for the test set in the Method Comparison study, nor does it mention the country of origin of the data or whether the study was retrospective or prospective.

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

The document does not provide information about experts used to establish ground truth for the test set. Drug screening tests like this typically use laboratory-confirmed quantitative methods (e.g., GC/MS) as the gold standard for ground truth, rather than expert interpretation of the rapid test results.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This type of device provides a visual qualitative result (presence or absence of a color band) and the "ground truth" is typically established by an independent, more definitive laboratory method.

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

The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study (MRMC) is generally more relevant for imaging devices where human interpretation is a primary factor. The ToxCup® is a rapid immunoassay for drugs in urine.

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

The device itself is a standalone, qualitative lateral flow immunoassay. Its performance characteristics, such as the Method Comparison, are evaluated based on the device's ability to produce a correct visual result (positive or negative) compared to a gold standard. Human interpretation of the result is part of how the device is used (reading the presence or absence of a color band), but the performance studies focus on the accuracy of the test itself. There is no "algorithm only" component in the traditional sense of AI/image analysis without human-in-the-loop performance, as the device's output is the visual result.

7. The Type of Ground Truth Used

The ground truth for preliminary positive results is established by a "more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS)." This is explicitly stated: "For a quantitative result or to confirm preliminary positive results obtained by the ToxCup® Drug Screen Cup, a more specific alternative method such as Gas Chromatography/Mass Spectrometry (GC/MS) must be used." This is a gold standard laboratory method for drug detection and quantification.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. Immunoassays like the ToxCup® are designed and optimized through a development process, but they don't typically involve "training sets" in the same way machine learning algorithms do. The performance studies described (Precision/reproducibility, Method Comparison, Specificity and Interference, Consumer Study, etc.) are verification and validation studies of the developed product.

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, there is no description of how ground truth for such a set was established. The development of such an immunoassay would involve standard laboratory practices and analytical chemistry to determine appropriate antibody and antigen concentrations and reaction conditions to achieve desired sensitivity and specificity.

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The ToxCup™ Drug Screen Cup is an in vitro screen test that contains chromatographic immunoassays for the rapid detection of amphetamines, cocaine (benzoylecgonine), methamphetamines, opiates, phencyclidine and THC in human urine at the following cutoff concentrations:

AMP d-Amphetamine 1000 ng/ml
COC Benzoylecgonine 300 ng/ml
MET500 d-Methamphetamine 500 ng/ml
OPI2000 Morphine 2000 ng/ml
OPI300* Morphine 300 ng/ml
PCP Phencyclidine 25 ng/ml
THC 11-nor-Delta^9 -Tetrahydrocannabinol-9-carboxylic acid 50 ng/ml

*The Opiates test is offered at the SAMHSA mandated cut-off concentration of 2000 ng/ml and the optional cu-off concentration indicated.

The ToxCup™ Drug Screen Cup provides visual, qualitative results for multiple drugs-ofabused in human urine. The device is intended for professional in vitro diagnostic use only. It is not intended for over-the-counter sale to lay persons.

Not Found

This looks like information from a 510k submission to the FDA for a drug screening cup. The document is primarily an FDA clearance letter and an "Indications For Use" statement. It does not contain the detailed study information needed to describe acceptance criteria and device performance in the way requested.

Specifically, the document does not provide:

• A table of acceptance criteria and reported device performance beyond the cutoff concentrations. While it lists the cutoff concentrations, it doesn't give sensitivity, specificity, accuracy, or other performance metrics against these cutoffs.
• Sample sizes for the test set or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance (this is a physical test device, not an algorithm).
• The specific type of ground truth used (e.g., confirmatory lab results).
• Sample size or ground truth establishment for a training set (again, this is a physical test, not an AI/ML algorithm).

The only relevant information that can be extracted related to "acceptance criteria" (in the sense of target concentrations for detection) is from the "Indications For Use" table:

1. Table of Acceptance Criteria (Cutoff Concentrations) and Reported Device Performance (Implied target for detection):

Regarding the other points, the document provides insufficient information:

2. Sample size used for the test set and the data provenance: 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: Not provided in the document.
4. Adjudication method for the test set: Not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable for this type of device (drug screening cup, not AI assistance for human readers).
6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done: Not applicable for this type of device (physical test, not an algorithm).
7. The type of ground truth used: Not explicitly stated, but for drug screens, it would typically be confirmed by a more precise analytical method like GC-MS.
8. The sample size for the training set: Not applicable/provided. This is not an AI/ML device that uses a "training set" in that sense.
9. How the ground truth for the training set was established: Not applicable/provided.

To get the detailed study information regarding sensitivity, specificity, positive predictive value, negative predictive value, exact sample sizes, and how ground truth was established (e.g., confirmatory GC-MS), one would typically need to refer to the full 510(k) submission document or the device's Instructions For Use (IFU). This document is just the FDA clearance letter and indications for use.

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