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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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