(202 days)
The Rapid TOX Cup II is an in vitro diagnostic drugs of abuse testing device intended for use in the qualitative detection of the following drugs of abuse testing in a human urine specimen: Amphetamines, Barbiturates (Butalbital), Benzodiazepines (Oxazepam), Buprenorphine, Cocaine, MDMA (Methylenedioxymethamphetamine), Methadone, Methamphetamine, Opiates, Oxycodone, Phencyclidine, Marijuana, Tricyclic Antidepressants. The test is intended for over-the-counter use.
Rapid TOX Cup II is a drug test that can detect 1 to 13 drugs in human urine. Rapid TOX Cup II is collection cup with a temperature strip attached. It contains an insert with one or more test strips in the insert. Each test strip can test for up to 4 different drugs. The test is for over-the-counter or professional use. Rapid TOX CUP II is a first step in a 2-step process. The test provides information about the presence of certain drugs in urine. The second step in the process is more specific testing by a laboratory.
Here is a description of the acceptance criteria and the study proving the device meets them, based on the provided text:
This document describes the performance of the Rapid TOX Cup II, a urine drug screening device.
1. Table of Acceptance Criteria and Reported Device Performance
The device is an in vitro diagnostic test designed to qualitatively detect various drugs of abuse in human urine. The acceptance criteria are implicit in the "consumer study" results, which show the device's accuracy at different drug concentrations relative to predefined cutoffs. The "acceptance criteria" are not explicitly stated as numerical targets (e.g., Sensitivity > X%, Specificity > Y%), but rather demonstrated through the concordance of the device's positive and negative results with expected outcomes based on the spiked concentrations.
Below is a summary table demonstrating the device's performance for each tested drug across different concentrations, as reported in the consumer study. The "Rapid TOX Cup II Result" indicates how the device interpreted the prepared samples.
Table 1: Rapid TOX Cup II Reported Device Performance (Consumer Study Results)
| Drug Name | Cutoff (ng/mL) | Urine Sample Type (Ground Truth) | Rapid TOX Cup II Result (Device Performance) | Number of Samples |
|---|---|---|---|---|
| AMP (Amphetamines) | 500 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 5 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 35 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| AMP (Amphetamines) | 1000 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BAR (Barbiturates) | 300 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BZO (Benzodiazepines) | 300 | No Drug Present | NEGATIVE | 880 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| BUP (Buprenorphine) | 12.5 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| COC (Cocaine) | 150 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| COC (Cocaine) | 300 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | MEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| MDMA | 500 | No Drug Present | NEGATIVE | 80 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 4 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 36 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| MTD (Methadone) | 300 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| METH (Methamphetamine) | 500 | No Drug Present | NEGATIVE | 80 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| METH (Methamphetamine) | 1000 | No Drug Present | NEGATIVE | 500 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OPI (Opiates) | 300 | No Drug Present | NEGATIVE | 160 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OPI (Opiates) | 2000 | No Drug Present | NEGATIVE | 620 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 3 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 37 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| OXY (Oxycodone) | 100 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| PCP (Phencyclidine) | 25 | No Drug Present | NEGATIVE | 860 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| THC (Marijuana) | 50 | No Drug Present | NEGATIVE | 960 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 1 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 39 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 | ||
| TCA (Tricyclic Antidepressants) | 1000 | No Drug Present | NEGATIVE | 580 |
| Less than 50% of cutoff | NEGATIVE | 20 | ||
| Between 50% below cutoff and cutoff | POSITIVE | 2 | ||
| Between 50% below cutoff and cutoff | NEGATIVE | 38 | ||
| Between cutoff and 50% above cutoff | POSITIVE | 40 | ||
| Greater than 50% above cutoff | POSITIVE | 20 |
Interpretation of Performance:
The results indicate that:
- For samples with "No Drug Present" or "Less than 50% of the cutoff concentration," the device predominantly yielded NEGATIVE results, demonstrating high specificity below the cutoff.
- For samples "Between the cutoff and 50% above the cutoff concentration" and "Greater than 50% above the cutoff concentration," the device consistently yielded POSITIVE results, demonstrating high sensitivity at or above the cutoff.
- For samples "Between 50% below the cutoff and the cutoff concentration," there was a mix of positive and negative results, which is expected for lateral flow assays as performance at these "near cutoff" concentrations can vary. However, the majority of these samples still yielded NEGATIVE results, indicating appropriate cutoff performance.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The sample sizes vary per drug type and concentration level. For each drug and cutoff level, there were:
- Between 80 and 960 samples for "No Drug Present" (Negative).
- 20 samples for "Less than 50% of the cutoff."
- 40 samples for "Between 50% below the cutoff and the cutoff."
- 40 samples for "Between the cutoff and 50% above the cutoff."
- 20 samples for "Greater than 50% above the cutoff."
- This totals approximately 140 to 1080 samples per drug/cutoff combination for the consumer study. The document lists 17 unique drug/cutoff combinations, meaning the total number of individual tests performed in the consumer study would be significant.
- Data Provenance: The data was generated through a prospective consumer study. The document does not specify the country of origin for the data or the participants, but given the FDA submission, it is likely that the study was conducted in the United States or in accordance with US regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Experts and Qualifications: The document does not mention the use of human experts (e.g., radiologists) to establish ground truth for this medical device.
- Ground Truth Establishment: The ground truth for the test set was established by preparing samples with known concentrations of drug analytes. These are "spiked" samples with precise, known quantities of the drugs or their metabolites, relative to the device's specified cutoff levels. This is a common and robust method for establishing ground truth in in vitro diagnostic studies.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As the ground truth was established by known concentrations in prepared samples, there was no need for adjudication among human readers or experts. The device's output (positive/negative) was compared directly to the known concentration of the spiked sample.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This type of study is typically relevant for interpretative devices (e.g., AI in radiology) where human readers are involved in the interpretation process. The Rapid TOX Cup II is an in vitro diagnostic device that provides a direct "positive" or "negative" qualitative result.
- Effect Size of Human Readers Improvement: Not applicable, as no MRMC study was conducted. The study's purpose was to show the device's performance when interpreted by "untrained consumers" in an OTC setting, comparing their interpretation of the device's visual readout to the true spiked concentrations, rather than comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Performance: Not explicitly separated as "algorithm only." The device itself (the Rapid TOX Cup II) is the "algorithm" in this context (a lateral flow immunoassay). The study evaluated how well untrained consumers could generate a result and interpret it from the physical device. Therefore, the reported performance is effectively the "standalone performance" of the device as it would be used by an end-user, including the user's interpretation of the visual output. The device is not an AI algorithm in the traditional sense that operates independently of a user interface or human input for interpretation.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth used was known, prepared concentrations of drug analytes in urine samples. This is a form of "laboratory-controlled" or "spiked sample" ground truth, which is highly precise and accurate for evaluating the analytical performance of in vitro diagnostic tests. While clinical outcomes or expert consensus might be used for other types of devices, for a rapid drug screen, known concentrations are the gold standard for analytical validation.
8. Sample Size for the Training Set
- Training Set Sample Size: The document does not mention a "training set" in the context of machine learning or AI algorithm development. The Rapid TOX Cup II is a chemical immunoassay, not an AI or machine learning model. Therefore, the concept of a "training set" and "test set" in the AI sense does not apply to the device's development or validation in this document. The samples described were used for a performance validation study (akin to a test set in the analytical validation context).
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for an immunoassay device. The ground truth for the validation study (the "consumer study") was established by precisely preparing urine samples with known concentrations of drug analytes, as detailed in point 7.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).