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510(k) Data Aggregation
(202 days)
Rapid Tox Cup II
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.
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(212 days)
RAPID TOX CUP
Rapid Tox Cup™ is a one-step, lateral flow immunoassay contained in a polypropylene cup for the simultaneous detection of abused drugs in urine. 'Rapid Tox Cup'- is intended for use in the qualitative detection of the following 14 drugs of abuse in human urine at the following levels:
Amphetamine 1000 ng/mL
Amphetamine 500 ng/mL
Methamphetamine 1000 ng/mL
Methamphetamine 500 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 1000 ng/mL
3,4-methylenedioxymethamphetamine (MDMA) 500 ng/mL
Buprenorphine 12.5 ng/mL
Benzodiazepines (Oxazepam) 300 ng/mL
Barbiturates (Butalbital) 300 ng/mL
Oxycodone 100 ng/mL
Methadone 300 ng/mL
Phencyclidine 25 ng/mL
Propoxyphene 300 ng/mL
Opiates 300 ng/mL
Opiates 2000 ng/mL
Cocaine (Benzoylecgonine) 300 ng/mL
Cocaine (Benzoylecgonine) 150 ng/mL
Tricyclic Antidepressants (Nortriptyiline) 1000 ng/mL
THC/ Cannabinoids (11 nor△9-THC-9-carboxylic acid) 50 ng/mL
'Rapid Tox Cup' is intended for professional use. It is not intended for over-the-counter sale to non-professionals. This assay is a simplified screening method that provides only a preliminary result for use in determining the need for additional or confirmatory testing, i.e. gas-chromatography/mass spectrometry (GC/MS).
The barbiturate BAR, benzodiazepine BZO and tricyclic antidepressant TCA will yield preliminary positive results when BAR, BZO, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, or tricyclic antidepressant in urine. Certain foods or medicines may interfere with tests for Barbiturates, Benzodiazepines, and Tricyclic Antidepressants and may cause positive results.
There is no calibration necessary and therefore no calibrator needed for this device.
'Rapid Tox Cup' provides only a preliminary analytical result. A more specific alternate method must be used in order to obtain a more confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical and professional judgment should be applied to any drug of abuse result, particularly when preliminary positive results are used.
The immunoassays employed in each test strip of the 'Rapid Tox Cup' are based on the same principle of the highly specific reaction between antigens and antibodies.
Each assay consists of a membrane strip onto which up to five different drug conjugates have been immobilized. A colloidal gold-antibody complex consisting of up to five antibodies is dried at one end of the membrane. In the absence of any drug in the urine sample, the colloidal gold-multi-antibody complex moves with the urine sample by capillary action to contact the immobilized drug conjugate. Antibody-antigen reactions occur forming a visible line in all "test" areas. The formation of a visible line in the test areas occur when the test is negative for the adjacent labeled drug.
When drug is present in the urine sample, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the limited antibody binding sites on the colloidal gold-labeled antibody complex, thus preventing attachment of the labeled antibody to the drug conjugate. An absence of a colored line in any of the test areas is indicative of a presumptive positive result.
A control line, comprised of a different antibody/antigen reaction, is present on the membrane strip. The control line is not influenced by the presence or absence of a drug in the urine, and therefore, should be present in all reactions.
A negative urine will produce up to six colored lines, and a positive sample will produce a colored line in the control area and no colored line(s) in the test area corresponding to the individual analyte(s) that are present in the sample.
The device is contained in a polypropylene cup.
The provided document describes the "Rapid Tox Cup," a one-step, lateral flow immunoassay for the simultaneous detection of abused drugs in urine.
1. Acceptance Criteria and Reported Device Performance
The document presents targeted drug concentrations (cut-off levels) for detection. These can be considered the acceptance criteria for individual drug detection sensitivity. The study claims the device's performance is reproducible and equivalent to its predicate devices.
| Analyte (Drug) | Acceptance Criteria (Cut-off level) | Reported Device Performance (Specificity/Sensitivity) |
|---|---|---|
| Amphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Amphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 500 ng/mL | Reproducible, equivalent to predicate devices |
| Methamphetamine | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Reproducible, equivalent to predicate devices |
| 3,4-methylenedioxymethamphetamine (MDMA) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| Buprenorphine | 12.5 ng/mL | Reproducible, equivalent to predicate devices |
| Benzodiazepines (Oxazepam) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Barbiturates (Butalbital) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Oxycodone | 100 ng/mL | Reproducible, equivalent to predicate devices |
| Methadone | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Phencyclidine | 25 ng/mL | Reproducible, equivalent to predicate devices |
| Propoxyphene | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Opiates | 2000 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 300 ng/mL | Reproducible, equivalent to predicate devices |
| Cocaine (Benzoylecgonine) | 150 ng/mL | Reproducible, equivalent to predicate devices |
| Tricyclic Antidepressants (Nortriptyline) | 1000 ng/mL | Reproducible, equivalent to predicate devices |
| THC/ Cannabinoids (11 nor△9-THC-9-carboxylic) | 50 ng/mL | Reproducible, equivalent to predicate devices |
Note: The performance is described as "reproducible" and "equivalent to predicate devices," but specific accuracy metrics (e.g., sensitivity, specificity, PPV, NPV) from the study are not provided in this summary. The performance is inferred from the demonstration of reproducibility and equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The reproducibility study used commercially available control urines.
- Sample Size: Each sample was tested 4 times, twice daily, for 5 days, for a total of 40 tests per sample. The specific number of distinct control urine samples (e.g., negative controls, above cut-off, below cut-off) used is not explicitly stated.
- Data Provenance: The document does not specify the country of origin of the data. The data appears to be from a prospective study conducted for validation purposes, given the controlled testing conditions (commercially available control urines, specific testing regimen).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set (control urines) was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is a laboratory analytical method, not by human experts. Therefore, the information about the number and qualifications of experts is not applicable in this context.
4. Adjudication Method for the Test Set
Since the ground truth was established by GC/MS and the device provides a direct qualitative result (visible line or no line), there was no adjudication method described for resolving discrepancies in the test set. The results from the device were compared against the GC/MS verified concentrations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The device is an immunoassay that provides a direct qualitative result, not an imaging device requiring human interpretation, so such a study would not be typically applicable. The comparison was the device's performance against GC/MS-verified samples.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The reproducibility study evaluated the performance of the "Rapid Tox Cup" by testing control urines multiple times and verifying concentrations by GC/MS. This assesses the algorithm's (or, in this case, the immunoassay's) performance without human-in-the-loop interpretation beyond reading the visible lines. It also explicitly states that the device in cup form houses identical strips used in predicate devices, and testing showed "no difference relative to results from the Rapid Tec or Rapid Tox products."
7. The Type of Ground Truth Used
The ground truth used for the test set was laboratory analytical confirmation by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted method for drug concentration verification.
8. The Sample Size for the Training Set
The document does not specify a distinct training set sample size. The description of the device's technology (immunoassay with immobilized drug conjugates and colloidal gold-antibody complex) suggests that its "training" or development involved setting up the specific chemical reactions and cutoff concentrations. While this process would involve extensive testing and optimization, the document refers to validation studies rather than a formal "training set" in the machine learning sense. The performance characteristics were evaluated using commercially available control urines for reproducibility.
9. How the Ground Truth for the Training Set Was Established
As with the test set, the ground truth for optimizing or validating the device's detection capabilities (analogous to a training set's ground truth in AI) would have been established through laboratory analytical methods, most likely GC/MS, to accurately determine drug concentrations in samples used during the development and optimization phases. The summary states that "All concentrations were verified by GC/MS" for the reproducibility study, indicating this method for ground truth establishment.
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