(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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 15, 2017
AMERICAN BIO MEDICA CORPORATION MELISSA WATERHOUSE, CEO 122 SMITH ROAD KINDERHOOK, NY 12106
Re: K170222
Trade/Device Name: Rapid Tox Cup II Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: LAF, DIO, DJG, DJR, LDJ, DKZ, JXM, DIS, LCM, LFG Dated: July 6, 2017 Received: July 10, 2017
Dear Ms. Waterhouse:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements
{1}------------------------------------------------
as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Summary
Fax: 518-758-8171
Email: mdwaterhouse@abmc.com
| Date of Summary: | August 15, 2017 |
|---|---|
| Sponsor and Correspondent: | American Bio Medica Corporation122 Smith Road |
| Kinderhook, NY 12106Attention: Melissa A. WaterhousePhone: 800-227-1243 x 107 |
Device Identification:
| Trade or Proprietary Name: | Rapid TOX Cup II |
|---|---|
| Common Name: | Urine Drug of Abuse Rapid Screening Test |
| Device Class: | Class II |
| Panel: | Toxicology |
Product Classifications and Regulation Section:
| LAF | Methamphetamine | 21 CFR 862.3610 | |||
|---|---|---|---|---|---|
| DIO | Cocaine | 21 CFR 862.3250 | DJG | Opiates | 21 CFR 862.3650 |
| DJR | Methadone | 21 CFR 862.3620 | DIS | Barbiturates | 21 CFR 862.3150 |
| LDJ | THC/Cannabinoids | 21 CFR 862.3870 | JXM | Benzodiazepine | 21 CFR 862.3170 |
| DKZ | Amphetamine | 21 CFR 862.3100 | DJG | Buprenorphine | 21 CFR 862.3650 |
| LAF | MDMA | 21 CFR 862.3610 | DJG | Oxycodone | 21 CFR 862.3650 |
| LCM | Phencyclidine | Unclassified,510(k) required | LFG | TricyclicAntidepressants | 21 CFR 862.3910 |
Substantial Equivalency
The Rapid TOX Cup II, a urine drug screen, is substantially equivalent to the Rapid TOX Cup (K073078). Table 2 compares the characteristics of the Rapid TOX Cup II (New Device) and the Rapid TOX Cup (Predicate Device). The table below gives a comparison of the new device with the predicate device.
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| NEW DEVICERapid TOX Cup II | PREDICATE DEVICERapid TOX Cup | |
|---|---|---|
| 510(k) Number | N/A | K073078 |
| FEATURES | SIMILARITIES | |
| Classification Code | LAF, DIO, DJR, LDJ, DKZ, LCM, DJG, DIS, JXM,LFG | LAG,DIO, DJG, DJR, DKE, DKZ, JXM, JXN, LCMLFI |
| Device Class | II | II |
| Intended Use | Rapid TOX Cup II is a drug test that candetect 1 to 13 drugs in human urine.Rapid TOX Cup II is collection cup with atemperature strip attached. It contains aninsert with one or more test strips in theinsert. Each test strip can test for up to 4different drugs.The test is for over-the-counter orprofessional use. Rapid TOX CUP II is a firststep in a 2-step process. The test providesinformation about the presence of certaindrugs in urine. The second step in theprocess is more specific testing by alaboratory.Amphetamines (d-amphetamine sulfate)(1000 & 500 ng/mL)Barbiturates (butalbital) (300 ng/mL)Benzodiazepines (oxazepam) (300 ng/mL)Buprenorphine (12.5 ng/mL)Cocaine (benzoylecgonine) (300 & 150 ng/mL)MDMA ((+/-) 3,4-methylenedioxy-methamphetamine) (Ecstasy) (500 ng/mL)Methadone (300 ng/mL)Methamphetamines ((+)methamphetamineHCl) (1000 & 500 ng/mL)Opiates (morphine-3-b-D-glucuronide) (2000& 300 ng/mL)Oxycodone (100 ng/mL)Phencyclidine (phencyclidine HCl) (25 ng/mL)THC/ Cannabinoids (11-nor-Δ9-THC-9-carboxylic-acid) (50 ng/mL)Tricyclic Antidepressants (nortriptyline) (1000ng/mL) | Rapid TOX Cup™ is a one-step, lateral flowimmunoassay contained in a polypropylenecup for the simultaneous detection ofabused drugs in urine. Rapid TOX Cup - isintended for use in the qualitativedetection of the following drugs of abusein human urine at the following levels:Amphetamine 1000 ng/mLAmphetamine 500 ng/mLMethamphetamine 1000 ng/mLMethamphetamine 500 ng/mL3,4-methylenedioxymethamphetamine (MDMA)1000 ng/mL3,4-methylenedioxymethamphetamine (MDMA) 500ng/mLBuprenorphine 12.5 ng/mLBenzodiazepines (Oxazepam) 300 ng/mLBarbiturates (Butalbital) 300 ng/mLOxycodone 100 ng/mLMethadone 300 ng/mLPhencyclidine 25 ng/mL Propoxyphene 300 ng/mLOpiates 300 ng/mLOpiates 2000 ng/mLCocaine (Benzoylecgonine) 300 ng/mLCocaine (Benzoylecgonine) 150 ng/mLTricyclic Antidepressants (Amitriptyline) 1000 ng/mLTHC/ Cannabinoids (11 norΔ9-THC-9-carboxylic 50ng/mLacid)Rapid TOX Cup is intended for professional use. It isnot intended for over-the-counter sale to non-professionals. This assay is a simplified screeningmethod that provides only a preliminary result foruse in determining the need for additional orconfirmatory testing, i.e. gas-chromatography/massspectrometry (GC/MS). |
| Assay Results | Qualitative | Qualitative |
| DIFFERENCES | ||
| Intended use | Over-the-counter use and professional use | For professional use only |
| Intended users | Untrained Consumers and TrainedProfessionals | Trained Professionals |
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Intended Use
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:
| Analyte | Calibrator Drug | Cutoff (ng/mL) |
|---|---|---|
| Amphetamines | D-amphetamine | 1000 |
| Amphetamines | D-amphetamine | 500 |
| Barbiturates (Butalbital) | Butalbital | 300 |
| Benzodiazepines (Oxazepam) | Oxazepam | 300 |
| Buprenorphine | Buprenorphine | 12.5 |
| Cocaine | Benzoylecgonine | 300 |
| Cocaine | Benzoylecgonine | 150 |
| MDMA | MDMA(Methylenedioxymethamphetamine) | 500 |
| Methadone | Methadone | 300 |
| Methamphetamine | D-methamphetamine | 1000 |
| Methamphetamine | D-methamphetamine | 500 |
| Opiates | Morphine | 2000 |
| Opiates | Morphine | 300 |
| Oxycodone | Oxycodone | 100 |
| Phencyclidine | Phencyclidine | 25 |
| Marijuana | 11-nor-Δ9-THC-9-carboxylic-acid | 50 |
| Tricyclic Antidepressants | Nortriptyline | 1000 |
The test is intended for over-the-counter use.
This assay may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assay is not intended to distinguish between prescription use or abuse of these drugs.
Rapid TOX Cup II 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.
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Methodology
Each Rapid TOX Cup II test device contains test strips for drugs of abuse that are one-step immunoassays. The specifically labeled drug (drug conjugate) competes for antibody binding sites with drugs or metabolites that may be present in the urine specimen. The test strip consists of a membrane strip with an immobilized drug conjugate. A colloidal gold-labeled antibody (mouse or rabbit) complex is dried at one end of the membrane.
A control line, comprised of a different antibody/antigen reaction (Goat Anti-Mouse or Goat Anti-Rabbit), is present on the membrane strip. The control line is not influenced by the presence or absence of a drug analyte in the urine specimen, and therefore, it should be present in all reactions. In the absence of any drug in the urine specimen, the colloidal goldlabeled antibody complex moves with the urine by capillary action to contact the immobilized drug conjugate. An antibody-antigen reaction occurs forming a visible line in the "test" area. The formation of two (2) visible lines (control and test lines) occurs when the test is negative or below the cut-off for the drug. When a drug analyte is present in the urine specimen, the drug or metabolite will compete with the immobilized drug conjugate in the test area for the antibody binding sites on the colloidal gold-labeled antibody complex. If a sufficient amount of drug analyte is present, it will fill all of the available binding sites, thus preventing attachment of the labeled antibody to the drug conjugate. The formation of a control line and the absence of a test line are indicative of a preliminary positive result.
This assay provides a preliminary test result for several drugs simultaneously. A more specific alternative test method must be used to obtain a confirmed, analytical result. Gas chromatography / mass spectrometry (GC/MS) and Gas chromatography / mass spectrometry (tandem MS) (GC-MS/MS) are the preferred confirmatory assays. Alternatively confirmatory assays may be Liquid chromatography Mass spectrometry (tandem MS) LC-MS/MS or HPLC.
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To demonstrate the performance of the Rapid TOX Cup II by untrained consumers, consumer study participants were recruited in a user study to test prepared samples, generate a result and interpret the result. A summary of study results is included in the table below.
| Negative | LowNegative | NearNegative | NearPositive | HighPositive | ||
|---|---|---|---|---|---|---|
| DrugName | Rapid TOXCup IIResult | No DrugPresent | Less than50% ofthe cutoffconcen-tration | Between50% belowthe cutoffand thecutoffconcen-tration | Between thecutoff and50% abovethe cutoffconcen-tration | Greaterthan 50%above thecutoffconcen-tration |
| AMP | POSITIVE | 0 | 0 | 5 | 40 | 20 |
| 500 ng/mL | NEGATIVE | 160 | 20 | 35 | 0 | 0 |
| AMP | POSITIVE | 0 | 0 | 1 | 40 | 20 |
| 1000 ng/mL | NEGATIVE | 580 | 20 | 39 | 0 | 0 |
| BAR | POSITIVE | 0 | 0 | 3 | 40 | 20 |
| 300 ng/mL | NEGATIVE | 860 | 20 | 37 | 0 | 0 |
| BZO | POSITIVE | 0 | 0 | 3 | 40 | 20 |
| 300 ng/mL | NEGATIVE | 880 | 20 | 37 | 0 | 0 |
| BUP | POSITIVE | 0 | 0 | 2 | 40 | 20 |
| 12.5 ng/mL | NEGATIVE | 860 | 20 | 38 | 0 | 0 |
| COC | POSITIVE | 0 | 0 | 2 | 40 | 20 |
| 150 ng/mL | NEGATIVE | 160 | 20 | 38 | 0 | 0 |
| COC | POSITIVE | 0 | 0 | 1 | 40 | 20 |
| 300 ng/mL | NEGATIVE | 580 | 20 | 39 | 0 | 0 |
| MDMA | POSITIVE | 0 | 0 | 4 | 40 | 20 |
| 500 ng/mL | NEGATIVE | 80 | 20 | 36 | 0 | 0 |
| MTD | POSITIVE | 0 | 0 | 1 | 40 | 20 |
| 300 ng/mL | NEGATIVE | 860 | 20 | 39 | 0 | 0 |
| METH | POSITIVE | 0 | 0 | 3 | 40 | 20 |
| 500 ng/mL | NEGATIVE | 80 | 20 | 37 | 0 | 0 |
| METH | POSITIVE | 0 | 0 | 2 | 40 | 20 |
| 1000 ng/mL | NEGATIVE | 500 | 20 | 38 | 0 | 0 |
| OPI | POSITIVE | 0 | 0 | 3 | 40 | 20 |
| 300 ng/mL | NEGATIVE | 160 | 20 | 37 | 0 | 0 |
| OPI | POSITIVE | 0 | 0 | 3 | 40 | 20 |
| 2000 ng/mL | NEGATIVE | 620 | 20 | 37 | 0 | 0 |
| OXY | POSITIVE | 0 | 0 | 1 | 40 | 20 |
| 100 ng/mL | NEGATIVE | 860 | 20 | 39 | 0 | 0 |
| PCP | POSITIVE | 0 | 0 | 2 | 40 | 20 |
| 25 ng/mL | NEGATIVE | 860 | 20 | 38 | 0 | 0 |
| THC | POSITIVE | 0 | 0 | 1 | 40 | 20 |
| 50 ng/mL | NEGATIVE | 960 | 20 | 39 | 0 | 0 |
| TCA | POSITIVE | 0 | 0 | 2 | 40 | 20 |
| 1000 ng/mL | NEGATIVE | 580 | 20 | 38 | 0 | 0 |
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Statement of Safety and Effectiveness
The submitted information in the premarket notification is complete and supports a substantial equivalence for OTC use of the Rapid TOX Cup II.
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§ 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).