(266 days)
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No
The device description and performance studies describe a standard immunochromatographic assay (lateral flow test) for drug detection, which does not inherently involve AI or ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is described as an "in vitro diagnostic" test for detecting drugs in oral fluid, which is for diagnostic purposes, not therapeutic intervention or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid." The text also specifies "For in vitro diagnostic use only," which confirms its function as a diagnostic device.
No
The device description clearly states it is an immunochromatographic assay using a lateral flow system, which is a hardware-based test strip, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Definition of IVD: An in vitro diagnostic device is a medical device that is used to perform tests on samples such as blood, urine, or tissue, to detect diseases or other conditions. This device tests human oral fluid for the presence of specific drugs.
- Purpose: The device is intended to provide preliminary test results for the detection of drugs in human oral fluid, which is a diagnostic purpose.
- Device Description: The description details an "immunochromatographic assay that uses a lateral flow system for the qualitative detection of... in human oral fluid," which is a common format for IVD tests.
Therefore, based on the provided information, this device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The OralTox Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9 Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 40 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
DJC, DIO, DJG, LCM, LDJ, DKZ
Device Description
The OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Description of the test set: Oral fluid samples.
Sample size:
Precision-Reproducibility-Cut-Off studies: 60 samples per concentration per lot for each drug for total of 10 concentration levels and 3 lots.
Interference studies: Not specified
Specificity studies: Not specified, but involved testing various drug metabolites and other compounds.
Effect of Oral fluid pH: Oral fluid samples with pH 4 to 9, spiked with target drugs at 50% below and 50% above Cut-Off levels.
Drug Recovery Study: Negative oral fluid samples spiked to -50% and +50% of the cutoff.
Method comparison studies: A total of 852 samples tested across three sites.
Data source: Drug-free oral fluid, spiked oral fluid samples. For method comparison, samples were compared to LC-MS/MS results.
Annotation protocol: For Precision-Reproducibility-Cut-Off studies, all sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Each drug concentration was confirmed by LC/MS/MS.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
-
a. Precision-Reproducibility-Cut-Off
- Study type: This study evaluated the precision and reproducibility of the device at various concentrations relative to the cutoff, using three different lots.
- Sample size: For each drug, 60 samples were tested per concentration level (-100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off). This was done for 3 lots.
- Key results: The tables show the number of positive and negative results for each concentration level and drug across the three lots. The results indicate varying performance near the cutoff, with higher accuracy further from the cutoff.
- Amphetamine: At cutoff, Lot 1: 53+/7-, Lot 2: 51+/9-, Lot 3: 49+/11-.
- Cocaine: At cutoff, Lot 1: 52+/8-, Lot 2: 50+/10-, Lot 3: 48+/12-.
- Methamphetamine: At cutoff, Lot 1: 50+/10-, Lot 2: 49+/11-, Lot 3: 48+/12-.
- Morphine: At cutoff, Lot 1: 48+/12-, Lot 2: 48+/12-, Lot 3: 50+/10-.
- Phencyclidine: At cutoff, Lot 1: 48+/12-, Lot 2: 49+/11-, Lot 3: 48+/12-.
- Cannabinoids: At cutoff, Lot 1: 54-/6+, Lot 2: 54-/6+, Lot 3: 55-/5+.
-
b. Linearity: Not applicable.
-
c. Stability:
- Study type: Accelerated stability study.
- Key results: The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C.
-
d. Interference:
- Study type: Evaluated potential interference from various substances including common medications, food items, hemoglobin, and cigarette smoking.
- Key results: None of the listed substances showed interference at specified concentrations. Hemoglobin showed no interference at 100 µg/mL. Cigarette smoking showed no interference.
-
e. Specificity:
- Study type: Cross-reactivity study with drug metabolites and other components.
- Key results: Detailed cross-reactivity percentages are provided for each drug with various related compounds and potential interfering substances. For example, d-Methamphetamine showed 100% cross-reactivity with Methoxymethamphetamine, while Amphetamine showed 0.05% cross-reactivity.
-
f. Effect of Oral fluid pH:
- Study type: Tested oral fluid samples with varying pH levels.
- Key results: Results were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off, across pH 4 to 9.
-
g. Drug Recovery Study:
- Study type: Evaluated drug recovery from oral fluid samples stored in the devices.
- Key results: Over 90% recoveries were observed for all drugs. Oral fluid samples can be stored in the device at -20℃ for at least 3 months, and can be shipped overnight for LC-MS confirmation.
2. Comparison Studies
- Study type: Method comparison studies with LC-MS/MS results.
- Sample size: A total of 852 samples.
- Key results: Percentage of correct results compared to LC-MS/MS for various concentration ranges (Drug-Free, Less than Half the Cutoff, Near Cutoff Negative, Near Cutoff Positive, High Positive). Discordant results are also listed.
- Methamphetamine:
- Drug-Free: 100% correct (324/324)
- Less than Half the Cutoff: 100% correct (50/50)
- Near Cutoff Negative: 87% correct (13/15)
- Near Cutoff Positive: 94% correct (15/16)
- High Positive: 100% correct (116/116)
- Cocaine:
- Drug-Free: 100% correct (390/390)
- Less than Half the Cutoff: 100% correct (21/21)
- Near Cutoff Negative: 95% correct (18/19)
- Near Cutoff Positive: 93% correct (14/15)
- High Positive: 100% correct (77/77)
- Morphine:
- Drug-Free: 100% correct (323/323)
- Less than Half the Cutoff: 100% correct (50/50)
- Near Cutoff Negative: 88% correct (14/16)
- Near Cutoff Positive: 95% correct (18/19)
- High Positive: 100% correct (114/114)
- Amphetamine:
- Drug-Free: 100% correct (229/229)
- Less than Half the Cutoff: 100% correct (92/92)
- Near Cutoff Negative: 97% correct (rate)
- Near Cutoff Positive: 92% correct (36/39)
- High Positive: 100% correct (20/20)
- Phencyclidine:
- Drug-Free: 100% correct (407/407)
- Less than Half the Cutoff: 100% correct (20/20)
- Near Cutoff Negative: 75% correct (6/8)
- Near Cutoff Positive: 100% correct (4/4)
- High Positive: 100% correct (38/38)
- Cannabinoids:
- Drug-Free: 100% correct (327/327)
- Less than Half the Cutoff: 100% correct (27/27)
- Near Cutoff Negative: 100% correct (7/7)
- Near Cutoff Positive: 67% correct (6/9)
- High Positive: 100% correct (3/3)
- Methamphetamine:
3. Clinical Studies: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as Sensitivity, Specificity, PPV, NPV. The performance is reported as "The percentage of correct results" and discordant results.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo is in blue and reads "FDA U.S. FOOD & DRUG ADMINISTRATION".
February 2, 2018
Premier Biotech Inc % Lisa Pritchard Regulatory, Quality & Compliance Consultant DuVal & Associates 1820 Medical Arts Building, 825 Nicollet Mall Minneapolis, MN, 55402
Re: K171403
Trade/Device Name: OralTox Oral Fluid Drug Test Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC, DIO, DJG, LCM, LDJ, DKZ Dated: January 4, 2018 Received: January 5, 2018
Dear Lisa Pritchard:
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, listing 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Courtney HLias -S
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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Indications for Use
510(k) Number (if known) K171403
Device Name OralTox Oral Fluid Drug Test
Indications for Use (Describe)
The Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9 Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 40 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
- February 1, 2018 1. Date:
-
- Submitter: Premier Biotech Inc 723 Kasota Avenue SE, Minneapolis MN 55414
-
- Contact person: Jackie Gale Premier Biotech Inc 723 Kasota Avenue SE, Minneapolis MN 55414 Telephone: 612-839-5563 Email: jgale@premierbiotech.com
-
- Device Name: OralTox Oral fluid Drug Test
Classification:
| Product Code | CFR # | Panel |
|---|---|---|
| DJC | 21 CFR, 862.3610 Methamphetamine Test System | Toxicology |
| DIO | 21 CFR, 862.3250 Cocaine Test System | Toxicology |
| DJG | 21 CFR, 862.3650 Opiate Test System | Toxicology |
| DKZ | 21 CFR, 862.3100 Amphetamine Test System | Toxicology |
| LCM | Enzyme Immunoassay Phencyclidine Test System | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoids Test System | Toxicology |
-
- Predicate Devices: K103227
The Oratect Oral Fluid Drug Screen Device
- Predicate Devices: K103227
6. Intended Use
The OralTox™ Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates and Phencyclidine, in human oral fluid at the cutoff concentrations listed below and their metabolites:
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9 -Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 40 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
The test provides only preliminary test results. A more specific alternative chemical method must be
4
used in order to obtain a confirmed analytical result. Liquid Chromatography/Mass Spectrometry, Mass Spectrometry (LC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only.
-
- Device Description
The OralTox Oral fluid Drug Test is immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Opiates and Phencyclidine (target analytes) in human oral fluid. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the OralTox Oral fluid Drug Test and the predicate devices is provided in following tables.
- Substantial Equivalence Information
Table 1: Features Comparison of OralTox Oral fluid Drug Test and the Predicate Devices
| Item | Device | Predicate - K103227 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of drugs of | |
| abuse in human oral fluid. | Same | |
| Calibrators | D-Amphetamine | |
| Cocaine | ||
| Delta-9-Tetrahydrocannabinol | ||
| D-Methamphetamine | ||
| Morphine | ||
| Phencyclidine | Same | |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based on the | ||
| principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Oral fluid | Same |
| Cut-Off Values | AMP 50 ng/mL | |
| COC 20 ng/mL | ||
| THC 40 ng/mL | ||
| MET 50 ng/mL | ||
| MOP 40 ng/mL | ||
| PCP 10 ng/mL | Same |
5
| Intended Use | For prescription uses. | Same |
|---|---|---|
| Configurations | Cups | Testing Pad |
9. Test Principle
The OralTox Salvia Drug Test is rapid test for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine and Phencyclidine in oral fluid samples. The tests are lateral flow chromatographic immunoassays. During testing, an oral fluid specimen migrates upward by capillary action. If target drugs present in the oral fluid specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoffconcentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
10. Performance Characteristics
1. Analytical Performance
- a. Precision-Reproducibility-Cut-Off
Precision-Reproducibility-Cut-Off studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative oral fluid samples. Each drug concentration was confirmed by LC/MS/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 10 days per device lot in a randomized order. The following are summaries.
| Amphetamine | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| drug | Result | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50%cut off | +75%cut off | +100%cut off |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 53+/7- | 55+/5- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 51+/9- | 55+/5- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 56-/4+ | 49+/11- | 54+/6- | 60+/0- | 60+/0- | 60+/0- |
| Cocaine | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| drug | Result | -100%cut off | -75%cut off | -50%cut off | -25% cutoff | cut off | +25%cut off | +50%cut off | +75%cut off | +100%cut off |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 56-/4+ | 52+/8- | 54+/6- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 50+/10- | 54+/6- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Methamphetamine | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| drug | Result | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50%cut off | +75%cut off | +100%cut off |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 50+/10- | 55+/5- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 49+/11- | 56+/4- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
Morphine
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| drug | Result -100%cut -75%cut -50%cut
off | off | off | -25%
cutoff | cut off | off | off | off | +25%cut +50%cut +75%cut +100%cut
off |
|-------|-----------------------------------------|--------|--------|----------------|---------|--------|--------|--------|-----------------------------------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | રહ્યાર્ટન | 48+/12- | 57+/3- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-10+ | રહ્યાર્ટન | 48+/12- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-10+ | 60-/0+ | 60-10+ | 54-/6+ | 50+/10- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Phencyclidine | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| drug | Result | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75%cut off | +100% cut off |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- | |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Cannabinoids | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| drug | Result | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50%cut off | +75%cut off | +100%cut off |
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 50+/10- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 50+/10- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| d-Methamphetamine | 50 |
| Cocaine | 20 |
| Morphine | 40 |
| d-Amphetamine | 50 |
| Phencyclidine | 10 |
| Delta-9-Tetrahydrocannabinol | 40 |
b. Linearity
Not applicable.
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C.
d. Interference
Potential interfering substances were added to drug-free oral fluid and target drugs oral fluid with concentrations at 50% below and 50% above Cut-Off levels. These oral fluid samples were tested using three batches of the OralTox device. Compounds that showed no interference for all the six drugs at a concentration of 10μg/mL are summarized in the following table.
| Acetaminophen | Digoxin | Nicotinamide |
|---|---|---|
| Acetylcodeine | Dihydrocodeine | Nicotine |
| Allobarbital | diltiazem HCl | Noscapine |
| Alprazolam | Diphenhydramine HCl | Omeprazole |
| Amobarbital | DL-Propranolol | Papaverine |
| Apomorphine | Doxylamine | Pentazocine |
| Atenolol | Ecgonine methylester | Phentermine |
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| Atropine | Estradiol | Phenylpropanolamine |
|---|---|---|
| Baclofen | Estrone | Phenytoin |
| Benzocaine | Fluconazole | Pioglitazone HCl |
| Butabarbital | Furosemide | Prednisolone |
| Caffeine | Hexobarbital | Prednisone |
| Cannabidiol | Hydrochlorothiazide | Procainamide HCl |
| Carbamazepine | Ibuprofen | Procaine HCL |
| Chlordiazepoxide | Imipramine | Promethazine |
| Chlorpromazine | Lamotrigine | Quinine HCl |
| Cimetidine | Levetiracetam | R,R(-)-Pseudoephedrine |
| Citalopram HBr | Lidocaine | Salicylic Acid |
| Clobazam | Lormetazepam | Sertraline HCL |
| Clomipramine | L-Thyroxine | Simvastin |
| Clonazepam | Metformin HCl | Theophylline |
| Clonidine | Methylphenidate HCl | Thiamine |
| Clopidogrel bisulfate | Metoprolol | Topiramate |
| Cortisol | Metronidazole | Valproic Acid |
| Cotinine | Montelukast sodium salt | Verapamil |
| d,l-Salbutamol | Naloxone | Zonisamide |
| Deoxycorticosterone | Naltrexone | |
| Dextromethorphan | Naproxen |
Food items such as methanol cough drops, cough syrup, cola, mouthwash, coffee, tea, milk, sugar, chewing gum, alcohol, baking soda, salt, cranberry juice, orange juice, food coloring (red, blue, green), toothpaste, tomatoes and MSG were added in either drug-free oral fluid or oral fluid containing the target drug with concentrations of 50% below and 50% above cutoff levels to a concentration of 5%. None of the substances showed interference.
Hemoglobin showed no interference at 100 µg/mL.
Cigarette smoking showed no interference.
e. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in oral fluid samples were tested using three batches of the OralTox device. The following are summaries.
| d-Methamphetamine | Result | % Cross-Reactivity |
|---|---|---|
| (Cut-off=50 ng/mL) | Positive at (ng/mL) | |
| D - Methamphetamine | 50 | 100% |
| L - Methamphetamine | 5000 | 1% |
| Methoxymethamphetamine | 50 | 100% |
| Ephedrine | 250 | 20% |
| Phenylephrine | 1250 | 4% |
| Procaine | 2500 | 2% |
| Methylephedrine | 500 | 10% |
| Methylenedioxyethylamphetamine | 500 | 10% |
| 3,4-methylenedioxy-methamphetamine | ||
| (MDMA) | 100 | 50% |
8
| Amphetamine | 100000 | 0.05% |
|---|---|---|
| L-Amphetamine | Negative at 10000 | $ |