(126 days)
No
The device description and performance studies describe a standard immunochromatographic assay (lateral flow test) for drug detection, with no mention of AI or ML components for analysis or interpretation.
No
The device is described as an "in vitro diagnostic device" designed for the qualitative detection of specific drugs in human oral fluid. Its purpose is to provide "preliminary test results" for drug presence, not to treat or prevent a disease or condition.
Yes
Explanation: The "Device Description" explicitly states that the products are "single-use in vitro diagnostic devices." Furthermore, its "Intended Use" is for the "qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid," which is clearly a diagnostic purpose.
No
The device description clearly states it is an immunochromatographic assay using a lateral flow system and includes physical components like a test cup, sample collection sponge, and test device sealed in an aluminum pouch. This indicates it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone in human oral fluid". This is a diagnostic purpose, analyzing a human sample to detect specific substances.
- Device Description: The device description clearly states, "The products are single-use in vitro diagnostic devices." This is a direct declaration that the device falls under the category of IVDs.
- Anatomical Site: The test is performed on "human oral fluid," which is a biological sample taken from the human body.
- Performance Studies: The document describes performance studies involving testing human samples and comparing results to a reference method (LC/MS/MS), which is typical for validating IVD performance.
- Predicate Device: The mention of a predicate device (K171403: OralTox Oral Fluid Drug Test) and reference devices (K002010, K122809) further indicates that this device is being compared to other devices already classified as IVDs.
All these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone 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 | 50 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Methadone (MTD) | Methadone | 30 |
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/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.
Product codes (comma separated list FDA assigned to the subject device)
DJC, DJG, DIG, DIO, DKZ, LCM, LDJ, DJR
Device Description
The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human oral fluid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
- Precision-Reproducibility-Cut-Off: Studies carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples were prepared by spiking drug in negative oral fluid samples, and concentrations were confirmed by LC/MS/MS. For each concentration, tests were performed two runs per day for 10 days per device lot in a randomized order.
- Methadone results summary:
- Lot 1: 60-/0+ at -100%, -75%, -50% cut-off; 54-/6+ at -25% cut-off; 49+/11- at cut-off; 55+/5- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Lot 2: 60-/0+ at -100%, -75%, -50% cut-off; 55-/5+ at -25% cut-off; 48+/12- at cut-off; 56+/4- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Lot 3: 60-/0+ at -100%, -75%, -50% cut-off; 55-/5+ at -25% cut-off; 50+/10- at cut-off; 55+/5- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Oxycodone results summary:
- Lot 1: 60-/0+ at -100%, -75%, -50% cut-off; 55-/5+ at -25% cut-off; 50+/10- at cut-off; 55+/5- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Lot 2: 60-/0+ at -100%, -75%, -50% cut-off; 54-/6+ at -25% cut-off; 49+/11- at cut-off; 56+/4- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Lot 3: 60-/0+ at -100%, -75%, -50% cut-off; 56-/4+ at -25% cut-off; 49+/11- at cut-off; 57+/3- at +25% cut-off; 60+/0- at +50%, +75%, +100% cut-off.
- Methadone results summary:
- Linearity: Not applicable.
- Stability: Devices are stable at 4-30 °C for 24 months based on accelerated stability study at 45 ℃ and real time stability study at 2-8℃ and 30℃.
- Interference: Potential interfering substances (various pharmaceuticals, food items, hemoglobin, cigarette smoking) were tested at 10μg/mL or 5% concentration. No interference was observed for all eight drugs.
- Specificity: Tested using drug metabolites and other structural related compounds.
- Oxycodone (Cut-off=20 ng/mL): Oxycodone (100%), Hydrocodone (2%), Hydromorphone (0.3%), Naloxone (0.3%), Oxymorphone (2%). Others like Dihydrocodeine, Buprenorphine, 6-AM, Codeine, Heroin, Morphine, Morphine -3-β-d-glucuronide, Ethylmorphine showed
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 20, 2018
Premier Biotech, Inc. c/o Lisa Pritchard Regulatory, Quality & Compliance Consultant DuVal & Associates 825 Nicollet Mall Suite 1820 Minneapolis, MN 55402
Re: K181305
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, DJG, DIG, DIO, DKZ, LCM, LDJ, DJR Dated: August 9, 2018 Received: August 10, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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.
Kellie B. Kelm -S
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
2
Indications for Use
510(k) Number (if known) K181305
Device Name OralTox® Oral fluid Drug Test
Indications for Use (Describe)
The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine, Opiates, Phencyclidine, Oxycodone and Methadone 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 | 50 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Methadone (MTD) | Methadone | 30 |
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/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result. particularly when the preliminary result is positive.
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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3
K181305 510(k) SUMMARY
- September 19, 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: 612-839-5565 Email: jgale@premierbiotech.com
- OralTox® Oral fluid Drug Test 4. Device Name:
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 | Toxicology |
| LDJ | 21 CFR, 862.3870 Cannabinoids Test System | Toxicology |
| DJR | 21 CFR, 862.3610 Methadone Test System | Toxicology |
5. Predicate Devices:
Predicate Device K171403: OralTox Oral Fluid Drug Test
Reference Devices K002010: OraSure Methadone Intercept Micro-plate K122809: Advin Multi-Drug Screen Test Cup
-
- Intended Use
The OralTox® Oral Fluid Drug Test is a competitive binding, lateral flow immunochromatographic assay for the qualitative and simultaneous detection of Amphetamine, Cocaine, Marijuana (THC), Methamphetamine. Opiates, Phencyclidine. Oxycodone and Methadone in human oral fluid at the cutoff concentrations listed below and their metabolites:
- Intended Use
4
| Test | Calibrator | Cutoff (ng/mL) |
|---|---|---|
| Amphetamine (AMP) | d-Amphetamine | 50 |
| Cocaine (COC) | Benzoylecgonine | 20 |
| Marijuana (THC) | Delta-9-Tetrahydrocannabinol | 40 |
| Methamphetamine (MET) | d-Methamphetamine | 50 |
| Opiates (OPI) | Morphine | 40 |
| Phencyclidine (PCP) | Phencyclidine | 10 |
| Oxycodone (OXY) | Oxycodone | 20 |
| Methadone (MTD) | Methadone | 30 |
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/ Mass Spectrometry (LC-MS/MS) is the preferred confirmatory method. It is not intended to detect intermittent dosing of Oxycodone. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
7. Device Description
The OralTox Oral fluid Drug Test is an immunochromatographic assay that uses a lateral flow system for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine. Oxycodone and Methadone (target analytes) in human oral fluid. The products are single-use in vitro diagnostic devices. Each test kit contains a test cup, a package insert and a sample collection sponge. Each test device is sealed with a desiccant in an aluminum pouch.
-
- 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 and Reference Devices
| Item | Subject Device | Predicate Device K171403 |
|---|---|---|
| Intended | ||
| Use | For the qualitative determination of | |
| drugs of abuse in human oral fluid. | Same | |
| Item | Subject Device | Predicate Device K171403 |
| Calibrators | D-Amphetamine (AMP) | |
| Cocaine (COC) | ||
| Delta-9-Tetrahydrocannabinol (THC) | ||
| D-Methamphetamine (MET) | ||
| Morphine (OPI) | ||
| Phencyclidine (PCP) | ||
| Oxycodone (OXY) | ||
| Methadone (MTD) | D-Amphetamine (AMP) | |
| Cocaine (COC) | ||
| Delta-9-Tetrahydrocannabinol | ||
| (THC) | ||
| D-Methamphetamine (MET) | ||
| Morphine (OPI) | ||
| Phencyclidine (PCP) | ||
| 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 | ||
| OPI 40 ng/mL | ||
| PCP 10 ng/mL | ||
| OXY 20 ng/mL | ||
| MTD 30 ng/mL | Same, except OXY and MTD not | |
| included |
5
9. Test Principle
The OralTox Oral Fluid Drug Test is a rapid test for the qualitative detection of Amphetamine, Cocaine, Cannabinoids, Methamphetamine, Morphine, Phencyclidine, Oxycodone and Methadone 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 cutoff-concentration because it will saturate all the binding sites of the antibody coated on the
6
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
-
- Analytical Performance
- Precision-Reproducibility-Cut-Off a.
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, +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 results obtained are summarized in the following tables for Methadone and Oxycodone. The rest of the data were reported in K171403.
The results summary for methadone
| | Result | -100%
cut-off | -75%
cut-off | -50%
cut-off | -25%
cut-off | Cut-off | +25%
cut-off | +50%
cut-off | +75%
cut-off | +100%
cut-off |
|------|--------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| drug | Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 49+/11- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| | Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 48+/12- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| | Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 50+/10- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| 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
ut off |
|-------|--------|------------------|-----------------|-----------------|----------------|---------|-----------------|----------------|----------------|--------------------|
| Lot 1 | | 60-/0+ | 60-/0+ | 60-/0+ | 55-/5+ | 50+/10- | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | | 60-/0+ | 60-/0+ | 60-/0+ | 54-/6+ | 49+/11- | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | | 60-/0+ | 60-/0+ | 60-/0+ | 56-/4+ | 49+/11- | 57+/3- | 60+/0- | 60+/0- | 60+/0- |
The results summary for oxycodone
The following cut-off values for the candidate device have been verified.
| Calibrator | Cut-off (ng/mL) |
|---|---|
| Methadone | 30 |
| Oxycodone | 20 |
-
b. Linearity
Not applicable. -
c. Stability
The devices are stable at 4-30 °C for 24 months based on the accelerated stability study at 45 ℃ and real time stability study at 2-8℃ and 30℃.
7
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 eight 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 |
| 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,1-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 ug/mL.
Cigarette smoking showed no interference.
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e. Specificity
To test specificity, drug metabolites and other structural related compounds that are likely to interfere in oral fluid samples were tested using three batches of the OralTox device. The results obtained are summarized in the following tables for Methadone and Oxycodone. The rest of the data were reported in K171403.
| Oxycodone
(Cut-off=20 ng/mL) | Result
Positive at (ng/mL) | % Cross-Reactivity |
|---------------------------------|-------------------------------|--------------------|
| Oxycodone | 20 | 100% |
| Hydrocodone | 1000 | 2% |
| Hydromorphone | 6250 | 0.3% |
| Naloxone | 6250 | 0.3% |
| Oxymorphone | 1000 | 2% |
| Dihydrocodeine | Negative at 10000 |