Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx
Device Facts
| Record ID | K221871 |
|---|---|
| Device Name | Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx |
| Applicant | Healstone Biotech, Inc. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Aug 30, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. For in vitro diagnostic use only.
Device Story
Rapid, single-use, lateral flow chromatographic immunoassay for qualitative detection of drugs of abuse in human urine. Urine sample absorbed into test strip; migrates via capillary action. Competitive binding principle: target drug below cutoff level allows antibody-coated particles to bind immobilized drug-conjugate, forming visible colored test line; drug above cutoff saturates binding sites, preventing test line formation. Control line forms regardless of drug presence. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires confirmation by GC/MS. Benefits patient by enabling rapid, point-of-care screening for potential drug abuse.
Clinical Evidence
Bench testing only. Performance validated via precision studies (25 days, 3 lots), interference testing (100+ compounds), specificity/cross-reactivity, and method comparison against LC/MS or GC/MS. Method comparison study included 80 samples per analyte. Lay-user study (n=280) confirmed ease of use and performance across diverse educational backgrounds.
Technological Characteristics
Lateral flow chromatographic immunoassay. Single-use test cup. Analyte-specific monoclonal antibody-coated particles. Competitive binding principle. No electronic components or external energy source. Stable at 2-30°C for 24 months.
Indications for Use
Indicated for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methamphetamine, Methylenedioxymethamphetamine (MDMA), Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, and Cannabinoids in human urine. Intended for both over-the-counter and prescription use.
Regulatory Classification
Identification
An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An amphetamine 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).
Related Devices
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- K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup · Assure Tech., LLC · Feb 7, 2025
- K180878 — BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx · Shanghai Venture Bio-Tech Co., Ltd. · Dec 17, 2018
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
August 30, 2022
Healstone Biotech Inc % Joe Shia Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877
## Re: K221871
Trade/Device Name: Healstone Accurate™ Drug of Abuse Urine Test Cup, Healstone Accurate™ Drug of Abuse Urine Test Cup Rx Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Code: NFT, NGL, PTH, NFV, NFY, PTG, QBF, NGG, QAW, NFW, NGM Dated: June 26, 2022 Received: June 28, 2022
Dear Joe Shia:
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.
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
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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula Caposino, Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known)
#### K221871
Device Name
Healstone Accurate™ Drug of Abuse Urine Test Cup
Indications for Use (Describe)
The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF<br>(ng/mL) |
|----------|---------------------------------------------------------|--------------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI/MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
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The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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# Indications for Use
510(k) Number (if known)
#### K221871
#### Device Name
Healstone Accurate™Drug of Abuse Urine Test Cup Rx
#### Indications for Use (Describe)
The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF<br>(ng/mL) |
|----------|---------------------------------------------------------|--------------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI/MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This drug tests cup provides only a preliminary result. An alternative laboratory test must be results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
{5}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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- Date August 30, 2022 1 Healstone Biotech Inc. 2 Submitter 655 W Kent Ave N #650 Vancouver, BC V6P 6T7, Canada
- Contact Person Joe Shia 3 LSI International Inc. 504 East Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: 240-505-7880 Fax: 301-916-6213 Email: shiajl@yahoo.com
- Healstone Accurate™ Drug of Abuse Urine Test Cup 4 Device Name Healstone Accurate™ Drug of Abuse Urine Test Cup Rx
- 5 Classification Class II
| Product Code | Regulation Section | Cup |
|----------------------------------------------------------------------------|------------------------------------------|------------|
| Target Drug | | |
| NFT<br>Amphetamine (AMP) | 862.3100, Amphetamine Test<br>System | Toxicology |
| NGL<br>Buprenorphine (BUP) | 862.3650, Opiate Test System | Toxicology |
| PTH<br>Secobarbital (BAR) | 862.3150, Barbiturate Test<br>System | Toxicology |
| NFV<br>Oxazepam (BZO) | 862.3170,<br>Benzodiazepine Test System | Toxicology |
| NFY<br>Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG<br>2-ethylidene-1,5-<br>dimethyl-3,3-<br>diphenylpyrrolidine<br>(EDDP) | 862.3620, Methadone Test System | Toxicology |
| NGG<br>Methamphetamine<br>(MET) | 862.3610,<br>Methamphetamine Test System | Toxicology |
| NGG<br>Methylenedioxymethamphetamine (MDMA) | 862.3610,<br>Methamphetamine Test System | Toxicology |
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| NGL | 862.3650, Opiate Test System | Toxicology |
|-----------------------|-----------------------------------|------------|
| Morphine (MOP/OPI) | | |
| PTG | 862.3620, Methadone Test System | Toxicology |
| Methadone (MTD) | | |
| NGL | 862.3650, Opiate Test System | Toxicology |
| Oxycodone (OXY) | | |
| NGM | Unclassified, Enzyme | Toxicology |
| Phencyclidine (PCP) | Immunoassay Phencyclidine | |
| QBF | 862.3700 Propoxyphene test | Toxicology |
| Propoxyphene (PPX) | system. | |
| QAW | 862.3910 Tricyclic antidepressant | Toxicology |
| Nortriptyline (TCA) | drugs test system | |
| NFW | 862.3870, Cannabinoids Test | Toxicology |
| Cannabinoids (THC 50) | System | |
#### Predicate Device K191841 6.
Healstone Accurate™ Multi Panel Drug Urine Test Cup
### 7. Intended Use
The Healstone Accurate TM Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|-----------|---------------------------------------------------------|-----------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI / MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
This drug test cup may contain any combination of the drug tests listed in the table above.
This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test.
For in vitro diagnostic use only.
The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay.
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The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|----------|---------------------------------------------------------|-----------------|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | 2-ethylidene-1, 5-dimethyl-3, 3-<br>diphenylpyrrolidine | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | 3,4-methylenedioxy-methamphetamine | 500 |
| OPI/MOP | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.
#### Device Description 8.
The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.
#### 9. Substantial Equivalence Information
| Item | Proposed Device | Predicate<br>(K191841) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Indication(s) for<br>use | For the qualitative determination of Amphetamine,<br>Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-<br>1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine,<br>Methylenedioxymethamphetamine, Morphine, Methadone,<br>Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and<br>Cannabinoids in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay<br>based on antigen-antibody reaction | Same |
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| Type of Test | Qualitative | Same | |
|-----------------------------------|--------------------------------------------------------------|----------------|-----------------------------|
| Specimen Type | Human urine | Same | |
| Target Drug and<br>Cut Off Values | Target Drug | Cutoff (ng/mL) | Same except that |
| | Amphetamine (AMP) | 1000 or 500 | AMP and MET have |
| | Buprenorphine (BUP) | 10 | no 500 cutoff, and |
| | Secobarbital (BAR) | 300 | COC has no 150 |
| | Oxazepam (BZO) | 300 | cutoff. |
| | Cocaine (COC) | 300 or 150 | |
| | 2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine (EDDP) | 300 | |
| | Methamphetamine (MET) | 1000 or 500 | |
| | Methylenedioxymethamphetamine (MDMA) | 500 | |
| | Morphine (MOP 300/OPI 2000) | 2000 or 300 | |
| | Methadone (MTD) | 300 | |
| | Oxycodone (OXY) | 100 | |
| | Phencyclidine (PCP) | 25 | |
| | Propoxyphene (PPX) | 300 | |
| | Nortriptyline (TCA) | 1000 | |
| | Cannabinoids (THC 50) | 50 | |
| Configurations | Test Cup | | Cup |
| Intended Use | Prescription Use and over-the-counter use | | For over-the-counter<br>use |
## 10. Test Principle
Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid tests for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine,Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Cannabinoids in urine samples. They are lateral flow chromatographic immunoassay. When urine sample is added to the cup device, urine is absorbed into the test strip and migrates upwards by capillary action. If the concentration of target drug presented in the urine sample is below the cutoff level, the target drug will not saturate the binding sites of its specific monoclonal antibody-coated particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored band will be formed on the test line region. If the concentration of target is beyond the cutoff level, the target drug will saturate the binding sites of its specific monoclonal antibody-particles, thus the antibody-coated particles will not be captured by immobilized drug-conjugate hence no colored band will be formed on the test line region.
A band should be formed on the control line region regardless of the presence of target drug or metabolite in the sample to indicate that the tests have been performed properly.
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## 11. Performance Characteristics
## 1. Analytical Performance
#### Precision a.
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cutoff, +25% cut off, +50% cut off, +75% cut off and +100% cut off. Samples with concentration of -100% cutoff were drug-free urines samples. Other samples were prepared by spiking target drug in drug-free urine samples. Each drug concentration was confirmed by LC/MS or GC/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test Cups. The results obtained are summarized in the following tables:
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| 0 | 2.4 | 5.1 | 7.5 | 10.2 | 12.3 | 14.8 | 17.6 | 19.6 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 27-/23+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup BUP 10
## Accurate™ Drug of Abuse Urine Test Cup PCP 25
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 5.8 | 11.9 | 18.7 | 25.2 | 32.0 | 38.7 | 43.1 | 50.8 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
## Accurate™ Drug of Abuse Urine Test Cup THC 50
| Concentration | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| (ng/mL) | 0 | 12.4 | 26.9 | 39.3 | 53.5 | 64.5 | 77.7 | 89.6 | 102.4 |
| Lot Number | | | | | | | | | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
## Accurate™ Drug of Abuse Urine Test Cup OXY 100
| Concentration | -100% | -75% | -50% | -25% | cut off | +25% | +50% | +75% | +100% |
|---------------|-------|------|------|------|---------|------|------|------|-------|
|---------------|-------|------|------|------|---------|------|------|------|-------|
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| (ng/mL) | cut off | cut off | cut off | cutoff | cut off | cut off | cut off | cut off | cut off |
|------------|---------|---------|---------|--------|---------|---------|---------|---------|---------|
| Lot Number | 0 | 26.8 | 49.2 | 81.1 | 101.5 | 131.6 | 153.4 | 174.1 | 192.0 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 27-/23+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup BAR 300
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 78.2 | 145.0 | 230.9 | 316.6 | 382.5 | 455.2 | 533.0 | 587.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 21-/29+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup BZO 300
| Concentration<br>(ng/mL) | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 76.6 | 148.6 | 222.9 | 300.0 | 374.3 | 455.7 | 516.0 | 598.6 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup EDDP 300
| Concentration<br>(ng/mL) | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 72.4 | 149.2 | 233.2 | 312.4 | 385.2 | 451.2 | 522.0 | 599.0 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup MTD 300
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 73.7 | 156.5 | 229.9 | 314.4 | 365.1 | 456.9 | 521.2 | 590.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
{12}------------------------------------------------
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
|-------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup MOP 300
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 69.1 | 148.2 | 228.7 | 302.0 | 382.1 | 445.0 | 509.1 | 583.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup PPX 300
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 73.0 | 160.0 | 236.0 | 320.7 | 384.7 | 458.7 | 538.6 | 579.9 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup COC 150
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 21-/29+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup MDMA 500
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off | |
|----------------------------------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|--------|
| 0 | 122.9 | 272.8 | 370.6 | 499.5 | 628.4 | 752.1 | 870.4 | 935.7 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 21-/29+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23-/27+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
{13}------------------------------------------------
## Accurate™ Drug of Abuse Urine Test Cup TCA 1000
| Concentration<br>(ng/mL) | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot Number | 0 | 248.7 | 489.5 | 758.2 | 988.3 | 1288.6 | 1536.5 | 1701.3 | 1958.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup AMP 500
| Concentration<br>(ng/mL) | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|--------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | Lot Number | 0 | 123.4 | 267.8 | 354.5 | 498.5 | 630.4 | 716.0 | 850.7 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 24-/26+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 25-/25+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup MET 500
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 128.8 | 262.7 | 365.1 | 512.9 | 680.8 | 790.4 | 909.2 | 1021.3 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 26-/24+ | 48+/2- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25-/25+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup OPI 2000
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| 0 | 535.8 | 1070.4 | 1636.6 | 2122.3 | 2632.6 | 3014.8 | 3337.5 | 3762.8 | |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup COC 300
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 79.9 | 159.9 | 229.9 | 301.1 | 380.2 | 463.4 | 529.1 | 593.2 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
{14}------------------------------------------------
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 22-/28+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
|-------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 49-/1+ | 24-/26+ | 49+/1- | 50+/0- | 50+/0- | 50+/0- |
Accurate™ Drug of Abuse Urine Test Cup AMP 1000
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off<br>0 | -75%<br>cut off<br>235.8 | -50%<br>cut off<br>525.0 | -25%<br>cutoff<br>785.9 | cut off<br>1086.6 | +25%<br>cut off<br>1315.3 | +50%<br>cut off<br>1599.2 | +75%<br>cut off<br>1816.7 | +100%<br>cut off<br>2040.5 |
|----------------------------------------|-----------------------|--------------------------|--------------------------|-------------------------|-------------------|---------------------------|---------------------------|---------------------------|----------------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Accurate™ Drug of Abuse Urine Test Cup MET 1000
| Concentration<br>(ng/mL)<br>Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cutoff | cut off | +25%<br>cut off | +50%<br>cut off | +75%<br>cut off | +100%<br>cut off |
|----------------------------------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 252.5 | 512.2 | 767.2 | 1021.9 | 1251.6 | 1496.4 | 1781.4 | 2005.1 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The following cutoff values are verified:
| Target Drug | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL or 500 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL or 500 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (OPI 2000/MOP 300) | 2000 ng/mL or 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC 50) | 50 ng/mL |
{15}------------------------------------------------
## b. Linearity
Not applicable
- c. Stability
The devices are stable at 2-30℃ for 24 months based on real-time stability studies.
- d. Interference
Potential interfering substances were added to drug-free urine samples with target drugs of -50% cutoff and +50% cutoff level.
Compounds that show no interference at a concentration of 100μg/mL are summarized in the following table.
| (-) Cotinine | Diphenhydramine HCl | Noscapine |
|--------------------------|-----------------------|------------------------|
| (±)-4-Methylephedrine-D3 | D,L-Propranolol | O-Hydroxyhippuric acid |
| 3-Hydroxytyramine | D,L-Tyrosine | Olanzapine |
| Acetaminophen | Doxylamine | Oxalic acid |
| Acetophenetidin | D-Pseudoephedrine | Oxolinic acid |
| Acetylsalicylic acid | Ecgonine methyl ester | Oxymetazoline |
| Albumin(100mg/dL) | EMDP | Papaverine |
| Alpha Methadol | Erythromycin | Penicillin-G |
| Aminopyrine | Ethanol (1%) | Perphenazine |
| Amoxicillin | Fenoprofen | Phenacetin |
| Ampicillin | Furosemide | Phenelzine |
| Apomorphine | Gabapentin | Phenethylamine |
| Ascorbic acid | Gatifloxacin | Phenylpropanolamine |
| Aspartame | Gentisic acid | Prednisone |
| Aspirin | Glucose | Procaine |
| Atropine | Hemoglobin | Promethazine |
| Azithromycin | Hydralazine | Quetiapine |
| Benzilic acid | Hydrochlorothiazide | Quinine |
| Benzoic acid | Hydrocortisone | Ranitidine |
| Benzphetamine | Ibuprofen | Salicylic acid |
| Bilirubin | Isoxsuprine | Serotonin |
{16}------------------------------------------------
| Cannabidiol | Ketamine | Serotonin (5- Hydroxytyramine) |
|---------------------|----------------------|----------------------------------------|
| Carfentanil | Ketoprofen | Sertraline |
| Chloralhydrate | LAAM HCl | Sulfamethazine |
| Chloramphenicol | Labetalol | Sulindac |
| Chloroquine | L-Ephedrine | Telmisartan |
| Chlorothiazide | L-Epinephrine | Tetrahydrocortisone 3-(β-Dglucuronide) |
| Chlorpromazine | Loperamide | Tetrahydrocortisone, 3-acetate |
| Cholesterol | Loratadine | Tetrahydrozoline |
| Clonidine | L-phenylephrine | Thiamine |
| Cortisone | Magnesium | Thioridazine |
| Creatinine | Maprotiline | Triamterene |
| D,L-Tryptophan | Meperidine | Trifluoperazine |
| D,L-Isoproterenol | Meprobamate | Trimethobenzamide |
| D,L-Octopamine | Methoxyphenamine | Trimethoprim |
| D,L-Epinephrine | N-Acetylprocainamide | Uric acid |
| Delorazepam | Nalidixic acid | Verapamil |
| Deoxycorticosterone | Naproxen | Vitamin B2 |
| Desloratadine | Niacinamide | Vitamin C |
| Dextromethorphan | Nicotine | Zaleplon |
| Diclofenac | Nifedipine | Zomepirac |
| Diclofenac sodium | Nordoxepin | β-Estradiol |
| Diflunisal | Norethindrone | |
| Digoxin | Norfentanyl | |
- e. Specificity
To test the specificity, drug metabolites and other components that are likely to cross-react in urine samples were spiked into drug-free urine. These urine samples were tested using three lots of each device.
Percent cross-reactivity, provided in the below table, was calculated by dividing the cutoff concentration by the minimum concentration required to obtain a positive result, multiplied by 100; compounds that did not yield a positive result at the highest concentration tested have relative cross reactivity results represented by a dash in the table below:
{17}------------------------------------------------
| BUP 10 (Buprenorphine,<br>Cutoff=10 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine -3-D-Glucuronide | 160 | 6.25% |
| Norbuprenorphine | 10 | 100% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100,000 | - |
| Oxymorphone | >100,000 | -- |
| Hydromorphone | >100,000 | -- |
| PCP (Phencyclidine)<br>(Phencyclidine,<br>Cutoff=25 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 4-Hydroxyphencyclidine | 12500 | 0.2% |
| THC 50<br>(11-nor-Δ9-THC-9-COOH,<br>Cutoff=50 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 11-nor-Δ8-THC 50-9-COOH | 30 | 167% |
| (-)-11-nor-9-carboxy-Δ 9-THC 50 | 50 | 100% |
| 11-nor-Δ9-THC 50-carboxy glucuronide | 100 | 50% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5000 | 1% |
| Δ8- Tetrahydrocannabinol | 1300 | 3.8% |
| Δ9- Tetrahydrocannabinol | 5000 | 1% |
| Cannabinol | 20000 | 0.25% |
| Cannabidiol | >100000 | -- |
| OXY 100<br>(Oxycodone, Cutoff=100 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Ethyl Oxycodone | 75,000 | 0.13% |
| Hydrocodone | 5,000 | 2% |
| Hydromorphone | 25,000 | 0.4% |
| Levorphanol tartrate | 25,000 | 0.4% |
| Naloxone hydrochloride | 10,000 | 1% |
| Naltrexone hydrochloride | 50,000 | 0.2% |
| Oxymorphone | 200 | 50% |
| Oxymorphone-D3 | 200 | 50% |
| Dihydrocodeine | >100,000 | -- |
| Codeine | >100,000 | -- |
| Morphine | >100,000 | -- |
| Acetylmorphine | >100,000 | -- |
{18}------------------------------------------------
| Buprenorphine | >100,000 | -- |
|---------------|----------|----|
| Ethylmorphine | >100,000 | -- |
| Thebaine | >100,000 | -- |
| COC 150<br>(Benzoylecgonine, Cutoff=150 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Cocaethylene | 150 | 100% |
| Cocaine HCl | 150 | 100% |
| Ecgonine | 25,000 | 0.6% |
| Norcocaine | 50,000 | 0.3% |
| Ecgonine methyl Ester | >100000 | -- |
| BAR 300<br>(Secobarbital, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alphenal | 150 | 200% |
| Amobarbital | 300 | 100% |
| Aprobarbital | 250 | 120% |
| Butabarbital | 2,500 | 12% |
| Butethal | 100 | 300% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 250 | 120% |
| Phenobarbital | 250 | 120% |
| Butalbital | 2,500 | 12% |
| BZO 300<br>(Oxazepam, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| a-Hydroxyalprazolam | 1,260 | 23.8% |
| Alprazolam | 200 | 150% |
| Bromazepam | 1,560 | 19.2% |
| Chlordiazepoxide | 1,560 | 19.2% |
| Clobazam | 100 | 300% |
| Clonazepam | 2,500 | 12% |
| Clorazepate Dipotassium | 200 | 150% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2,500 | 12% |
| Flunitrazepam | 400 | 75% |
| D,L-Lorazepam | 1,560 | 19.2% |
| Midazolam | 12,500 | 2.4% |
{19}------------------------------------------------
| Nitrazepam | 100 | 300% |
|---------------------------|----------|--------|
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 400 | 75% |
| R,S-Lorazepam glucuronide | 160 | 187.5% |
| Temazepam | 100 | 300% |
| Triazolam | 2,500 | 12% |
| Demoxepam | 2,000 | 15% |
| Flurazepam | 500 | 60% |
| Delorazepam | >100,000 | -- |
| EDDP 300<br>(2-ethylidene-1,5-dimethyl-3,3-<br>diphenylpyrrolidine, Cutoff = 300 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | >100,000 | -- |
| EMDP | >100,000 | -- |
| Doxylamine | >100,000 | -- |
| Disopyramide | >100,000 | -- |
| LAAM (Levo-alpha-acetylmethadol) HCl | >100,000 | -- |
| Alpha Methadol | >100,000 | -- |
| MTD 300<br>(Methadone, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Doxylamine | >100,000 | -- |
| EDDP | >100,000 | -- |
| EMDP | >100,000 | -- |
| LAAM | >100,000 | -- |
| Alpha Methadol | >100,000 | -- |
| MOP 300<br>(Morphine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| 6-acetylmorphine | 400 | 75% |
| Codeine | 300 | 100% |
| Dihydrocodeine | 1,000 | 30% |
| EthylMorphine | 100 | 300% |
| Heroin | 600 | 50% |
| 6-Monoacetylmorphine | 150 | 200% |
| Hydrocodone | 10,000 | 3% |
| Hydromorphone | 500 | 60% |
| Levorphanol tartrate | 10,000 | 3% |
| Nalorphine HCl | 50,000 | 0.6% |
{20}------------------------------------------------
| Thebaine | 6,240 | 4.8% |
|----------------------------|----------|------|
| s-Monoacetylmorphine | 300 | 100% |
| Morphine-3-β-d-glucuronide | 1,000 | 30% |
| Normorphine | >100,000 | -- |
| Oxycodone | >100000 | -- |
| Oxymorphone | >100000 | -- |
| Norcodeine | >100000 | -- |
| Procaine | >100000 | -- |
| PPX 300<br>(Propoxyphene, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|--------------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Norpropoxyphene | 300 | 100% |
| MDMA 500<br>(3,4-Methylenedioxymethamphetamine HCl,<br>Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine<br>(MDEA) | 300 | 166.7% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 3,000 | 16.7% |
| L-Methamphetamine | 50,000 | 1% |
| D-Methamphetamine | >100,000 | -- |
| D-Amphetamine | >100,000 | -- |
| L-Amphetamine | >100,000 | -- |
| AMP 500<br>(Amphetamine, Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Hydroxyamphetamine | 4,000 | 12.5% |
| (+/-)-Methylenedioxyamphetamine(MDA) | 200 | 250% |
| D,L-Amphetamine | 500 | 100% |
| Diethylstilbestrol | 2,500 | 20% |
| L-Amphetamine | 25,000 | 2% |
| p-Hydroxyamphetamine | 50,000 | 1% |
| Phentermine | 4,000 | 12.5% |
| β-Phenylethylamine | 50,000 | 1% |
| Tyramine | 50,000 | 1% |
| p-Hydroxynorephedrine | 50,000 | 1% |
| D,L-Norephedrine | 50,000 | 1% |
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine<br>(MDEA) | 100,000 | 0.5% |
{21}------------------------------------------------
| D-Methamphetamine | >100,000 | -- |
|--------------------------------------------------|----------|----|
| L-Methamphetamine | >100,000 | -- |
| (+/-)3,4-Methylenedioxymethamphetamine<br>(MDMA) | >100,000 | -- |
| Ephedrine HCl | >100,000 | -- |
| Phenylpropanolamine | >100,000 | -- |
| Benzphetamine | >100,000 | -- |
| L-Ephedrine | >100,000 | -- |
| L-Epinephrine | >100,000 | -- |
| D,L-Epinephrine | >100,000 | -- |
| MET 500<br>(D(+)-Methamphetamine, Cutoff=500ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine<br>(MDEA) | 10,000 | 5% |
| (±)-MDMA | 1,250 | 40% |
| L-Methamphetamine | 12,500 | 4% |
| Fenfluramine | 25,000 | 2% |
| p-Hydroxymethamphetamine | 5,000 | 10% |
| D,L-Methamphetamine | 500 | 100% |
| β-Phenylethylamine | 25,000 | 2% |
| Mephetermine | 25,000 | 2% |
| L-Amphetamine | 40,000 | 1.25% |
| Ephedrine HCl | 100,000 | 0.5% |
| (1R,2S)-(-)-Ephedrine | 100,000 | 0.5% |
| D-Amphetamine | >100,000 | -- |
| Chloroquine | >100,000 | -- |
| (+/-)3,4- Methylenedioxyamphetamine(MDA) | >100,000 | -- |
| L-Phenylephrine | >100,000 | -- |
| TCA 1000<br>(Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Amitriptyline | 1,…
