Accurate Multi Panel Drug Urine Test Cup
Device Facts
| Record ID | K191841 |
|---|---|
| Device Name | Accurate Multi Panel Drug Urine Test Cup |
| Applicant | Healstone Biotech, Inc. |
| Product Code | NFT · Clinical Toxicology |
| Decision Date | Aug 7, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of: [Table of cutoffs]. Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only. The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
Device Story
Device is a lateral flow immunochromatographic test cup for qualitative detection of drugs of abuse in human urine. User adds urine sample to cup; sample migrates via capillary action. Competitive binding principle: if drug concentration is below cutoff, drug-conjugate binds to antibody-coated particles, forming a visible test line; if above cutoff, drug saturates binding sites, preventing test line formation. Control line confirms proper test performance. Used in clinical or home settings by professionals or lay users. Results are visual; healthcare providers use preliminary results to guide clinical decision-making, requiring confirmatory testing (GC/MS or LC/MS) for definitive diagnosis. Benefits include rapid, point-of-care screening for drug presence.
Clinical Evidence
No clinical studies performed. Evidence consists of analytical performance testing (precision, interference, specificity, method comparison against GC/MS or LC/MS) and a lay-user study. Lay-user study included 314 participants (184 male/126 female for Config 1; 178 male/132 female for Config 2) with diverse backgrounds, demonstrating high agreement with professional results across various drug concentrations.
Technological Characteristics
Lateral flow immunochromatographic assay. Materials: test cup, test strips, desiccant. Principle: competitive binding antigen-antibody reaction. Form factor: multi-panel test cup. Connectivity: none (standalone). Sterilization: not specified. Software: none.
Indications for Use
Indicated for qualitative, simultaneous detection of 15 specific drugs of abuse (Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, EDDP, Methamphetamine, MDMA, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) in human urine. Intended for both professional and over-the-counter (OTC) use. Provides preliminary results; requires GC/MS or LC/MS confirmation.
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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- K244043 — AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup · Hangzhou AllTest Biotech Co., Ltd. · Feb 27, 2025
- K230238 — BIOEASY U-Catch MAX Multi-Drug Test Cup, BIOEASY U-Catch MAX Multi-Drug Test Cup Rx · Shenzhen Bioeasy Biotechnology Co., Ltd. · Mar 31, 2023
- K041221 — ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY · Accu-Stat Diagnostics, Inc. · Jul 13, 2004
Submission Summary (Full Text)
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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.
August 7, 2019
Healstone Biotech Inc % Joe Shia, Director LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877
Re: K191841
Trade/Device Name: Accurate Multi Panel Drug Urine Test Cup 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, NGM, NFW Dated: July 5, 2019 Received: July 9, 2019
Dear Joe Shia:
We have reviewed vour 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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
510(k) Number (if known)
Device Name
Accurate Multi Panel Drug Urine Test Cup
#### Indications for Use (Describe)
Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off |
|----------------------------------------------------------|---------|
| Amphetamine (AMP) | 1000 ng |
| Buprenorphine (BUP) | 10 ng |
| Secobarbital (BAR) | 300 ng |
| Oxazepam (BZO) | 300 ng |
| Cocaine (COC) | 300 ng |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng |
| Methamphetamine (MET) | 1000 ng |
| Methylenedioxymethamphetamine (MDMA) | 500 ng |
| Morphine (MOP 300/OPI 2000) | 300 ng |
| Methadone (MTD) | 300 ng |
| Oxycodone (OXY) | 100 ng |
| Phencyclidine (PCP) | 25 ng |
| Propoxyphene (PPX) | 300 ng |
| Nortriptyline (TCA) | 1000 ng |
| Marijuana (THC 50) | 50 ng |
l flow immunochromatographic
barbital, Oxazepam, Cocaine, 2-
nedioxymethamphetamine, Morp
ijuana in human urine at the cuto
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL
Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.
The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
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)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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## 510(k) SUMMARY K191841
- 1 Date August 7, 2019 Submitter Healstone Biotech Inc. 2 650-655 W Kent N. Vancouver, BC V6P6T7 Canada 3 Contact Joe Shia Person LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: Fax: 301-916-6213 Email: shiajl@yahoo.com
- 4 Device Name Accurate® Multi Panel Drug Urine Test Cup
- Classification Class II 5
| Class II | | | |
|--------------|---------------------------------------------------------------------|---------------------------------------|------------|
| Product Code | Target Drug | Regulation Section | Panel |
| NFT | Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| NGL | Buprenorphine (BUP) | 862.3650, Opiate Test System | Toxicology |
| PTH | Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NFV | Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| NFY | Cocaine (COC) | 862.3250, Cocaine Test System | Toxicology |
| PTG | 2-ethylidene-1,5-<br>dimethyl-3,3-<br>diphenylpyrrolidine<br>(EDDP) | 862.3620, Methadone Test System | Toxicology |
| NGG | Methamphetamine (MET) | 862.3610, Methamphetamine Test System | Toxicology |
| NGG | Methylenedioxymethamphetamine (MDMA) | 862.3610, Methamphetamine Test System | Toxicology |
| NGL | | 862.3650, Opiate Test System | Toxicology |
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| Morphine (MOP/OPI) | | |
|----------------------------|--------------------------------------------------------|------------|
| PTG<br>Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
| NGL<br>Oxycodone (OXY) | 862.3650, Opiate Test System | Toxicology |
| NGM<br>Phencyclidine (PCP) | Unclassified, Enzyme<br>Immunoassay Phencyclidine | Toxicology |
| QBF<br>Propoxyphene (PPX) | 862.3700 Propoxyphene test<br>system. | Toxicology |
| QAW<br>Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant<br>drugs test system | Toxicology |
| NFW<br>Marijuana (THC 50) | 862.3870, Cannabinoids Test<br>System | Toxicology |
| K182701 | | |
#### б Predicate Device
Wondfo T-Cup® Multi-Drug Urine Test Cup
#### 7. Intended Use
Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|----------------------------------------------------------|-------------------------|
| Amphetamine (AMP) | 1000 ng/mL |
| Buprenorphine (BUP) | 10ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 300 ng/mL or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1,000 ng/mL |
| Marijuana (THC 50) | 50 ng/mL |
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Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.
The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.
#### Device Description 8.
Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.
| Item | Proposed Device | Predicate (K182701) |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Indication(s) for use | For the qualitative determination of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. | Same |
| Methodology | Competitive binding, lateral flow immunochromatographic assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug and Cut Off Values | Target Drug | Cutoff (ng/mL) |
| | Amphetamine (AMP) | 1000 |
| | Buprenorphine (BUP) | 10 |
| | Secobarbital (BAR) | 300 |
| | Oxazepam (BZO) | 300 |
| | Cocaine (COC) | 300 |
| | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 |
| | Methamphetamine (MET) | 1000 |
#### Substantial Equivalence Information 9.
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| 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 |
| Marijuana (THC 50) | 50 |
| Configurations | Same |
| Intended Use | Same |
#### 10. Test Principle
Accurate® Multi Panel Drug Urine Test Cup is a rapid test for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana 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.
#### 11. Performance Characteristics
- Analytical Performance 1.
- a. Precision
Precision 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. For each concentration, tests were performed two runs per day for 25 days. The results obtained are summarized in the following table.
Accurate® Multi Panel Drug Urine Test Cup BUP
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | 19.1 | 16.1 | 15.2 | 12.9 | 9.4 | 7.1 | 5.4 | 2.4 | 0 |
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| Lot Number | | | | | | | | | |
|------------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
## Accurate® Multi Panel Drug Urine Test Cup PCP
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 50.3 | 43.1 | 36.2 | 30.4 | 25.0 | 17.9 | 12.2 | 6.4 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 26-/24+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Accurate® Multi Panel Drug Urine Test Cup THC
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 100.8 | 88.6 | 72.9 | 65.8 | 50.2 | 39.5 | 25.2 | 12.6 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 28-/22+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 3-/47+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Accurate® Multi Panel Drug Urine Test Cup OXY
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| Lot Number | 200.3 | 170.6 | 150.1 | 118.5 | 98.4 | 77.9 | 52.5 | 28.3 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
Accurate® Multi Panel Drug Urine Test Cup BAR
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|--------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 645.0 | 510.9 | 437.8 | 394.7 | 270.1 | 235.5 | 161.8 | 77.9 | 0 |
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| Lot Number | | | | | | | | | |
|------------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 19-/31+ | 47-/3+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
## Accurate® Multi Panel Drug Urine Test Cup BZO
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 580.3 | 530.3 | 488.3 | 386.6 | 307.9 | 247.0 | 142.3 | 71.8 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 21-/29+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Accurate® Multi Panel Drug Urine Test Cup EDDP
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|--------------------------------|-----------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|----------------|--------------|
| LC/MS<br>(ng/mL)<br>Lot Number | cutoff<br>571.3 | cutoff<br>498.7 | cutoff<br>430.7 | cutoff<br>358.5 | 300.7 | cutoff<br>222.8 | cutoff<br>142.4 | cutoff<br>79.5 | cut-off<br>0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Accurate® Multi Panel Drug Urine Test Cup MTD
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 588.6 | 514.8 | 471.0 | 393.1 | 314.6 | 223.5 | 140.9 | 74.6 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Accurate® Multi Panel Drug Urine Test Cup MOP
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|--------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 591.7 | 504.6 | 470.3 | 384.0 | 289.0 | 244.9 | 163.6 | 74.0 | 0 |
{10}------------------------------------------------
| Lot Number | | | | | | | | | |
|------------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
## Accurate® Multi Panel Drug Urine Test Cup PPX
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL) | 626.7 | 534.8 | 433.6 | 364.2 | 308.6 | 225.3 | 159.1 | 79.4 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 22-/28+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Accurate® Multi Panel Drug Urine Test Cup MDMA
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|-----------------------|--------|--------|--------|--------|---------|--------|--------|--------|---------|
| LC/MS | cutoff | cutoff | cutoff | cutoff | | cutoff | cutoff | cutoff | cut-off |
| (ng/mL)<br>Lot Number | 1208.1 | 863.1 | 711.1 | 592.8 | 516.6 | 375.2 | 259.9 | 124.1 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 19-/31+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
Accurate® Multi Panel Drug Urine Test Cup TCA
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 2024.2 | 1727.6 | 1459.5 | 1276.1 | 1091.2 | 718.8 | 505.0 | 257.5 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 21-/29+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
## Accurate® Multi Panel Drug Urine Test Cup OPI
| Concentration by<br>LC/MS | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|---------------------------|-----------------|----------------|----------------|----------------|--------|----------------|----------------|----------------|------------------|
| | | | | | cutoff | | | | |
{11}------------------------------------------------
| (ng/mL) | 4166.3 | 3535.6 | 3077.2 | 2407.8 | 2008.3 | 1611.8 | 1041.0 | 509.5 | 0 |
|------------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 25-/25+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 23-/27+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
## Accurate® Multi Panel Drug Urine Test Cup COC
| Concentration by<br>LC/MS<br>(ng/mL) | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| | 619.3 | 533.4 | 432.2 | 360.6 | 303.1 | 226.4 | 157.7 | 73 | 0 |
| Lot Number | | | | | | | | | |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 22-/28+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 24-/26+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
#### Accurate® Multi Panel Drug Urine Test Cup AMP
| Concentration by | +100% | +75% | +50% | +25% | Cutoff | -25% | -50% | -75% | -100% |
|--------------------------------|------------------|------------------|------------------|------------------|---------|-----------------|-----------------|-----------------|--------------|
| LC/MS<br>(ng/mL)<br>Lot Number | cutoff<br>2015.9 | cutoff<br>1749.1 | cutoff<br>1496.0 | cutoff<br>1202.3 | 1091.8 | cutoff<br>789.2 | cutoff<br>532.7 | cutoff<br>270.3 | cut-off<br>0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 23-/27+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 2-/48+ | 24-/26+ | 48-/2+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 25-/25+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
Accurate® Multi Panel Drug Urine Test Cup MET
| Concentration by | +100%<br>cutoff | +75%<br>cutoff | +50%<br>cutoff | +25%<br>cutoff | Cutoff | -25%<br>cutoff | -50%<br>cutoff | -75%<br>cutoff | -100%<br>cut-off |
|--------------------------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| LC/MS<br>(ng/mL)<br>Lot Number | 1906.8 | 1629.3 | 1459.1 | 1229.8 | 949.7 | 733.1 | 491.1 | 236.2 | 0 |
| Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 20-/30+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 1-/49+ | 19-/31+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 19-/31+ | 49-/1+ | 50-/0+ | 50-/0+ | 50-/0+ |
The following cutoff values are verified:
{12}------------------------------------------------
| Amphetamine (AMP) | 1000 ng/mL |
|----------------------------------------------------------|-------------------------|
| Buprenorphine (BUP) | 10 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP 300/OPI 2000) | 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 |
| Marijuana (THC 50) | 50 ng/mL |
#### b. Linearity
Not applicable
- c. Stability
The devices are stable at 4-30℃ 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.
| (±)-4-Methylephedrine | Ecgonine methylester | Oxalic acid |
|-----------------------|----------------------|-----------------|
| Acetaminophen | ß-Estradiol | Oxolinic acid |
| Acetophenetidin | Erythromycin | Oxymetazoline |
| N-Acetylprocainamide | Fenoprofen | Papaverine |
| Acetylsalicylic acid | Furosemide | Penicillin G |
| Albumin (100 mg/dL) | Gentisic acid | Perphenazine |
| Aminopyrine | Hemoglobin | Phenelzine |
| Amoxicillin | Hydralazine | Prednisone |
| Ampicillin | Hydrochlorothiazide | (±)-Propranolol |
| Apomorphine | Hydrocortisone | Pseudoephedrine |
{13}------------------------------------------------
| Ascorbic acid | O-Hydroxyhippuric acid | Quinine |
|---------------------|------------------------|--------------------------------------------|
| Aspartame | 3-Hydroxytyramine | Ranitidine |
| Atropine | Ibuprofen | Salicylic acid |
| Benzilic acid | Isoproterenol | Serotonin (5-<br>Hydroxytyramine) |
| Benzoic acid | Isoxsuprine | Sulfamethazine |
| Bilirubin | Ketamine | Sulindac |
| Chloral hydrate | Ketoprofen | Tetrahydrocortisone 3-<br>(β-Dglucuronide) |
| Chloramphenicol | Labetalol | Tetrahydrocortisone 3-<br>acetate |
| Chlorothiazide | Loperamide | Tetrahydrozoline |
| Chlorpromazine | Meperidine | Thiamine |
| Cholesterol | Meprobamate | Thioridazine |
| Clonidine | Methoxyphenamine | Triamterene |
| Cortisone | Nalidixic acid | Trifluoperazine |
| (-)-Cotinine | Naproxen | Trimethoprim |
| Creatinine | Niacinamide | DL-Tryptophan |
| Deoxycorticosterone | Nifedipine | DL-Tyrosine |
| Dextromethorphan | Norethindrone | Uric acid |
| Diclofenac | Noscapine | Verapamil |
| Diflunisal | (±)-Octopamine | Zomepirac |
| Digoxin | | |
- 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.
Compounds that produced positive results are listed below.
| BUP (Buprenorphine,<br>Cutoff=10 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Buprenorphine | 10 | 100% |
| Buprenorphine -3-D-Glucuronide | 160 | 6% |
| Norbuprenorphine | 10 | 100% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | 100000 (negative) | Not detected |
| Oxymorphone | 100000 (negative) | Not detected |
| Hydromorphone | 100000 (negative) | Not detected |
{14}------------------------------------------------
| PCP (Phencyclidine)<br>(Phencyclidine,<br>Cutoff=25 ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Phencyclidine | 25 | 100% |
| 4-Hydroxy Phencyclidine | 12500 | 0.2% |
| THC<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 -9-COOH | 30 | 167% |
| (-)-11-nor-9-carboxy-Δ 9-THC | 50 | 100% |
| (±)-11-nor-9-Carboxy-Δ9-THC | 50 | 100% |
| 11-nor-Δ9-THC -carboxy glucuronide | 100 | 50% |
| 11-hydroxy-Δ9-Tetrahydrocannabinol | 5,000 | 1% |
| Δ8- Tetrahydrocannabinol | 1,300 | 4% |
| Δ9- Tetrahydrocannabinol | 5,000 | 1% |
| Cannabinol | 20,000 | 0.25% |
| Cannabidiol | 100000(negative) | Not Detected |
| OXY<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 | 0.1% |
| Hydrocodone | 5,000 | 2% |
| Hydromorphone | 25,000 | 0.4% |
| Levorphanol | 10,000 | 1 % |
| Oxycodone | 100 | 100% |
| Oxymorphone | 200 | 50% |
| Dihydrocodeine | 100000(negative) | Not Detected |
| Codeine | 100000(negative) | Not Detected |
| Morphine | 100000(negative) | Not Detected |
| Acetylmorphine | 100000(negative) | Not Detected |
| Buprenorphine | 100000(negative) | Not Detected |
| Ethylmorphine | 100000(negative) | Not Detected |
| Thebaine | 100000(negative) | Not Detected |
| BAR<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% |
{15}------------------------------------------------
| Aprobarbital | 250 | 120% |
|--------------------|-------|------|
| Butabarbital | 2,500 | 12% |
| Butethal | 100 | 300% |
| Butalbital | 2,500 | 12% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 250 | 120% |
| Phenobarbital | 250 | 120% |
| Secobarbital | 300 | 100% |
| BZO<br>(Oxazepam, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------|--------------------------------------------------------------------------|------------------------|
| Alprazolam | 200 | 150% |
| a-Hydroxyalprazolam | 1,260 | 24% |
| Bromazepam | 1,560 | 19% |
| Chlordiazepoxide | 1,560 | 19% |
| Clobazam | 100 | 300% |
| Clonazepam | 2,500 | 12% |
| Clorazepate dipotassium | 200 | 150% |
| Desalkylflurazepam | 400 | 75% |
| Diazepam | 200 | 150% |
| Estazolam | 2,500 | 12% |
| Flunitrazepam | 400 | 75% |
| Midazolam | 12,500 | 2.4% |
| Nitrazepam | 100 | 300% |
| Norchlordiazepoxide | 200 | 150% |
| Nordiazepam | 400 | 75% |
| Temazepam | 100 | 300% |
| Triazolam | 2,500 | 12% |
| Demoxepam | 2,000 | 15% |
| Flurazepam | 500 | 60% |
| D,L-Lorazepam | 1,560 | 20% |
| Oxazepam | 300 | 100% |
| RS-Lorazepam glucuronide | 160 | 188% |
| Delorazepam | 100000 (negative) | Not detected |
| EDDP<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 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| 2-ethylidene-1,5-dimethyl-3,3- diphenylpyrrolidine | 300 | 100% |
| Methadone | >100000 | Not detected |
| EMDP | >100000 | Not detected |
{16}------------------------------------------------
| Doxylamine | >100000 | Not detected |
|----------------------------------|---------|--------------|
| Disopyramide | >100000 | Not detected |
| LAAM (Levo-alpha-acetylmethadol) | >100000 | Not detected |
| Alpha Methadol | >100000 | Not detected |
| MTD<br>(Methadone, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------|--------------------------------------------------------------------------|------------------------|
| Methadone | 300 | 100% |
| Doxylamine | >100000 | Not detected |
| EDDP | >100000 | Not detected |
| EMDP | >100000 | Not detected |
| LAAM | >100000 | Not detected |
| Alpha Methadol | >100000 | Not detected |
| MOP 300<br>(Morphine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| Morphine | 300 | 100% |
| Normorphine | 300 | 100% |
| s-Monoacetylmorphine | 300 | 100% |
| Codeine | 300 | 100% |
| Ethyl Morphine | 100 | 300% |
| Heroin | 600 | 50% |
| Hydrocodone | 10000 | 3% |
| Hydromorphone | 500 | 60% |
| Morphinie-3-β-d-glucuronide | 1000 | 30% |
| Thebaine | 6,240 | 4.8% |
| Levorphanol | 10000 | 3% |
| 6-Monoacetylmorphine (6-MAM) | 150 | 200% |
| 6-acetylmorphine | 400 | 75% |
| Dihydrocodeine | 1000 | 30% |
| Normorphine | >100000 | Not detected |
| Oxycodone | >100000 | Not detected |
| Oxymorphone | >100000 | Not detected |
| Norcodeine | >100000 | Not detected |
| Procaine | >100000 | Not detected |
| PPX<br>(Propoxyphene, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|----------------------------------------|--------------------------------------------------------------------------|------------------------|
| d-Propoxyphene | 300 | 100% |
{17}------------------------------------------------
| d-Norpropoxyphene | 300 | 100% |
|-------------------|-----|------|
|-------------------|-----|------|
| MDMA<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-Methylenedioxymethamphetamine (MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine HCl (MDA) | 3000 | 17% |
| 3,4-Methylenedioxyethylamphetamine (MDEA) | 300 | 167% |
| l-Methamphetamine | 50000 | 1% |
| d-methamphetamine | 100000(Negative) | Not detected |
| d-amphetamine | 100000(Negative) | Not detected |
| l-amphetamine | 100000(Negative) | Not detected |
| TCA 1000 (Nortriptyline, Cutoff=1000ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|--------------------------------------------|--------------------------------------------------------------------|--------------------|
| Chlorpheniramine maleate | 50000 | 2% |
| Nortriptyline | 1000 | 100% |
| Nordoxepine | 1000 | 100% |
| Trimipramine | 10000 | 10% |
| Amitriptyline | 1500 | 66.7% |
| Promazine | 50000 | 2% |
| Desipramine | 1000 | 100% |
| Imipramine | 1000 | 100% |
| Clomipramine | 10000 | 10% |
| Doxepin | 2000 | 50% |
| Maprotiline | 100000(Negative) | Not detected |
| Promethazine | 100000(Negative) | Not detected |
| Cyclobenzaprine | 5000 | 20% |
| Norclomipramine | 12500 | 8% |
| Duloxetine | 10000 | 10% |
| COC<br>(Benzoylecgonine, Cutoff=300ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------------|--------------------------------------------------------------------------|------------------------|
| Benzoylecgonine | 300 | 100% |
| Cocaine | 300 | 100% |
| Cocaethylene | 300 | 100% |
| Ecgonine | 300 | 100% |
| Ecgonine methyl ester | 100000 (negative) | Not detected |
| Norcocaine | 100000 (negative) | Not detected |
{18}------------------------------------------------
| AMP<br>(d-Amphetamine, Cutoff=1000ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)-4-Hydroxyamphetamine | 8000 | 12.5% |
| Methylenedioxyamphetamine(MDA) | 400 | 250% |
| D,L-Amphetamine | 1,000 | 100% |
| D-Amphetamine | 1,000 | 100% |
| Diethylstilbestrol | 5,000 | 20% |
| L-Amphetamine | 50,000 | 2% |
| Phentermine | 8,000 | 12.5% |
| ß-Phenylethylamine | 100000 | 1% |
| p-Hydroxynorephedrine | 100000 | 1% |
| p-Hydroxyamphetamine | 100,000 | 1% |
| d/l-Norephedrine | 100,000 | 1% |
| d-Methamphetamine | 50,000 | 2% |
| l-Methamphetamine | 1,000 | 100% |
| Ephedrine | 100000 (negative) | Not detected |
| Methylenedioxymethamphetamine<br>(MDMA) | 100000 (negative) | Not detected |
| Phenylpropanolamine | 100000 (negative) | Not detected |
| Benzphetamine | 100000 (negative) | Not detected |
| l-Ephedrine | 100000 (negative) | Not detected |
| l-Epinephrine | 100000 (negative) | Not detected |
| d/l-Epinephrine | 100000 (negative) | Not detected |
| MET<br>(D(+)-Methamphetamine, Cutoff=1000ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|------------------------------------------------------|--------------------------------------------------------------------------|------------------------|
| (+/-)3,4-Methylenedioxy-n-ethylamphetamine<br>(MDEA) | 20,000 | 5% |
| (±)-MDMA | 2,500 | 40% |
| d-Methamphetamine | 1,000 | 100% |
| l-Methamphetamine | 25,000 | 4% |
| d/l-Methamphetamine | 1,000 | 100% |
| p-Hydroxymethamphetamine | 10,000 | 10% |
| L-Amphetamine | 75000 | 1.3% |
| β-Phenylethylamine | 50000 | 2% |
| Mephetermine | 50000 | 2% |
| Fenfluramine | 50000 | 2% |
| D-Amphetamine | 100000(negative) | Not Detected |
| Chloroquine | 100000(negative) | Not Detected |
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| (+/-)3,4-Methylenedioxyamphetamine (MDA) | 100000(negative) | Not Detected |
|------------------------------------------|------------------|--------------|
| Trimethobenzamide | 100000(negative) | Not Detected |
| d,l-Amphetamine | 100000(negative) | Not Detected |
| (1R,2S)-(-)-Ephedrine | 100000(negative) | Not Detected |
| l-phenylephrine | 100000(negative) | Not Detected |
| OPI<br>(Morphine, Cutoff=2000ng/mL) | Minimum concentration<br>required to obtain a<br>positive result (ng/mL) | % Cross-<br>Reactivity |
|-------------------------------------|--------------------------------------------------------------------------|------------------------|
| Morphine | 2000 | 100% |
| Codeine | 1000 | 200% |
| Ethyl Morphine | 2500 | 80% |
| Hydrocodone | 5000 | 40% |
| Hydromorphone | 25000 | 8% |
| Levorphanol | 10000 | 20% |
| 6-Monoacetylmorphine (6-MAM) | 1500 | 133% |
| Morphine 3-β-D-glucuronide | 2000 | 100% |
| Norcodeine | 4000 | 50% |
| Normorphine | 5000 | 40% |
| Oxymorphone | 75000 | 3% |
| Thebaine | 13000 | 15% |
| Heroin | 5000 | 40% |
| s-Monoacetylmorphine | 2000 | 100% |
| Dihydrocodeine | 1500 | 133% |
| Nalorphine | 5000 | 40% |
| 6-acetylmorphine | 2,500 | 80% |
| Procaine | 100000(negative) | Not Detected |
| Oxycodone | 100000(negative) | Not Detected |
#### f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity, urine samples with specific gravity from 1.000 to 1.035 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine specific gravity between 1.000 and 1.035 has no effect on the accuracy and precision of the test device.
To investigate the effect of urine pH, urine samples with pH value from 4 to 9 were spiked with target drugs at +50% cutoff and -50% cutoff levels. Three operators tested samples using test devices from three different lots. The results were all positive for samples at +50% cutoff and all negative for samples at -50% cutoff, indicating that urine pH value between 4.0 and 9.0 has no effect on the accuracy and precision of the test device.
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- 2. Comparison Studies
The method comparison studies for Accurate® Multi Panel Drug Urine Test cup were performed inhouse with three operators.
Operators ran 80 (40 negative and 40 positive) unaltered urine samples were blind labeled and compared to LC/MS or GC/MS results. The results are presented in the table below:
BUP
| Accurate<br>® | | Drug-Free | Low<br>Negative by<br>LC/MS (less<br>than -50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between -50%<br>and the Cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|---------------|----------|-----------|-------------------------------------------------|-------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer A | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
| Viewer B | Positive | 0 | 0 | 3 | 14 | 23 |
| | Negative | 10 | 16 | 11 | 3 | 0 |
| Viewer C | Positive | 0 | 0 | 1 | 14 | 23 |
| | Negative | 10 | 16 | 13 | 3 | 0 |
#### Discordant Results for BUP:
| Viewer | Sample Number | LC/MS Result (ng/mL) | Accurate Result |
|----------|---------------|----------------------|-----------------|
| Viewer A | MCP-BUP-A75 | 10.2 | - |
| Viewer A | MCP-BUP-A42 | 10.9 | - |
| Viewer A | MCP-BUP-A61 | 11.2 | - |
| Viewer B | MCP-BUP-A58 | 1…
