Who is the manufacturer of BIOEASY Multi-Drug Test Cup?

Shenzhen Bioeasy Biotechnology Co., Ltd. filed the 510(k) submission for BIOEASY Multi-Drug Test Cup (K182530).

What is the FDA product code for BIOEASY Multi-Drug Test Cup?

NFT. It is classified under 21 CFR 862.3100 as a Class 2 device in the Clinical Toxicology panel.

What is the regulatory pathway for BIOEASY Multi-Drug Test Cup?

510(k) clearance (submission type: Traditional).

What are the predicate devices for BIOEASY Multi-Drug Test Cup?

Rapid Single/Multi-drug Test Cup (k153050).

Who can help prepare an FDA 510(k) submission like BIOEASY Multi-Drug Test Cup?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BIOEASY Multi-Drug Test Cup

K182530 · Shenzhen Bioeasy Biotechnology Co., Ltd. · NFT · Nov 9, 2018 · Clinical Toxicology

Device Facts

Record ID	K182530
Device Name	BIOEASY Multi-Drug Test Cup
Applicant	Shenzhen Bioeasy Biotechnology Co., Ltd.
Product Code	NFT · Clinical Toxicology
Decision Date	Nov 9, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.3100
Device Class	Class 2

Intended Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: Drug(Identifier) Cut-off level Amphetamine 1000 ng/mL Oxazepam 300 ng/mL Cocaine 300 ng/mL Marijuana 50 ng/mL Methamphetamine 1000 ng/mL Morphine 300 ng/mL Oxycodone 100 ng/mL Secobarbital 300 ng/mL Buprenorphine 10 ng/mL Methylenedioxy-methamphetamine 500 ng/mL Phencyclidine 25 ng/mL Methadone 300 ng/mL Nortriptyline 1000 ng/mL d-Propoxyphene 300 ng/mL Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

Device Story

Single-use lateral flow immunochromatographic assay cup for qualitative detection of drugs of abuse in human urine; utilizes competitive binding principle with monoclonal antibodies. Urine sample migrates via capillary action; target drugs below cutoff saturate binding sites, allowing antibody-coated particles to bind immobilized drug-conjugate, forming visible test line. Target drugs above cutoff saturate antibody sites, preventing test line formation. Control line confirms proper test performance. Used in point-of-care or home settings by lay users or professionals. Provides preliminary results; requires GC/MS or LC/MS confirmation. Aids in identifying potential drug presence for clinical consideration.

Clinical Evidence

No clinical studies performed. Analytical performance validated via precision/reproducibility studies (25 days, 2 runs/day) and method comparison studies against LC/MS using 80 clinical samples per analyte. Lay user study conducted with 300 participants across diverse demographics, demonstrating high accuracy (90-100%) across various drug concentrations relative to cutoffs. Flesch-Kincaid reading grade level of 7 achieved for package insert.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Single-use urine cup form factor. Materials: monoclonal mouse antibodies, drug-conjugates. Stability: 24 months at 4-30°C. No electronic components or software algorithms.

Indications for Use

Indicated for qualitative, simultaneous detection of 14 drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, MDMA, Phencyclidine, Methadone, Nortriptyline, d-Propoxyphene) in human urine. Intended for over-the-counter 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).

Predicate Devices

Rapid Single/Multi-drug Test Cup (k153050)

Related Devices

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
K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · Nov 19, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ Build Correspondence Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 9, 2018 Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia, Director LSI International 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Re: k182530 Trade/Device Name: BIOEASY Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, NGM, PTG, QAW, QBF Dated: September 9, 2018 Received: September 14, 2018 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Kellie B. Kelm -S for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) k182530 Device Name BIOEASY Multi-Drug Test Cup #### Indications for Use (Describe) BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: | Drug(Identifier) | Cut-off level | |--------------------------------|---------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 300 ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ ## K182530 510(k) SUMMARY - November 9, 2018 1. Date: - Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1, Liuxian 1st Road Baoan District Shenzhen, China 518101 - Joe Shia 3. Contact person: LSI International Inc. 504 East Diamond Ave. Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com - 4. Device Name: BIOEASY Multi-Drug Test Cup | Classification: | Class 2 | | | |-------------------------------------------|----------------|-------------------------------------------------------------------|-----------------| | Product Code | Classification | Regulation Section | Panel | | NFT Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) | | NFW Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) | | NFY Cocaine | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) | | NGG Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGI Morphine | II | 21 CFR § 862.3640, Morphine Test System | Toxicology (91) | | NFV Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) | | NGL Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | PTH Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) | | NGL Buprenorphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) | | NGG Methylenedioxy- methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) | | NGM Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) | | PTG Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) | | QAW Nortriptyline | II | 21 CFR, 862.3910 Tricyclic Antidepressant Drugs Test System | Toxicology (91) | | QBF Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) | 5. Predicate Devices: K153050 {5}------------------------------------------------ The CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid Multi-Drug Test Cup - 6. Indications for Use BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of: | Drug (Identifier) | Cut-off level | |--------------------------------|---------------| | Amphetamine | 1000 ng/mL | | Oxazepam | 300 ng/mL | | Cocaine | 300 ng/mL | | Marijuana | 50 ng/mL | | Methamphetamine | 1000 ng/mL | | Morphine | 300 ng/mL | | Oxycodone | 100 ng/mL | | Secobarbital | 300 ng/mL | | Buprenorphine | 10 ng/mL | | Methylenedioxy-methamphetamine | 500 ng/mL | | Phencyclidine | 25 ng/mL | | Methadone | 300 ng/mL | | Nortriptyline | 1000 ng/mL | | d-Propoxyphene | 300 ng/mL | Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes. The test 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 exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. - 7. Device Description The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch - 8. Substantial Equivalence Information A summary comparison of features of the BIOEASY Multi-Drug Test Cup tests and the predicate devices is provided in following table. {6}------------------------------------------------ | Item | Device | Predicate - K153050 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------| | Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same (but the number of drugs detected is different) | | Calibrator and Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml Oxazepam (BZO):300 ng/ml Cocaine(COC): 300 ng/ml Marijuana (THC):50 ng/ml Methamphetamine (MET): 1,000 ng/ml Morphine (MOR): 300ng/ml Oxycodone(OXY) : 100 ng/ml Secobarbital (BAR): 300 ng/ml Buprenorphine (BUP): 10 ng/ml Methylenedioxy- methamphetamine(MDMA): 500 ng/ml Phencyclidine (PCP): 25 ng/ml Methadone (MTD): 300 ng/ml Nortriptyline (TCA): 1000 ng/ml Propoxyphene (PPX): 300 ng/ml | Same | | Methodology | Competitive binding, lateral flow immunochromatographic assays based on the principle of antigen antibody immunochemistry. | Same | | Type of Test | Qualitative | Same | | Specimen Type | Human Urine | Same | | Intended Use | For over-the-counter | Same | | Configurations | Cup | Same | #### Table 1: Features Comparison of BIOEASY Multi-Drug Test Cup tests and the Predicate Devired #### 9. Test Principle The BIOEASY Multi-Drug Test Cup tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propox yphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices {7}------------------------------------------------ regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly. #### 10. Performance Characteristics - 1. Analytical Performance #### a. Precision 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. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following tables. #### Amphetamine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |------------|---------------|--------------|--------------|-------------|---------|--------------|--------------|--------------|---------------| | Lot 1 | 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### Secobarbital | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### Buprenorphine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### Oxazepam | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### Cocaine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | {8}------------------------------------------------ ## Methylenedioxy-methamphetamine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/24+ | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | ## Methamphetamine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 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+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Morphine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Methadone | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Oxycodone | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 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+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | ## Phencyclidine | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 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+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Propoxyphene | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | +25% cut off | +50% cut off | +75% cut off | +100% cut off | | |---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|--------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | # Nortriptyline {9}------------------------------------------------ | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 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- | #### Marijuana | Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off | |---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------| | Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | | Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- | #### c. Stability The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability determinations are ongoing at both 4 °C and 30 °C. #### d. Interference Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL (albumin was tested at 100 mg/dL) are summarized in the following tables. | Acetaminophen | β-Estradiol | Oxalic acid | |----------------------|------------------------|--------------------------------| | Acetophenetidin | Erythromycin | Oxolinic acid | | N-Acetylprocainamide | Ethanol | Oxymetazoline | | Acetylsalicylic acid | Fenoprofen | Papaverine | | Albumin (100 mg/dL) | Furosemide | Penicillin G | | Aminopyrine | Gentisic acid | Perphenazine | | Amoxicillin | Hemoglobin | Phenelzine | | Ampicillin | Hydralazine | Prednisone | | Apomorphine | Hydrochlorothiazide | (±)-Propranolol | | Ascorbic acid | Hydrocortisone | Pseudoephedrine | | Aspartame | O-Hydroxyhippuric acid | Quinine | | Atropine | 3-Hydroxytyramine | Ranitidine | | Benzilic acid | Ibuprofen | Salicylic acid | | Benzoic acid | Isoproterenol | Serotonin (5- Hydroxytyramine) | | Bilirubin | Isoxsuprine | Sulfamethazine | | Chloral hydrate | Ketamine | Sulindac | | Chloramphenicol | Ketoprofen | Tetrahydrocortisone 3-(β- | | | | Dglucuronide) | | Chlorothiazide | Labetalol | Tetrahydrocortisone 3-acetate | | Chlorpromazine | Loperamide | Tetrahydrozoline | | Cholesterol | Meperidine | Thiamine | | Clonidine | Meprobamate | Thioridazine | | Cortisone | Methoxyphenamine | Triamterene | | (-)-Cotinine | Nalidixic acid | Trifluoperazine | | Creatinine | Naloxone | Trimethoprim | | Deoxycorticosterone | Naltrexone | DL-Tryptophan | | Dextromethorphan | Naproxen | Tyramine | | Diclofenac | Niacinamide | DL-Tyrosine | {10}------------------------------------------------ | Diflunisal | Nifedipine | Uric acid | |-----------------------|----------------|-----------| | Digoxin | Norethindrone | Verapamil | | Diphenhydramine | Noscapine | Zomepirac | | Ecgonine methyl ester | (±)-Octopamine | | e. Specificity To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. | AMP(Amphetamine) (D - Amphetamine, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity | |-----------------------------------------------------------|-------------------------|-------------------| | D - Amphetamine | Positive at 1000 ng/mL | 100% | | L - Amphetamine | Positive at 20000 ng/mL | 5% | | DL - Amphetamine | Positive at 3000 ng/mL | 33% | | Phentermine | Positive at 30000 ng/mL | 3.3% | | Hydroxyamphetamine | Positive at 8000 ng/mL | 12.5% | | Methylenedioxyamphetamine (MDA) | Positive at 20000 ng/mL | 5% | | d-Methamphetamine | Positive> 100000 ng/mL | <1% | | 1-Methamphetamine | Positive> 100000 ng/mL | <1% | | Ephedrine | Positive> 100000 ng/mL | <1% | | Methylenedioxyethylamphetamine (MDE) | Positive> 100000 ng/mL | <1% | | 3,4-methylenedioxy-methamphetamine (MDMA) | Positive> 100000 ng/mL | <1% | | BAR(Barbital) (Secobarbital, Cut-off=300 ng/mL) | Result | %Cross-Reactivity | |----------------------------------------------------|------------------------|-------------------| | Secobarbital | Positive at 300 ng/mL | 100% | | Amobarbital | Positive at 1000 ng/mL | 30% | | Alphenal | Positive at 62.5 ng/mL | 480% | | Aprobarbital | Positive at 250 ng/mL | 120% | | Butabarbital | Positive at 100 ng/mL | 300% | | Butethal | Positive at 500 ng/mL | 60% | | Butalbital | Positive at 5000 ng/mL | 6% | | Cyclopentobarbital | Positive at 500 ng/mL | 60% | | Pentobarbital | Positive at 200 ng/mL | 150% | | Phenobarbital | Positive at 300 ng/mL | 100% | | BUP(Buprenorphine) (Buprenorphine, Cut-off=10 ng/mL) | Result | %Cross-Reactivity | |---------------------------------------------------------|------------------------|-------------------| | Buprenorphine | Positive at 10 ng/mL | 100% | | Buprenorphine -3-D-Glucuronide | Positive at 10 ng/mL | 100% | | Norbuprenorphine | Positive at 50 ng/mL | 20% | | Norbuprenorphine-3-D-Glucuronide | Positive at 10 ng/mL | 10% | | Morphine | Positive> 100000 ng/mL | <0.01% | | Oxymorphone | Positive> 100000 ng/mL | <0.01% | | Hydromorphone | Positive> 100000 ng/mL | <0.01% | | BZO(Benzodiazepines) | Result | %Cross-Reactivity | |----------------------|--------|-------------------| |----------------------|--------|-------------------| {11}------------------------------------------------ | (Oxazepam, Cut-off=300 ng/mL) | | | |-------------------------------|-------------------------|--------| | Oxazepam | Positive at_300_ng/mL | 100% | | Alprazolam | Positive at_150_ng/mL | 200% | | a-Hydroxyalprazolam | Positive at_1000_ng/mL | 30% | | Bromazepam | Positive at_1000_ng/mL | 30% | | Chlordiazepoxide | Positive at_63_ng/mL | 476.2% | | Clonazepam | Positive at_2500_ng/mL | 12% | | Clobazam | Positive at_75_ng/mL | 400% | | Clorazepate dipotassium | Positive at_100_ng/mL | 300% | | Desalkylflurazepam | Positive at_500_ng/mL | 60% | | Diazepam | Positive at_500_ng/mL | 60% | | Estazolam | Positive at_500_ng/mL | 60% | | Flunitrazepam | Positive > 50000 ng/mL | <0.6% | | D,L-Lorazepam | Positive at_10000_ng/mL | 3% | | Midazolam | Positive at_10000_ng/mL | 3% | | Nitrazepam | Positive at_75_ng/mL | 400% | | Norchlordiazepoxide | Positive at_62.5_ng/mL | 480% | | Nordiazepam | Positive at_125_ng/mL | 240% | | Temazepam | Positive at_75_ng/mL | 400% | | Triazolam | Positive at_1000_ng/mL | 33% | | COC(Cocaine) (Benzoylecgonine, Cut-off=300 ng/mL) | Result | %Cross-Reactivity | |------------------------------------------------------|--------------------------|-------------------| | Benzoylecgonine | Positive at 300 ng/mL | 100% | | Cocaine HCl | Positive at 750 ng/mL | 40% | | Cocaethylene | Positive at 12500 ng/mL | 2.4% | | Ecgonine | Positive at 32000 ng/mL | 0.9% | | Norcocaine | Positive at 100000 ng/mL | 0.3% | | MDMA(Methylenedioxymethamphetamine) (Methylenedioxymethamphetamine, Cut-off=500 ng/mL) | Result | %Cross-Reactivity | |----------------------------------------------------------------------------------------------|------------------------|-------------------| | Methylenedioxymethamphetamine (MDMA) | Positive at 500 ng/mL | 100% | | 3,4-Methylenedioxyamphetamine (MDA) | Positive at 5000 ng/mL | 10% | | 3,4-Methylenedioxyethylamphetamine (MDEA) | Positive at 300 ng/mL | 166.7% | | d-methamphetamine | Positive > 50000 ng/mL | <1% | | d-amphetamine | Positive > 50000 ng/mL | <1% | | l-amphetamine | Positive > 50000 ng/mL | <1% | | l-methamphetamine | Positive > 50000 ng/mL | <1% | | MET(Methamphetamine) (D(+)-Methamphetamine, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity | |--------------------------------------------------------------------|-------------------------|-------------------| | D(+)-Methamphetamine | Positive at 1000 ng/mL | 100% | | (+/-)3,4-Methylenedioxy-n-ethylamphetamine (MDEA) | Positive at 10000 ng/mL | 10% | | D/L-Methamphetamine | Positive at 1000 ng/mL | 100% | | p-Hydroxymethamphetamine | Positive at 10000 ng/mL | 10% | {12}------------------------------------------------ | D-Amphetamine | Positive > 100000 ng/mL | <1% | |----------------------------------------------|-------------------------|-------| | L-Amphetamine | Positive >100000 ng/mL | <1% | | Chloroquine | Positive at 50000 ng/mL | 2% | | (+/-)-Ephedrine | Positive at 4000 ng/mL | 25% | | L-Methamphetamine | Positive at 10000 ng/mL | 10% | | (+/-)3,4-Methylenedioxyamphetamine (MDA) | Positive >100000 ng/mL | <1% | | β-Phenylethylamine | Positive at 7500 ng/mL | 13.3% | | Trimethobenzamide | Positive at 20000 ng/mL | 5% | | (+/-)3,4-methylenedioxymethamphetamine(MDMA) | Positive at 10000 ng/mL | 10% | | MOP(Morphine) (Morphine, Cut-off=300 ng/mL) | Result | %Cross-Reactivity | |------------------------------------------------|--------------------------|-------------------| | Morphine | Positive at_300 ng/mL | 100% | | Codeine | Positive at 300 ng/mL | 100% | | Ethylmorphine | Positive at_310 ng/mL | 96.8% | | Hydrocodone | Positive at_25000 ng/mL | 1.2% | | Hydromorphone | Positive 10000 ng/mL | 3% | | Levorphanol | Positive > 100000 ng/mL | <0.3% | | 6-Acetylmorphine | Positive at_250 ng/mL | 120% | | Morphine-3- β -D-glucuronide | Positive at 10000 ng/mL | 3% | | Normorphine | Positive at 100000 ng/mL | 0.3% | | Oxycodone | Positive > 10000 ng/mL | <3% | | Oxymorphone | Positive > 10000 ng/mL | <3% | | Procaine | Positive > 10000 ng/mL | 3% | | Thebaine | Positive > 10000 ng/mL | <3% | | Heroin | Positive at 500 ng/mL | 60% | | MTD(Methadone) (Methadone, Cut-off=300 ng/mL) | Result | %Cross-Reactivity | |--------------------------------------------------|------------------------|-------------------| | Methadone | Positive at 300ng/mL | 100% | | Doxylamine | Positive at 5000ng/mL | 6% | | LAAM | Positive at 10000ng/mL | 3% | | Alpha Methadol | Positive at 2000ng/mL | 15% | | EDDP | Positive > 100000ng/mL | <0.3% | | EMDP | Positive > 100000ng/mL | <0.3% | | OXY(Oxycodone) (Oxycodone, Cut-off=300 ng/mL) | Result | %Cross-Reactivity | |--------------------------------------------------|-----------------------|-------------------| | Oxycodone | Positive at 100 ng/mL | 100% | | Dihydrocodeine | Positive >100000ng/mL | <0.1% | | Codeine | Positive >100000ng/mL | <0.1% | | Hydromorphone | Positive >100000ng/mL | <0.1% | | Morphine | Positive >100000ng/mL | <0.1% | | Buprenorphine | Positive >100000ng/mL | <0.1% | | Ethylmorphine | Positive >100000ng/mL | <0.1% | | Oxymorphone | Positive at 250 ng/mL | 40% | {13}------------------------------------------------ | r y y are a | 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - | 0 00/ | |-------------|---------------------------------------------------------|-----------| | Hydrocodone | Positive at 3125 ng/mL | J. L. / V | | PCP(Phencyclidine) (Phencyclidine, Cut-off=25 ng/mL) | Result | %Cross-Reactivity | |---------------------------------------------------------|----------------------|-------------------| | Phencyclidine | Positive at 25 ng/mL | 100% | | 4-Hydroxyphencyclidine | Positive at 75 ng/mL | 33.3% | | PPX(Propoxyphene) (d-Propoxyphene, Cut-off=300ng/mL) | Result | %Cross-Reactivity | |---------------------------------------------------------|----------------------------------------------------------------------|-------------------| | d-Propoxyphene | Positive at 300 ng/mL | 100% | | D-Norpropoxyphene | Positive at 333 ng/mL | 90.1% | | TCA(Nortriptyline) (Nortriptyline, Cut-off=1000 ng/mL) | Result | %Cross-Reactivity | |-----------------------------------------------------------|-------------------------|-------------------| | Nortriptyline | Positive at 1000 ng/mL | 100% | | Amitriptyline | Positive at 750 ng/mL | 133.3% | | Clomipramine | Positive at 10000 ng/mL | 10% | | Desipramine | Positive at 200 ng/mL | 500% | | Doxepin | Positive at 1250ng/mL | 80% | | Imipramine | Positive at 625 ng/mL | 160% | | Maprotiline | Positive at 2000 ng/mL | 50% | | Nordoxepin | Positive at 1000 ng/mL | 100% | | Promazine | Positive at 1500 ng/mL | 66.7% | | Promethazine | Positive at 25000 ng/mL | 4% | | Trimipramine | Positive at 3000 ng/mL | 33.3% | | Cyclobenzaprine | Positive at 5000 ng/mL | 20% | | Norclomipramine | Positive at 3000 ng/mL | 33.3% | | THC(Cannabinoids) (11-nor-△9-THC-9-COOH, Cut-off = 50 ng/mL) | Result | % Cross-Reactivity | |-----------------------------------------------------------------|-------------------------|--------------------| | 11-nor-△9-THC-9-COOH | Positive at _50_ ng/mL | 100% | | 11-Hydroxy-△9-Tetrahydrocannabinol | Positive at _50_ ng/mL | 100% | | 11-Nor-△8-Tetrahydrocannabinol-9-COOH | Positive at _50_ ng/mL | 100% | | Cannabinol | Positive at 20000 ng/mL | 0.25% | | △8-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% | | △9-Tetrahydrocannabinol | Positive at 15000 ng/mL | 0.33% | | Cannabidiol | Positive> 100000 ng/mL | <0.05% | | 11-Nor-△9-THC-carboxy glucuronide | Positive at _75_ ng/mL | 66.7% | | (-)-11-nor-9-carboxy-△ 9-THC | Positive at _50_ ng/mL | 100% | #### f. Effect of Urine Specific Gravity and Urine pH To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices. {14}------------------------------------------------ #### 2. Comparison Studies Method comparison studies for the BIOEASY Multi-Drug Test Cup tests were performed inhouse with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below. #### Amphetamine | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |-------------------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------| | Viewer A Positive | 0 | 0 | 2 | 19 | 19 | | Viewer A Negative | 5 | 16 | 17 | 2 | 0 | | Viewer B Positive | 0 | 0 | 4 | 20 | 19 | | Viewer B Negative | 5 | 16 | 15 | 1 | 0 | | Viewer C Positive | 0 | 0 | 3 | 19 | 19 | | Viewer C Negative | 5 | 16 | 16 | 2 | 0 | | | Discordant Results | | | |----------|--------------------|--------------|-------------------------------| | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | | Viewer A | AMPC439 | 981 | Positive | | Viewer A | AMPC449 | 768 | Positive | | Viewer B | AMPC439 | 981 | Positive | | Viewer B | AMPC449 | 768 | Positive | | Viewer B | AMPC412 | 976 | Positive | | Viewer B | AMPC387 | 981 | Positive | | Viewer C | AMPC412 | 976 | Positive | | Viewer C | AMPC493 | 961 | Positive | | Viewer C | AMPC387 | 981 | Positive | | Viewer A | AMPC341 | 1010 | Negative | | Viewer A | AMPC482 | 1010 | Negative | | Viewer B | AMPC482 | 1010 | Negative | | Viewer C | AMPC341 | 1010 | Negative | | Viewer C | AMPC352 | 1120 | Negative | #### Secobarbital | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer | Positive | 0 | 0 | 2 | 17 | 22 | | A | Negative | 6 | 15 | 17 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 16 | 22 | | B | Negative | 6 | 15 | 17 | 2 | 0 | | Viewer | Positive | 0 | 0 | 1 | 17 | 22 | {15}------------------------------------------------ | C | Negative | 6 | 15 | 18 | 1 | 0 | |--------------------|---------------|--------------|----------------------------|----|---|---| | Discordant Results | | | | | | | | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | | | | | Viewer A | BARC477 | 291 | Positive | | | | | Viewer A | BARC375 | 265 | Positive | | | | | Viewer B | BARC477 | 291 | Positive | | | | | Viewer B | BARC375 | 265 | Positive | | | | | Viewer C | BARC364 | 269 | Positive | | | | | Viewer A | BARC384 | 312 | Negative | | | | | Viewer B | BARC384 | 312 | Negative | | | | | Viewer B | BARC414 | 315 | Negative | | | | | Viewer C | BARC414 | 315 | Negative | | | | ## Buprenorphine | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer | Positive | 0 | 0 | 1 | 20 | 18 | | A | Negative | 5 | 18 | 16 | 2 | 0 | | Viewer | Positive | 0 | 0 | 0 | 20 | 18 | | B | Negative | 5 | 18 | 17 | 2 | 0 | | Viewer | Positive | 0 | 0 | 2 | 21 | 18 | | C | Negative | 5 | 18 | 15 | 1 | 0 | # Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|-------------------------------| | Viewer A | BUPC379 | 9.67 | Positive | | Viewer C | BUPC359 | 8.94 | Positive | | Viewer C | BUPC379 | 9.67 | Positive | | Viewer A | BUPC322 | 10.1 | Negative | | Viewer A | BUPC429 | 11.2 | Negative | | Viewer B | BUPC322 | 10.1 | Negative | | Viewer B | BUPC348 | 10.2 | Negative | | Viewer C | BUPC348 | 10.2 | Negative | ## Oxazepam | | | Low | Near Cutoff | Near Cutoff | | |--|----------|-------------|-------------|--------------|---------------| | | Negative | Negative by | Negative by | Positive by | High Positive | | | | LC/MS | LC/MS | LC/MS | by LC/MS | | | | (less than | (Between | (Between the | (greater than | | | | -50%) | -50% and | cutoff and | +50%) | | | | | cutoff) | +50%) | | {16}------------------------------------------------ | Viewer | | 0 | 0 | 2 | 20 | 18 | |--------|----------|---|----|----|----|----| | A | Positive | 0 | 0 | 2 | 20 | 18 | | | Negative | 5 | 15 | 18 | 2 | 0 | | Viewer | | 0 | 0 | 1 | 21 | 18 | | B | Positive | 0 | 0 | 1 | 21 | 18 | | | Negative | 5 | 15 | 19 | 1 | 0 | | Viewer | | 0 | 0 | 2 | 21 | 18 | | C | Positive | 0 | 0 | 2 | 21 | 18 | | | Negative | 5 | 15 | 18 | 1 | 0 | # Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | BZOC343 | 298 | Positive | | Viewer A | BZOC322 | 296 | Positive | | Viewer B | BZOC322 | 296 | Positive | | Viewer C | BZOC343 | 298 | Positive | | Viewer C | BZOC435 | 292 | Positive | | Viewer A | BZOC301 | 314 | Negative | | Viewer A | BZOC348 | 312 | Negative | | Viewer B | BZOC348 | 312 | Negative | | Viewer C | BZOC301 | 314 | Negative | # Cocaine | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------------------|----------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------| | Viewer | Positive | 0 | 0 | 2 | 21 | 19 | | A | Negative | 6 | 17 | 15 | 0 | 0 | | Viewer | Positive | 0 | 0 | 2 | 20 | 19 | | B | Negative | 6 | 17 | 15 | 1 | 0 | | Viewer | Positive | 0 | 0 | 1 | 20 | 19 | | C | Negative | 6 | 17 | 14 | 1 | 0 | | Discordant Results | | | | | | | ## Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|----------------------------| | Viewer A | COCC368 | 298 | Positive | | Viewer A | COCC340 | 294 | Positive | | Viewer B | COCC368 | 298 | Positive | | Viewer B | COCC315 | 282 | Positive | | Viewer C | COCC340 | 294 | Positive | | Viewer B | COCC317 | 301 | Negative | | Viewer C | COCC317 | 301 | Negative | Methylenedioxymethamphetamine {17}------------------------------------------------ | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer | Positive | 0 | 0 | 1 | 19 | 20 | | A | Negative | 5 | 16 | 18 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 19 | 20 | | B | Negative | 5 | 16 | 17 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 19 | 20 | | C | Negative | 5 | 16 | 17 | 1 | 0 | ## Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|-------------------------------| | Viewer A | MDMAC310 | 490 | Positive | | Viewer B | MDMAC306 | 497.5 | Positive | | Viewer B | MDMAC365 | 484.5 | Positive | | Viewer C | MDMAC310 | 490 | Positive | | Viewer C | MDMAC306 | 497.5 | Positive | | Viewer A | MDMAC316 | 505 | Negative | | Viewer B | MDMAC316 | 505 | Negative | | Viewer C | MDMAC484 | 565 | Negative | ## Methamphetamine | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------| | Viewer | Positive | 0 | 0 | 2 | 20 | 18 | | A | Negative | 5 | 16 | 17 | 2 | 0 | | Viewer | Positive | 0 | 0 | 1 | 21 | 18 | | B | Negative | 5 | 16 | 18 | 1 | 0 | | Viewer | Positive | 0 | 0 | 1 | 21 | 18 | | C | Negative | 5 | 16 | 18 | 1 | 0 | # Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|-------------------------------| | Viewer A | METC498 | 921 | Positive | | Viewer A | METC479 | 984 | Positive | | Viewer B | METC467 | 973 | Positive | | Viewer C | METC479 | 984 | Positive | | Viewer A | METC343 | 1020 | Negative | | Viewer A | METC473 | 1110 | Negative | | Viewer B | METC473 | 1110 | Negative | {18}------------------------------------------------ | Viewer C | METC343 | 1020 | Negative | |----------|---------|------|----------| |----------|---------|------|----------| ## Morphine | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |--------|----------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------| | Viewer | Positive | 0 | 0 | 2 | 18 | 21 | | A | Negative | 5 | 16 | 17 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 18 | 21 | | B | Negative | 5 | 16 | 17 | 1 | 0 | | Viewer | Positive | 0 | 0 | 2 | 17 | 21 | | C | Negative | 5 | 16 | 17 | 2 | 0 | ## Discordant Results | Viewer | Sample Number | LC/MS Result | BIOEASY Cup Viewer Results | |----------|---------------|--------------|-------------------------------| | Viewer A | MOPC355 | 287 | Positive | | Viewer A | MOPC429 | 298 | Positive | | Viewer B | MOPC408 | 286 | Positive | | Viewer B | MOPC429 | 298 | Positive | | Viewer C | MOPC408 | 286 | Positive | | Viewer C | MOPC433 | 276 | Positive | | Viewer A | MOPC393 | 301 | Negative | | Viewer B | MOPC416 | 339 | Negative | | Viewer C | MOPC416 | 339 | Negative | | Viewer C | MOPC393 | 301 | Negative | ## Methadone | | | Negative | Low Negative by LC/MS (less than -50%) | Near Cutoff Negative by LC/MS (Between -50% and cutoff) | Near Cutoff Positive by LC/MS (Between the cutoff and +50%) | High Positive by LC/MS (greater than +50%) | |----------|----------|----------|----------------------------------------|---------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------| | Viewer A | Positive | 0 | 0 | 2 | 21 | 18 | | Viewer A | Negative | 5 | 15 | 18 | 1 | 0 | | Viewer B | Positive | 0 | 0 | 2 | 20 | 18 | | Viewer B | Negative | 5 | 15 | 18 | 2 | 0 | | Viewer C | Positive | 0 | 0 | 3 | 22 | 18 | | Viewer C | Negative | 5…