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
Device Facts
| Record ID | K180878 |
|---|---|
| Device Name | 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 |
| Applicant | Shanghai Venture Bio-Tech Co., Ltd. |
| Product Code | DJC · Clinical Toxicology |
| Decision Date | Dec 17, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3610 |
| Device Class | Class 2 |
Intended 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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Drug Identifier Cut-off Level Amphetamine(AMP) 1000ng/mL Oxazepam 300 ng/mL Cocaine(COC) 300 ng/mL Marijuana(THC) 50 ng/mL Methamphetamine(MET) 1000 ng/mL Morphine 300 ng/mL The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use. 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 is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows: Drug Identifier Cut-off Level Amphetamine(AMP) 1000ng/mL Oxazepam 300 ng/mL Cocaine(COC) 300 ng/mL Marijuana(THC) 50 ng/mL Methamphetamine(MET) 1000 ng/mL Morphine 300 ng/mL The cassette test may be configured as single drug test in any drug analytes listed in the table. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for over-the-counter use.
Device Story
Lateral flow immunochromatographic assay; detects drugs of abuse in human urine. Cassette format houses single drug test strip. Principle: competitive binding; target drugs in urine compete with immobilized drug-conjugate for binding sites on gold-conjugated monoclonal antibodies. Absence of test line indicates positive result (drug concentration exceeds cutoff); presence of test line indicates negative result. Control line confirms proper migration. Used in clinical or home settings; operated by healthcare professionals or lay users. Provides preliminary results; requires confirmatory testing via GC/MS for clinical decision-making. Benefits: rapid, qualitative screening for drug presence.
Clinical Evidence
Bench testing only. Precision/reproducibility evaluated across 3 lots with 6 operators over 25 days. Analytical specificity (cross-reactivity and interference) and matrix effects (pH, specific gravity) demonstrated. Lay user study (n=840) confirmed ease of use and performance across diverse demographics. Method comparison against GC/MS performed for all analytes.
Technological Characteristics
Lateral flow immunochromatographic assay; mouse monoclonal antibodies on gold-conjugated nanoparticles; anti-IgG polyclonal antibody control line. Single-use cassette format. No external energy source. Stable at 2-30°C for 24 months.
Indications for Use
Indicated for qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH in human urine. Intended for prescription or over-the-counter use as a preliminary screening tool. Requires confirmatory testing (GC/MS).
Regulatory Classification
Identification
A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.
Special Controls
*Classification.* Class II (special controls). A methamphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) (k173303)
- INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) (k173303)
Related Devices
- K182530 — BIOEASY Multi-Drug Test Cup · Shenzhen Bioeasy Biotechnology Co., Ltd. · Nov 9, 2018
- K242540 — AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test Panel · Hangzhou AllTest Biotech Co., Ltd. · Sep 27, 2024
- K243996 — AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test Panel; AssureTech Multi-drug Urine Test Cup · Assure Tech., LLC · Feb 7, 2025
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image shows 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.
December 17, 2018
Shanghai Venture Bio-Tech CO., Ltd. % Ethan Liu, RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Floor 6, No.211, Xin Ling Road, Minhang District Shanghai. 201100 China
Re: k180878
Trade/Device Name: 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 Use BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use BIO-VENTURE Rapid Morphine Test Cassette for Rx Use BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC, LDJ, DKZ, JXM, NFT, DIO, NFY, NFV, NGG, DNK, NGI, NFW Dated: October 30, 2018 Received: November 5, 2018
Dear Ethan Liu:
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,
{1}------------------------------------------------
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 vou, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
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
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) k180878
#### Device Name
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
#### Indications for Use (Describe)
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 is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine.
Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|-----------------------|-------------------|---------------|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over the counter use.
| 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) | <div> </div> |
CONTINUE ON A SEPARATE PAGE IF NEEDED
|X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
{3}------------------------------------------------
### Indications for Use
in human urine. The test cut-off
510(k) Number (if known) k180878
#### Device Name
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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use
#### Indications for Use (Describe)
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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam,
Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|-----------------------|-------------------|---------------|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 100%;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 100%;"> <input type="checkbox"/> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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}------------------------------------------------
#### 510(k) Summary
K180878
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
#### 5.1 Submitter
| Submitted by: | SHANGHAI VENTURE BIO-TECH CO., LTD.<br>Room 313, Building 2, No. 2715 Longwu Road,<br>Xuhui District, Shanghai, China. |
|-----------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ethan Liu<br>Phone:0086-15216699240<br>Fax: 0086-21-60732022<br>Email:xtdeepwater@126.com |
| Date Prepared: | Dec 15, 2018 |
### 5.2 Device
#### 5.2.1 Trade Name
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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid
{5}------------------------------------------------
#### Marijuana Test Cassette for Rx Use
5.2.2 Classification:
| Product Code | CFR # | Panel |
|--------------|--------------------------------------------------------------------|------------|
| DKZ, NFT | 21 CFR, 862.3100<br>Amphetamine Test System | Toxicology |
| JXM, NFV | 21 CFR, 862.3170<br>Benzodiazepine Test<br>System | Toxicology |
| DIO, NFY | 21 CFR, 862.3250 Cocaine<br>and cocaine metabolite test<br>system. | Toxicology |
| DJC, NGG | 21 CFR, 862.3610<br>Methamphetamine Test<br>System | Toxicology |
| LDJ, NFW | 21 CFR, 862.3870<br>Cannabinoid Test System | Toxicology |
| DNK, NGI | 21 CFR, 862.3640<br>Morphine test system | Toxicology |
#### 5.3 Predicate Device
K173303
INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)
#### 5.4 Device Description
The 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 Use, BIO-
{6}------------------------------------------------
VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are immunochromatographic assays that use a lateral flow system for the qualitative detection of of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained
#### 5.5 Indication for Use:
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 is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|-----------------------|-------------------|---------------|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method.
Clinical consideration and professional judgment should be exercised with any drug of
{7}------------------------------------------------
abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for over the counter 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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in human urine. The test cutoff concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrators | Cut-off Level |
|-----------------------|-------------------|---------------|
| Amphetamine (AMP) | d-Amphetamine | 1000ng/ml |
| Oxazepam | Oxazepam | 300ng/ml |
| Cocaine (COC) | Benzoylecgonine | 300ng/ml |
| Methamphetamine (MET) | d-Methamphetamine | 1000ng/ml |
| Morphine(MOP) | Morphine | 300ng/ml |
| Marijuana (THC) | Delta-9-THC-COOH | 50ng/ml |
The cassette test may be configured as single drug test in any drug analytes listed in the table.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. The test is intended for prescription use.
### 5.6 Substantial Equivalence
A summary comparison of features of the BIO-VENTURE Rapid Amphetamine Test
{8}------------------------------------------------
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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use and the predicate devices is provided in following tables.
| Item | Device | Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | | Device-K173303 |
| Indication(s) for<br>Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Calibrator | d-Amphetamine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-off Values | 1000ng/mL | Same |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Cassette | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
| | Table 1: Features comparison of Amphetamine Tests and the Predicate Devices. | | | | | | |
|--|------------------------------------------------------------------------------|--|--|--|--|--|--|
| | | | | | | | |
Table 2: Features comparison of Cocaine Tests and the Predicate Devices.
{9}------------------------------------------------
| Item | Device | Predicate |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| | | Device-K173303 |
| Indication(s) for Use | For the qualitative determination of drugs of abuse in human urine. | Same |
| Calibrator | Cocaine | 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 |
| Cut-off Values | 300ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette | Cassette, Easy Cup, Split Key Cup and Dip Card |
Table 3: Features comparison of Oxazepam Tests and the Predicate Devices.
| Item | Device | Predicate<br>Device-K173303 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication(s) for<br>Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Calibrator | Oxazepam | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
{10}------------------------------------------------
| Cut-off Values | 300ng/mL | Same |
|----------------|------------------------------------------------|---------------------------------------------------------|
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Cassette | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
Table 4: Features comparison of Methamphetamine Tests and the Predicate Devices.
| Item | Device | Predicate<br>Device-K173303 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s) for<br>Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Calibrator | d-Methamphetamine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-off Values | 1000ng/mL | Same |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Cassette | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
Table 5: Features comparison of Morphine Tests and the Predicate Devices.
| Item | Device | Predicate |
|------|--------|-----------|
|------|--------|-----------|
{11}------------------------------------------------
| | | Device-K173303 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s) for<br>Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same |
| Calibrator | Morphine | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based<br>on the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Cut-off Values | 300ng/mL | 2000ng/mL |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Cassette | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
Table 6: Features comparison of Marijuana Tests and the Predicate Devices.
| Item | Device | Predicate<br>Device-K173303 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs<br>of abuse in human urine. | Same |
| Calibrator | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen<br>Type | Human Urine | Same |
{12}------------------------------------------------
| Cut-off Values | 50ng/mL | Same |
|----------------|---------------------------------------------|---------------------------------------------------------|
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Cassette | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
#### 5.7 Test Principle
The 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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are rapid tests for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH 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 antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff concentration because it will saturate all the binding sites of the antibody coated on the particles.
A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.
#### 5.8 Performance Characteristics
#### 5.8.1 Analytical Performance
#### a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off and +100% cut off, These
{13}------------------------------------------------
samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Each concentration has three lots, and 6 operators have joined the performance. Each operator performs 9 samples for 25days per device in a randomized order. The results obtained are summarized in the following tables.
#### AMP Assay
| Lot Number | - | -75% | -50% | -25% | Cut off | 25% | 50% | 75% | 100% |
|-------------------|-----------------|------------|------------|------------|-------------|------------|------------|------------|------------|
| | 100%<br>cut off | cut off | cut off | cut off | | cut off | Cut<br>off | cut off | cut off |
| AMP2-<br>10010301 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 28-<br>/22+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| AMP2-<br>10010302 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 26-<br>/24+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| AMP2-<br>10010303 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 26-<br>/24+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
#### COC Assay
| Lot Number | | -75% | -50% | -25% | Cut off | 25% | 50% | 75% | 100% |
|-------------------|-----------------|------------|------------|------------|-------------|------------|------------|------------|------------|
| | 100%<br>cut off | cut off | cut off | cut off | | cut off | Cut<br>off | cut off | cut off |
| COC2-<br>10110301 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 27-<br>/23+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| COC2-<br>10110302 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 24-<br>/26+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
{14}------------------------------------------------
| COC2-<br>10110303 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 26-<br>/24+ | 50+/0 | 50+/0 | 50+/0 | 50+/0 |
|-------------------|------------|------------|------------|------------|-------------|-------|-------|-------|-------|
| | | | | | | - | - | - | - |
## Oxazepam Assay
| Lot Number | -100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cut off | Cut off | 25%<br>cut off | 50%<br>Cut off | 75%<br>cut off | 100%<br>cut off |
|-------------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| BZO2-<br>10111601 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| BZO2-<br>10111602 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| BZO2-<br>10111603 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## MET Assay
| Lot Number | - | -75%<br>cut off | -50%<br>cut off | -25%<br>cut off | Cut off | 25%<br>cut off | 50%<br>Cut off | 75%<br>cut off | 100%<br>cut off |
|-----------------|-----------------|-----------------|-----------------|-----------------|-------------|----------------|----------------|----------------|-----------------|
| | 100%<br>cut off | | | | | | | | |
| GA00040800<br>4 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 10-<br>/40+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| GA00040800<br>5 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 9-/41+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| GA00040800<br>6 | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 50-<br>/0+ | 10-<br>/40+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
{15}------------------------------------------------
#### MOP Assay
| Lot Number | -<br>100%<br>cut off | -75%<br>cut off | -50%<br>cut off | -25%<br>cut off | Cut off | 25%<br>cut off | 50%<br>Cut<br>off | 75%<br>cut off | 100%<br>cut off |
|-----------------|----------------------|-----------------|-----------------|-----------------|-------------|----------------|-------------------|----------------|-----------------|
| GA00020800<br>1 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 17-/<br>33+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| GA00020800<br>2 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 19-/<br>31+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| GA00020800<br>3 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 15-/<br>35+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
### THC Assay
| Lot Number | -<br>100%<br>cut<br>off | -75%<br>cut<br>off | -50%<br>cut<br>off | -25%<br>cut<br>off | Cut off | 25%<br>cut<br>off | 50%<br>Cut<br>off | 75%<br>cut<br>off | 100%<br>cut<br>off |
|-------------------|-------------------------|--------------------|--------------------|--------------------|-------------|-------------------|-------------------|-------------------|--------------------|
| THC2-<br>10110901 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 36-/<br>14+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| THC2-<br>10110902 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 38-/<br>12+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
| THC2-<br>10110903 | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 50-/<br>0+ | 35-/<br>15+ | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- | 50+/0<br>- |
## b. Linearity
Not applicable
## c. Stability
The devices are stable at 2-30 ℃ for 24 months based on the real time stability study at room temperature.
{16}------------------------------------------------
### d. Cut-off
A total of 125 samples equally distributed at concentrations of -50% Cut-Off; -25% Cut-Off; Cut-Off; +25% Cut-Off; +50% Cut-Off were tested using three different lots of each device by three different operators. Results were all positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine and Marijuana.
The following cut-off values for the candidate devices have been verified.
| Calibrator | Cut-off(ng/mL) |
|-------------------------------------------|----------------|
| d-Amphetamine | 1000 |
| Benzoylecgonine | 300 |
| Oxazepam | 300 |
| d-Methamphetamine | 1000 |
| Morphine | 300 |
| (-)-11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 |
### e. 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 and Ethanol at 1% are summarized in the following tables.
### AMP Assay
| Methadone | Naltrexone | Naloxone | Morphine |
|--------------|-------------|------------------|-----------------------------|
| Gatifloxacin | Procaine | Amitriptyline | Chlorpheniramine<br>Maleate |
| Promethazine | Amoxicillin | Methoxyphenamine | Ketamine<br>Hydrochloride |
| Ranitidine | Tramadol | Buprenorphine | Phenobarbital |
| Nifedipine | Diazepam | Dextromethorphan | Cocaine |
| Theophylline | Aspirin | Acetaminophen | Δ9-THC |
{17}------------------------------------------------
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
|-------------------------|---------------|----------------|---------------|
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone<br>acetate | Cholesterol | Hydrocortisone | Oxycodone |
| Ethanol | | | |
## Oxazepam Assay
| Methadone | Naltrexone | Naloxone | Morphine |
|-------------------------|-----------------------------|----------------|-----------------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine<br>Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Cocaine | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| MDMA | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone<br>acetate | Cholesterol | Amphetamine | Ethanol |
## COC Assay
| Methadone | Naltrexone | Naloxone | Morphine |
|-----------|------------------|--------------|----------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
{18}------------------------------------------------
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
|------------------|-----------------------------|----------------|-------------------------|
| Methoxyphenamine | Ketamine<br>Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Secobarbital | Angiotensin | Adrenaline | Oxalic Acid |
| Oxazepam | Uric Acid | Triglyceride | Prednisolone<br>acetate |
| Cholesterol | MDMA | Amphetamine | Ethanol |
### MET Assay
| Methadone | Naltrexone | Naloxone | Morphine |
|------------------|-----------------------------|----------------|---------------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine<br>Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Diazepam |
| Dextromethorphan | Cocaine | Theophylline | Aspirin |
| Acetaminophen | Δ9-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
{19}------------------------------------------------
| Prednisolone | Cholesterol | Ethanol | |
|--------------|-------------|---------|--|
| acetate | | | |
# MOP Assay
| Methadone | Naltrexone | Naloxone | Cocaine |
|-------------------------|-----------------------------|--------------|-----------------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine<br>Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
| Acetaminophen | Δ⁹-THC | Cholesterol | Hydrocortisone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone<br>acetate | Amphetamine | MDMA | Ethanol |
# THC Assay
| Methadone | Naltrexone | Naloxone | Morphine |
|------------------|-----------------------------|--------------|-----------------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine<br>Hydrochloride | Ranitidine | Tramadol |
| Buprenorphine | Phenobarbital | Nifedipine | Methamphetamine |
| Dextromethorphan | Diazepam | Theophylline | Aspirin |
{20}------------------------------------------------
| Acetaminophen | Cocaine | Amphetamine | MDMA |
|-------------------------|---------------|----------------|---------------|
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
| Propoxyphene | Aminopyrine | Cotinine | Fentanyl |
| Benzoylecgonine | Secobarbital | Angiotensin | Adrenaline |
| Oxazepam | Uric Acid | Triglyceride | Oxalic Acid |
| Prednisolone<br>acetate | Cholesterol | Hydrocortisone | Oxycodone |
| Ethanol | | | |
### f. 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. There were no differences observed for different devices.
#### AMP Assay:
| Drugs | Concentration(ng/mL) | %Cross Reactivity |
|------------------------------------------|----------------------|-------------------|
| D-Amphetamine | 1000 | 100% |
| D/L- Amphetamine | 1500 | 66.7% |
| Phentermine | 3000 | 33.3% |
| L-Amphetamine | 3000 | 33.3% |
| Hydroxyamphetamine | 10000 | 10% |
| Methylenedioxyamphetamine(MDA) | 10000 | 10% |
| 3,4-methylenedioxy-methamphetamine(MDMA) | >100,000 | <1% |
| Methylenedioxyethylamphetamine(MDE) | >100,000 | <1% |
| Ephedrine | >100,000 | <1% |
| Pseudophedrine | >100,000 | <1% |
| D-Methamphetamine | >100,000 | <1% |
{21}------------------------------------------------
| D/L-Methamphetamine | >100,000 | <1% |
|---------------------|----------|-----|
|---------------------|----------|-----|
## COC Assay
| Drugs | Concentration(ng/mL) | %Cross Reactivity |
|-----------------|----------------------|-------------------|
| Cocaine HCl | 5000 | 6% |
| Norcocaine | 25000 | 1.2% |
| Ecgonine HCl | 50000 | 0.6% |
| Cocaethylene | >100000 | <0.3% |
| Benzoylecgonine | 300 | 100% |
## Oxazepam Assay
| Drugs | Concentration(ng/mL) | %Cross Reactivity |
|---------------------|----------------------|-------------------|
| Oxazepam | 300 | 100% |
| Diazepam | 1000 | 30% |
| Alprazolam | 1000 | 30% |
| α-Hydroxyalprazolam | 5000 | 6% |
| Bromazepam | 10000 | 3% |
| Chlordiazepoxide | 10000 | 3% |
| Clobazam | 500 | 60% |
| Clonazepam | 3000 | 10% |
| Delorazepam | 5000 | 6% |
| Estazolam | 10000 | 3% |
| Flunitrazepam | 5000 | 6% |
| Midazolam | 50000 | 0.6% |
| Nitrazepam | 500 | 60% |
| Nordiazepam | 5000 | 6% |
{22}------------------------------------------------
| Temazepam | 500 | 60% |
|-------------------------|----------|-------|
| Triazolam | 10000 | 3% |
| Lorazepam | 25000 | 1.2% |
| Clorazepate Dipotassium | > 100000 | <0.3% |
| Desalkylflurazepam | > 100000 | <0.3% |
| Norchlordiazepoxide | > 100000 | <0.3% |
## MET Assay
| Drugs | Concentration(ng/mL) | % Cross<br>Reactivity |
|----------------------------------------------------|----------------------|-----------------------|
| (±)3,4-methylenedioxy-n-<br>ethylamphetamine(MDEA) | 5000 | 20% |
| D-Methamphetamine | 1000 | 100% |
| L-Methamphetamine | 10000 | 10% |
| D/L- Methamphetamine | 3000 | 33.3% |
| p-Hydroxymethamphetamine | 50000 | 2% |
| (±)3,4-<br>Methylenedioxyamphetamine(MDA) | 20000 | 5% |
| (±)3,4-<br>Methylenedioxymethamphetamine(MDM<br>A) | 3000 | 33.3% |
| D/L-Amphetamine | >100,000 | <1% |
| D- Amphetamine | >100,000 | <1% |
| L-Amphetamine | >100,000 | <1% |
MOP Assay
{23}------------------------------------------------
| Drugs | Concentration | % Cross<br>Reactivity |
|-------------------------|---------------|-----------------------|
| Acetylmorphine | 6000 | 5% |
| Hydromorphone | 3000 | 10% |
| Hydrocodone | 50000 | 0.6% |
| Levorphanol | 1500 | 20% |
| Oxycodone | 50000 | 0.6% |
| Dimethylmorphine | 3000 | 10% |
| Morphine-3- Glucuronide | >100,000 | <0.3% |
| Morphine | 300 | 100% |
| Codeine | 300 | 100% |
| Heroin | 300 | 100% |
| O6- Monoacetylmorphine | 300 | 100% |
| Ethylmorphine | >100000 | <0.3% |
## THC Assay
| Drugs | Concentration | % Cross<br>Reactivity |
|-------------------------------------------|---------------|-----------------------|
| (-)-11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 50 | 100% |
| 11-Hydroxy-Δ9-Tetrahydrocannabinol | 10000 | 0.5% |
| 11- Nor-△8-Tetrahydrocannabinol-9-COOH | 2500 | 2% |
| Cannabinol | 5000 | 1% |
{24}------------------------------------------------
| 11-Nor-∆9-THC-carboxy glucuronide | 5000 | 1% |
|-----------------------------------|--------|-------|
| (-)-11-nor-9-carboxy-∆9-THC | 10000 | 0.5% |
| ∆8- Tetrahydrocannabinol | >50000 | <0.1% |
| ∆9- Tetrahydrocannabinol | >50000 | <0.1% |
| Cannabidiol | >50000 | <0.1% |
### g. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.002 to 1.036 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% Cutoff and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
#### 5.8.2. Comparison Studies
Method comparison studies for the 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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use were performed in-house with three laboratory assistants for each device. Operators ran unaltered clinical samples, 87 samples for amphetamine, 80 samples for cocaine, 80 samples for Oxazepam, 81 samples for Methamphetamine, 81 samples for Morphine, 82 samples for Marijuana. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:
#### Amphetamine
| Cassette | Negative | <-50% cut | -50% cut | Cut<br>off~+50%cut | >+50% cut |
|----------|----------|-----------|----------|--------------------|-----------|
|----------|----------|-----------|----------|--------------------|-----------|
{25}------------------------------------------------
| | | | off | off~cut off | off | off |
|------------|----------|----|-----|-------------|-----|-----|
| Operator 1 | Negative | 19 | 16 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 27 |
| Operator 2 | Negative | 19 | 16 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 13 | 27 |
| Operator 3 | Negative | 19 | 16 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 14 | 27 |
## Discordant Results of Amphetamine Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 989 | Negative |
| 2 | 989 | Positive |
| 3 | 989 | Positive |
| 1 | 1035 | Positive |
| 2 | 1035 | Negative |
| 3 | 1035 | Positive |
| 1 | 1062 | Negative |
| 2 | 1062 | Positive |
| 3 | 1062 | Positive |
## Cocaine
| Cassette | | Negative | <-50% cut<br>off | -50% cut<br>off~cut off | Cut<br>off~+50%cut<br>off | >+50% cut<br>off |
|------------|----------|----------|------------------|-------------------------|---------------------------|------------------|
| Operator 1 | Negative | 18 | 13 | 11 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 17 | 21 |
| Operator 2 | Negative | 18 | 13 | 9 | 0 | 0 |
| | Positive | 0 | 0 | 2 | 17 | 21 |
{26}------------------------------------------------
| Operator 3 | Negative | 18 | 13 | 9 | 0 | 0 |
|------------|----------|----|----|---|----|----|
| | Positive | 0 | 0 | 2 | 17 | 21 |
## Discordant Results of Cocaine Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 278 | Negative |
| 2 | 278 | Positive |
| 3 | 278 | Positive |
| 1 | 285 | Negative |
| 2 | 285 | Positive |
| 3 | 285 | Positive |
## Oxazepam
| Cassette | | Negative | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+50% cut off |
|------------|----------|----------|---------------|----------------------|---------------------|---------------|
| Operator 1 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
| Operator 2 | Negative | 15 | 10 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 2 | 20 | 20 |
| Operator 3 | Negative | 15 | 10 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 2 | 20 | 20 |
### Discordant Results of Oxazepam Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 283 | Negative |
| 2 | 283 | Positive |
| 3 | 283 | Negative |
{27}------------------------------------------------
| 1 | 288 | Negative |
|---|-----|----------|
| 2 | 288 | Positive |
| 3 | 288 | Positive |
| 1 | 298 | Negative |
| 2 | 298 | Negative |
| 3 | 298 | Positive |
## Methamphetamine
| Cassette | | Negative | <-50% cut<br>off | -50% cut<br>off~cut off | Cut<br>off~+50%cut<br>off | >+50% cut<br>off |
|------------|----------|----------|------------------|-------------------------|---------------------------|------------------|
| Operator 1 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
| Operator 2 | Negative | 17 | 16 | 8 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 8 | 29 |
| Operator 3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
## Discordant Results of Methamphetamine Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 1025 | Positive |
| 2 | 1025 | Negative |
| 3 | 1025 | Positive |
| 1 | 1033 | Positive |
| 2 | 1033 | Negative |
| 3 | 1033 | Positive |
| 1 | 984 | Positive |
{28}------------------------------------------------
| 2 | 984 | Negative |
|---|------|----------|
| 3 | 984 | Positive |
| 1 | 1055 | Positive |
| 2 | 1055 | Negative |
| 3 | 1055 | Positive |
# Morphine
| Cassette | | Negative | <-50% cut<br>off | -50% cut<br>off~cut off | Cut<br>off~+50%cut<br>off | >+50% cut<br>off |
|------------|----------|----------|------------------|-------------------------|---------------------------|------------------|
| Operator 1 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
| Operator 2 | Negative | 19 | 9 | 13 | 3 | 0 |
| | Positive | 0 | 0 | 0 | 12 | 25 |
| Operator 3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
## Discordant Results of Morphine Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 323 | Positive |
| 2 | 323 | Negative |
| 3 | 323 | Positive |
| 1 | 335 | Positive |
| 2 | 335 | Negative |
| 3 | 335 | Positive |
| 1 | 293 | Positive |
| 2 | 293 | Negative |
| 3 | 293 | Positive |
{29}------------------------------------------------
| 1 | 325 | Positive |
|---|-----|----------|
| 2 | 325 | Negative |
| 3 | 325 | Positive |
## Marijuana
| Cassette | | Negative | <-50% cut off | -50% cut off~cut off | Cut off~+50%cut off | >+50% cut off |
|------------|----------|----------|---------------|----------------------|---------------------|---------------|
| Operator 1 | Negative | 18 | 11 | 13 | 4 | 0 |
| | Positive | 0 | 0 | 0 | 12 | 24 |
| Operator 2 | Negative | 18 | 11 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 24 |
| Operator 3 | Negative | 18 | 11 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 15 | 24 |
# Discordant Results of Marijuana Cassette
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 61 | Negative |
| 2 | 61 | Positive |
| 3 | 61 | Positive |
| 1 | 59 | Negative |
| 2 | 59 | Positive |
| 3 | 59 | Negative |
| 1 | 61 | Negative |
| 2 | 61 | Positive |
| 3 | 61 | Positive |
| 1 | 59 | Negative |
| 2 | 59 | Positive |
{30}------------------------------------------------
| | CO<br>2 | Positive |
|---|---------|----------|
| 3 | 59 | Positive |
#### Lay-user study
A lay user study was performed at three intended user sites for 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 Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use separately. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at the following concentrations; negative. +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested.
| % of cut off | Number of samples | d-Amphetamine Concentration by GC/MS(ng/mL) | Number Positive | Number Negative | Percentage of Correct Results (%) |
|---------------|-------------------|---------------------------------------------|-----------------|-----------------|-----------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 248 | 0 | 20 | 100% |
| -50% cut off | 20 | 492 | 0 | 20 | 100% |
| -25% cut off | 20 | 741 | 2 | 18 | 90% |
| +25% cut off | 20 | 1262 | 19 | 1 | 95% |
| +50% cut off | 20 | 1506 | 20 | 0 | 100% |
| +75% cut off | 20 | 1744 | 20 | 0 | 100% |
{31}------------------------------------------------
| % of cut off | Number of<br>samples | Cocaine<br>Concentration<br>by<br>GC/MS(ng/m<br>L) | Number of<br>Positive | Number of<br>Negative | Percentage of<br>Correct<br>Results(%) |
|---------------|----------------------|----------------------------------------------------|-----------------------|-----------------------|----------------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 62 | 0 | 20 | 100% |
| -50% cut off | 20 | 135 | 0 | 20 | 100% |
| -25% cut off | 20 | 212 | 2 | 18 | 90% |
| +25% cut off | 20 | 365 | 20 | 0 | 100% |
| +50% cut off | 20 | 444 | 20 | 0 | 100% |
| +75% cut off | 20 | 533 | 20 | 0 | 100% |
## Comparison between GC/MS and Lay Person Results for Cocaine Cassette
## Comparison between GC/MS and Lay Person Results for Oxazepam Cassette
| % of cut off | Number of<br>samples | Oxazepam<br>Concentration<br>by<br>GC/MS(ng/m<br>L) | Number of<br>Positive | Number of<br>Negative | Percentage of<br>Correct<br>Results(%) |
|---------------|----------------------|-----------------------------------------------------|-----------------------|-----------------------|----------------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 64 | 0 | 20 | 100% |
| -50% cut off | 20 | 141 | 0 | 20 | 100% |
| -25% cut off | 20 | 221 | 1 | 19 | 95% |
| +25% cut off | 20 | 362 | 20 | 0 | 100% |
| +50% cut off | 20 | 440 | 20 | 0 | 100% |
| +75% cut off | 20 | 530 | 20 | 0 | 100% |
{32}------------------------------------------------
г
| % of cut off | Number of samples | d-Methamphetamine Concentration by GC/MS(ng/mL) | Number Positive | Number Negative | Percentage of Correct Results (%) |
|---------------|-------------------|-------------------------------------------------|-----------------|-----------------|-----------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 248 | 0 | 20 | 100% |
| -50% cut off | 20 | 489 | 0 | 20 | 100% |
| -25% cut off | 20 | 734 | 2 | 18 | 90% |
| +25% cut off | 20 | 1284 | 20 | 0 | 100% |
| +50% cut off | 20 | 1535 | 20 | 0 | 100% |
| +75% cut off | 20 | 1783 | 20 | 0 | 100% |
## Comparison between GC/MS and Lay Person Results for Methamphetamine Cassette
Comparison between GC/MS and Lay Person Results for Morphine Cassette
| % of cut off | Number of<br>samples | Morphine<br>Concentration<br>by<br>GC/MS(ng/m<br>L) | Number of<br>Positive | Number of<br>Negative | Percentage of<br>Correct<br>Results(%) |
|---------------|----------------------|-----------------------------------------------------|-----------------------|-----------------------|----------------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 70 | 0 | 20 | 100% |
| -50% cut off | 20 | 136…
