BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
Device Facts
| Record ID | K180879 |
|---|---|
| Device Name | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use |
| Applicant | Shanghai Venture Bio-Tech Co., Ltd. |
| Product Code | DKZ · Clinical Toxicology |
| Decision Date | Dec 14, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3100 |
| Device Class | Class 2 |
Intended Use
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, 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 Easy cup test and Split Key Cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes. 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. BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay 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 Easy cup test and split key cup test may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes. 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.
Device Story
Lateral flow immunochromatographic assay; detects d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine, and Delta-9-THC-COOH in human urine. Urine sample migrates via capillary action; target drugs compete with drug-conjugates for binding sites on monoclonal mouse antibody-coated particles. Absence of drug allows antibody-particle binding to immobilized drug-conjugate, forming visible colored test line; presence of drug saturates binding sites, preventing line formation. Control line confirms proper flow. Used in OTC or clinical settings; operated by lay users or healthcare professionals. Provides preliminary qualitative results; positive results require confirmation via GC/MS. Benefits patient by enabling rapid, point-of-care screening for drug presence.
Clinical Evidence
No clinical trials performed. Evidence consists of analytical bench testing (precision, cross-reactivity, interference) and a lay user study (n=280) comparing device results to GC/MS-confirmed spiked urine samples. Results showed high concordance with GC/MS across all analytes at concentrations near the cutoff.
Technological Characteristics
Lateral flow immunochromatographic assay; qualitative; urine specimen; monoclonal mouse antibody-coated particles; immobilized drug-conjugate test lines; internal control line; shelf life 24 months at 2-30°C; no external controls provided; no instrumentation required.
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 OTC or prescription use to provide preliminary results; requires confirmatory testing (GC/MS).
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
- 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
- K162395 — MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test Cup · Mp Biomedicals, LLC · Jun 2, 2017
- K123080 — CHEMTRUE SINGLE/MULTI-PANEL DRUG SCREEN DIP CARD/ CASSETTE TESTS · Chemtron Biotech, Inc. · Nov 29, 2012
- K051966 — FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY · Worldwide Medical, LLC · Sep 7, 2005
- K050878 — ON CALL MULTI-DRUG HOME TEST CUP · ACON Laboratories, Inc. · Jun 8, 2005
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
December 14, 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: k180879
Trade/Device Name: BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, JXM, NFT, DIO, NFY, NFV, DJC, NGG, DNK, NGL, LDJ, 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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4. Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (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).
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)
#### k180879
#### Device Name
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use
#### Indications for Use (Describe)
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use is a rapid lateral flow immunoassay for the qualitative detection of d-Amphetamine, Oxazepan, 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 |
Easy cup test and Split Key Cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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) |
#### 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
#### 510(k) Number (if known) k180879
#### Device Name
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
#### Indications for Use (Describe)
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is a rapid lateral flow immunoasay 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 |
Easy cup test and split key cup test may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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>Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|---------------------------------------------------------------------------|
| <div> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </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
#### K180879
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 |
| | Phone: 0086-15216699240 |
| | Fax: 0086-21-60732022 |
| | Email: xtdeepwater@126.com |
| Date Prepared: | Dec 14, 2018 |
#### 5.2 Device
5.2.1 Trade name
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use
5.2.2 Classification
| Product Code | CFR # | Panel |
|--------------|-------|-------|
|--------------|-------|-------|
5-1
{5}------------------------------------------------
| DKZ, NFT | 21 CFR, | 862.3100 | Toxicology<br>Amphetamine Test System |
|----------|---------|----------|--------------------------------------------------------------|
| JXM, NFV | 21 CFR, | 862.3170 | Toxicology<br>Benzodiazepine Test<br>System |
| DIO, NFY | 21 CFR, | 862.3250 | Toxicology<br>Cocaine and cocaine metabolite test<br>system. |
| DJC, NGG | 21 CFR, | 862.3610 | Toxicology<br>Methamphetamine Test<br>System |
| LDJ, NFW | 21 CFR, | 862.3870 | Toxicology<br>Cannabinoid Test System |
| DNK, NGI | 21 CFR, | 862.3640 | Toxicology<br>Morphine test system |
#### 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
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use is immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and 11-Nor-A9-Tetrahydrocannabinol-9-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.
{6}------------------------------------------------
#### 5.5 Indication for Use
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup 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 |
Easy cup test and Split key cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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.
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup 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 |
{7}------------------------------------------------
| 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 |
Easy cup test and Split key cup test may be configured as single drug tests or multiple drug tests in any combination of the drug analytes listed in the table above up to a maximum of 6 analytes.
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 Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use and the predicate devices is provided in following tables.
| 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-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 |
Table 1: Features comparison of Amphetamine Tests and the Predicate Devices.
{8}------------------------------------------------
| Specimen Type | Human Urine | Same |
|----------------|------------------------------------------------|---------------------------------------------------------|
| Cut-off Values | 1000ng/mL | Same |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Easy Cup and Split Key Cup | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
Table 2: Features comparison of Cocaine Tests and the Predicate Devices.
| 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 | Easy Cup and Split Key Cup | Cassette, Easy Cup, Split Key Cup and Dip Card |
Table 3: Features comparison of Oxazepam Test Kits and the Predicate Devices.
{9}------------------------------------------------
| 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 |
| Cut-off Values | 300ng/mL | Same |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Easy Cup and Split Key Cup | 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 |
{10}------------------------------------------------
| Specimen Type | Human Urine | Same |
|----------------|------------------------------------------------|---------------------------------------------------------|
| Cut-off Values | 1000ng/mL | Same |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Easy Cup and Split Key Cup | 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 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | | 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 | 2000 ng/mL |
| Intended Use | For over-the-counter and prescription<br>uses. | Same |
| Configurations | Easy Cup and Split Key Cup | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
Table 6: Features comparison of Marijuana Tests and the Predicate Devices.
{11}------------------------------------------------
| Item | Device | Predicate |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | | 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 |
| Cut-off Values | 50ng/mL | Same |
| Intended Use | For over-the-counter and prescription uses. | Same |
| Configurations | Easy Cup and Split Key Cup | Cassette, Easy<br>Cup, Split Key<br>Cup and Dip<br>Card |
#### 5.7 Test Principle
BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use are rapid tests for the qualitative detection of d-Amphetamine, Oxazepam, d-Methamphetamine, Morphine Benzoylecgonine, 11-Nor-49-Tetrahydrocannabinol-9-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
{12}------------------------------------------------
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 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 25 days per device in a randomized order. The results obtained are summarized in the following tables.
#### AMP Assay
| Batch | -100% | -75% | -50% | -25% | Cut off | 25% | 50% | 75% | 100% |
|-----------|---------|---------|---------|---------|---------|---------|------------|---------|---------|
| Number | cut off | cut off | cut off | cut off | | cut off | Cut<br>off | cut off | cut off |
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
#### Split Key Cup
Easy Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{13}------------------------------------------------
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- |
|----------|--------|--------|--------|--------|---------|--------|--------|--------|
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- |
# COC Assay
Split Key Cup
| Batch | -100% | -75% | -50% | -25% | Cut off | 25% | 50% | 75% | 100% |
|-----------|---------|---------|---------|---------|---------|---------|------------|---------|---------|
| Number | cut off | cut off | cut off | cut off | | cut off | Cut<br>off | cut off | cut off |
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Easy Cup
| Batch<br>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<br>off | 75%<br>cut off | 100%<br>cut off |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|-------------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Oxazepam Assay
Split Key Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{14}------------------------------------------------
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- |
|-----------|--------|--------|--------|--------|---------|--------|--------|--------|
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- |
Easy Cup
| Batch<br>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<br>off | 75%<br>cut off | 100%<br>cut off |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|-------------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# MET Assay
Split Key Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 9-/41+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 11-/39+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Easy Cup
| Batch<br>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<br>off | 75%<br>cut off | 100%<br>cut off |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|-------------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{15}------------------------------------------------
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 10-/40+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|----------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 12-/38+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# MOP Assay
Split Key Cup
| Batch | -100% | -75% | -50% | -25% | Cut off | 25% | 50% | 75% | 100% |
|-----------|---------|---------|---------|---------|---------|---------|------------|---------|---------|
| Number | cut off | cut off | cut off | cut off | | cut off | Cut<br>off | cut off | cut off |
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# Easy Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 19-/31+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
# THC Assay
Split Key Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| C11100064 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 36-/14+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
{16}------------------------------------------------
| C11100065 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38-/12+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
|-----------|--------|--------|--------|--------|---------|--------|--------|--------|--------|
| C11100066 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 35-/15+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Easy Cup
| Batch<br>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 |
|-----------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| 11100061 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 36-/14+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100062 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 38-/12+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 11100063 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 35-/15+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## b. Linearity
Not applicable
## c. Stability
The devices are stable at 2-30 ℃ for 24 months based on the real time stability at room temperature.
# d. Cut-off
A total of 375 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 |
{17}------------------------------------------------
| Cocaine | 300 |
|----------------------------------------------------|------|
| Oxazepam | 300 |
| d-Methamphetamine | 1000 |
| Morphine | 300 |
| (-)-11-Nor- $\Delta$ 9-Tetrahydrocannabinol-9-COOH | 50 |
#### Interference e.
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 | $Δ9-THC$ |
| 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 | | | |
{18}------------------------------------------------
| 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 | Δ²-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 |
# Oxazepam Assay
# COC 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 |
| Acetaminophen | Δ⁹-THC | Hydrocortisone | Oxycodone |
| Ascorbic Acid | Hemoglobin | Bilirubin | Ibuprofen |
| Dolantin | Hydroxyketone | EDDP | Phencyclidine |
{19}------------------------------------------------
| 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 |
| Prednisolone<br>acetate | Cholesterol | Ethanol | |
# MOP Assay
| Methadone | Naltrexone | Naloxone | Cocaine |
|------------------|-----------------------------|--------------|-------------|
| Ephedrine | Pseudo Ephedrine | Gatifloxacin | Procaine |
| Amitriptyline | Chlorpheniramine<br>Maleate | Promethazine | Amoxicillin |
| Methoxyphenamine | Ketamine | Ranitidine | Tramadol |
{20}------------------------------------------------
| | Hydrochloride | | |
|----------------------|--------------------------------|--------------|-----------------|
| 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 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 |
| 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 | | | |
{21}------------------------------------------------
## 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 is 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% |
| L-Methamphetamine | >100,000 | <1% |
| 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% |
{22}------------------------------------------------
| 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% |
| 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
{23}------------------------------------------------
| 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(MDMA) | 3000 | 33.3% |
| D/L-Amphetamine | >100,000 | <1% |
| D- Amphetamine | >100,000 | <1% |
| L-Amphetamine | >100,000 | <1% |
# MOP Assay
| Drugs | Concentration | %Cross<br>Reactivity |
|----------------|---------------|----------------------|
| Acetylmorphine | 6000 | 5% |
| Hydromorphone | 3000 | 10% |
| Hydrocodone | 50000 | 0.6% |
| Levorphanol | 1500 | 20% |
{24}------------------------------------------------
| 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-Δ8-Tetrahydrocannabinol-9-COOH | 2500 | 2% |
| Cannabinol | 5000 | 1% |
| 11-Nor-Δ9-THC-carboxy glucuronide | 5000 | 1% |
| (-)-11-nor-9-carboxy-Δ9-THC | 10000 | 0.5% |
| Δ8- Tetrahydrocannabinol | >50000 | <0.1% |
| Δ9- Tetrahydrocannabinol | >50000 | <0.1% |
| Cannabidiol | >50000 | <0.1% |
g. Effect of Urine Specific Gravity and Urine pH
{25}------------------------------------------------
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 Study
Method comparison studies for BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup 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
| Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut off-<br>+50% cut off | >+50% cut<br>off |
|---------------|----------|-------------------|------------------|--------------------------|--------------------------|------------------|
| Operator<br>1 | Negative | 19 | 16 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 27 |
| Operator<br>2 | Negative | 19 | 16 | 10 | 1 | 0 |
| | Positive | 0 | 0 | 1 | 13 | 27 |
| Operator<br>3 | Negative | 19 | 16 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 14 | 27 |
#### Discordant Results of Amphetamine Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 989 | Negative |
| 2 | 989 | Positive |
| 3 | 989 | Positive |
| 1 | 1035 | Positive |
{26}------------------------------------------------
| 2 | 1035 | Negative |
|---|------|----------|
| 3 | 1035 | Positive |
| 1 | 1062 | Negative |
| 2 | 1062 | Positive |
| 3 | 1062 | Positive |
| Split<br>Key Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut off-<br>+50% cut off | >+50% cut<br>off |
|------------------|----------|-------------------|------------------|--------------------------|--------------------------|------------------|
| Operator<br>1 | Negative | 19 | 16 | 11 | 1 | 0 |
| Operator<br>1 | Positive | 0 | 0 | 0 | 13 | 27 |
| Operator<br>2 | Negative | 19 | 16 | 10 | 1 | 0 |
| Operator<br>2 | Positive | 0 | 0 | 1 | 13 | 27 |
| Operator<br>3 | Negative | 19 | 16 | 10 | 0 | 0 |
| Operator<br>3 | Positive | 0 | 0 | 1 | 14 | 27 |
# Discordant Results of Amphetamine Split Key Cup
| 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
| Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut<br>off | Cut off-<br>+50% cut off | >+50% cut<br>off |
|-----|---------|-------------------|------------------|-----------------|--------------------------|------------------|
| | | | | | | |
{27}------------------------------------------------
| Operator | | Negative | 18 | 13 | 11 | 2 | 0 |
|---------------|----------|----------|----|----|----|----|---|
| | Positive | 0 | 0 | 0 | 15 | 21 | |
| Operator<br>2 | Negative | 18 | 13 | 11 | 1 | 0 | |
| | Positive | 0 | 0 | 0 | 16 | 21 | |
| Operator<br>3 | Negative | 18 | 13 | 10 | 0 | 0 | |
| | Positive | 0 | 0 | 1 | 17 | 21 | |
# Discordant Results of Cocaine Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 285 | Negative |
| 2 | 285 | Negative |
| 3 | 285 | Positive |
| 1 | 313 | Negative |
| 2 | 313 | Negative |
| 3 | 313 | Positive |
| 1 | 321 | Negative |
| 2 | 321 | Positive |
| 3 | 321 | Positive |
| Split<br>Key Cup | Results | Negative<br>Urine | <-50% cut off | -50% cut off- cut off | Cut off-<br>+50% cut off | >+50% cut off |
|------------------|----------|-------------------|---------------|-----------------------|--------------------------|---------------|
| Operator 1 | Negative | 18 | 13 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 21 |
| Operator 2 | Negative | 18 | 13 | 11 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 16 | 21 |
| Operator 3 | Negative | 18 | 13 | 10 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 17 | 21 |
{28}------------------------------------------------
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 285 | Negative |
| 2 | 285 | Negative |
| 3 | 285 | Positive |
| 1 | 313 | Negative |
| 2 | 313 | Negative |
| 3 | 313 | Positive |
| 1 | 321 | Negative |
| 2 | 321 | Positive |
| 3 | 321 | Positive |
# Discordant Results of Cocaine Split Key Cup
# Oxazepam
| Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut off-<br>+50% cut off | >+50% cut<br>off |
|---------------|----------|-------------------|------------------|--------------------------|--------------------------|------------------|
| Operator<br>1 | Negative | 15 | 10 | 15 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 19 | 20 |
| Operator<br>2 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
| Operator<br>3 | Negative | 15 | 10 | 14 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 20 | 20 |
# Discordant Results of Oxazepam Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 333 | Negative |
| 2 | 333 | Positive |
| 3 | 333 | Positive |
{29}------------------------------------------------
| 1 | 298 | Negative |
|---|-----|----------|
| 2 | 298 | Negative |
| 3 | 298 | Positive |
| Split<br>Key Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut off-<br>+50% cut off | >+50% cut<br>off |
|------------------|----------|-------------------|------------------|--------------------------|--------------------------|------------------|
| Operator<br>1 | Negative | 15 | 10 | 15 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 19 | 20 |
| Operator<br>2 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
| Operator<br>3 | Negative | 15 | 10 | 15 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 20 | 20 |
# Discordant Results of Oxazepam Split Key Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 333 | Negative |
| 2 | 333 | Positive |
| 3 | 333 | Positive |
# Methamphetamine
| Cup | Results | Negative<br>Urine | <-50%<br>off | -50% cut off-<br>cut off | Cut off-<br>+50% cut off | >+50%<br>off |
|---------------|----------|-------------------|--------------|--------------------------|--------------------------|--------------|
| Operator<br>1 | Negative | 17 | 16 | 8 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 11 | 29 |
| Operator<br>2 | Negative | 17 | 16 | 8 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 10 | 29 |
| Operator<br>3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
{30}------------------------------------------------
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 1025 | Positive |
| 2 | 1025 | Negative |
| 3 | 1025 | Positive |
| 1 | 984 | Negative |
| 2 | 984 | Negative |
| 3 | 984 | Positive |
| Split<br>Key Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut<br>+50% cut off | >+50% cut<br>off |
|------------------|----------|-------------------|------------------|--------------------------|---------------------|------------------|
| Operator<br>1 | Negative | 17 | 16 | 8 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 11 | 29 |
| Operator<br>2 | Negative | 17 | 16 | 8 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 10 | 29 |
| Operator<br>3 | Negative | 17 | 16 | 7 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 11 | 29 |
# Discordant Results of Methamphetamine Split Key Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 1025 | Positive |
| 2 | 1025 | Negative |
| 3 | 1025 | Positive |
| 1 | 984 | Negative |
| 2 | 984 | Negative |
| 3 | 984 | Positive |
# Morphine
{31}------------------------------------------------
| Cup | Results | Negative Urine | <-50% cut off | -50% cut off- cut off | Cut off-+50% cut off | >+50% cut off |
|------------|----------|----------------|---------------|-----------------------|----------------------|---------------|
| Operator 1 | Negative | 19 | 9 | 13 | 0 | 0 |
| | Positive | 0 | 0 | 0 | 15 | 25 |
| Operator 2 | Negative | 19 | 9 | 13 | 2 | 0 |
| | Positive | 0 | 0 | 0 | 13 | 25 |
| Operator 3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
# Discordant Results of Morphine Cup
| 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 |
| Split<br>Key Cup | Results | Negative<br>Urine | <-50% cut<br>off | -50% cut off-<br>cut off | Cut<br>+50% cut off | >+50% cut<br>off |
|------------------|----------|-------------------|------------------|--------------------------|---------------------|------------------|
| Operator<br>1 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
| Operator<br>2 | Negative | 19 | 9 | 13 | 1 | 0 |
| | Positive | 0 | 0 | 0 | 14 | 25 |
| Operator<br>3 | Negative | 19 | 9 | 12 | 0 | 0 |
| | Positive | 0 | 0 | 1 | 15 | 25 |
{32}------------------------------------------------
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 323 | Positive |
| 2 | 323 | Negative |
| 3 | 323 | Positive |
| 1 | 293 | Positive |
| 2 | 293 | Negative |
| 3 | 293 | Positive |
## Discordant Results of Morphine Split Key Cup
# Marijuana
| Cup | Results | Negative<br>Urine | <-50%<br>cut<br>off | cut | -50% cut off-<br>cut off | Cut<br>off-<br>+50% cut off | >+50%<br>cut<br>off |
|---------------|----------|-------------------|---------------------|-----|--------------------------|-----------------------------|---------------------|
| Operator<br>1 | Negative | 18 | 11 | 13 | 3 | 0 | |
| | Positive | 0 | 0 | 0 | 13 | 24 | |
| Operator<br>2 | Negative | 18 | 11 | 13 | 2 | 0 | |
| | Positive | 0 | 0 | 0 | 14 | 24 | |
| Operator<br>3 | Negative | 18 | 11 | 13 | 0 | 0 | |
| | Positive | 0 | 0 | 0 | 16 | 24 | |
## Discordant Results of Marijuana Cup
| Operator | GC/MS Result(ng/mL) | Candidate Device Result |
|----------|---------------------|-------------------------|
| 1 | 61 | Negative |
| 2 | 61 | Negative |
| 3 | 61 | Positive |
| 1 | 61 | Negative |
| 2 | 61 | Positive |
| 3 | 61 | Positive |
| 1 | 59 | Negative…
