Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is described as a rapid lateral flow immunoassay, which is a traditional diagnostic technology that does not typically incorporate AI/ML. There is no mention of AI, ML, or image processing in the summary.

Therapeutic

No
This device is for in vitro diagnostic use, specifically for the qualitative detection of drugs of abuse in human urine. It provides preliminary test results and does not offer any therapeutic benefit or treatment.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." for both the OTC and Rx versions of the device. The device performs qualitative detection of substances in human urine, which is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device is described as a "rapid lateral flow immunoassay" and an "immunochromatographic assay that use a lateral flow system," which are hardware-based diagnostic tests. The description focuses on the physical test cassette and its chemical reactions, not software functionality.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The intended use section for both the OTC and Rx versions clearly states: "For in vitro diagnostic use only."
Intended Use: The device is intended for the qualitative detection of specific substances (drugs of abuse) in a human biological specimen (urine). This is a core characteristic of an in vitro diagnostic device.
Device Description: The description details an "immunochromatographic assay that use a lateral flow system for the qualitative detection of... target analytes in human urine." This describes a common type of IVD test.
Performance Studies: The document describes various performance studies (Analytical Performance, Cut-off, Interference, Specificity, Effect of Urine Specific Gravity and Urine pH, Comparison Studies, Lay-user study) which are typical evaluations performed for IVD devices to demonstrate their analytical and clinical performance.
Predicate Device: The mention of predicate devices (K173303) which are also described as "Multi-Drug of Abuse Urine Test" further supports the classification of this device as an IVD. These predicate devices are already classified as IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

DJC, LDJ, DKZ, JXM, NFT, DIO, NFY, NFV, NGG, DNK, NGI, NFW

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-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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For in vitro diagnostic use only. The test is intended for over the counter use.
For in vitro diagnostic use only. The test is intended for prescription use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Performance (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. 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.

Analytical Performance (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.

Analytical Performance (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 tables.

Analytical Performance (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. There were no differences observed for different devices.

Analytical Performance (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.

Comparison Studies: Method comparison studies 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.

Lay-user study: A lay user study was performed at three intended user sites for the OTC and Rx use products separately. The lay users had diverse educational and professional backgrounds and ranged in age from 20 to > 50 years. Urine samples were prepared at specified concentrations (negative, +/-75%, +/-50%, +/-25% of the cutoff) by spiking drug(s) into drug-free-pooled urine specimens. The concentrations 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. Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

Key results from Lay-user study:

Amphetamine: -25% cut off (90% correct), +25% cut off (95% correct), All other cut-offs (100% correct).
Cocaine: -25% cut off (90% correct), All other cut-offs (100% correct).
Oxazepam: -25% cut off (95% correct), All other cut-offs (100% correct).
Methamphetamine: -25% cut off (90% correct), All other cut-offs (100% correct).
Morphine: -25% cut off (90% correct), All other cut-offs (100% correct).
Marijuana: All cut-offs (100% correct).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K173303

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.3610 Methamphetamine test system.

(a)
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.(b)
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).

Summary

0

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)

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)
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."

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.
Room 313, Building 2, No. 2715 Longwu Road,
Xuhui District, Shanghai, China. |
|-----------------|------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ethan Liu
Phone:0086-15216699240
Fax: 0086-21-60732022
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
Amphetamine Test System	Toxicology
JXM, NFV	21 CFR, 862.3170
Benzodiazepine Test
System	Toxicology
DIO, NFY	21 CFR, 862.3250 Cocaine
and cocaine metabolite test
system.	Toxicology
DJC, NGG	21 CFR, 862.3610
Methamphetamine Test
System	Toxicology
LDJ, NFW	21 CFR, 862.3870
Cannabinoid Test System	Toxicology
DNK, NGI	21 CFR, 862.3640
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
Use	For the qualitative determination of
drugs of abuse in human urine.	Same
Calibrator	d-Amphetamine	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	1000ng/mL	Same
Intended Use	For over-the-counter and prescription
uses.	Same
Configurations	Cassette	Cassette, Easy
Cup, Split Key
Cup and Dip
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
Device-K173303 |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indication(s) for
Use | For the qualitative determination of
drugs of abuse in human urine. | Same |
| Calibrator | Oxazepam | 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 |

10

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 4: Features comparison of Methamphetamine 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 | d-Methamphetamine | 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 | 1000ng/mL | Same |
| Intended Use | For over-the-counter and prescription
uses. | Same |
| Configurations | Cassette | Cassette, Easy
Cup, Split Key
Cup and Dip
Card |

Table 5: Features comparison of Morphine Tests and the Predicate Devices.

Item	Device	Predicate
------	--------	-----------

11

		Device-K173303
Indication(s) for
Use	For the qualitative determination of
drugs of abuse in human urine.	Same
Calibrator	Morphine	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	2000ng/mL
Intended Use	For over-the-counter and prescription
uses.	Same
Configurations	Cassette	Cassette, Easy
Cup, Split Key
Cup and Dip
Card

Table 6: Features comparison of Marijuana 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 | 11-Nor-Δ9-Tetrahydrocannabinol-9-COOH | 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 |

12

Cut-off Values	50ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette	Cassette, Easy
Cup, Split Key
Cup and Dip
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%	Cut off	25%
	100%
cut off	cut off	cut off	cut off	cut off	Cut
off	cut off	cut off
AMP2-
10010301	50-
/0+	50-
/0+	50-
/0+	50-
/0+	28-
/22+	50+/0

| 50+/0
| 50+/0
| 50+/0
|
| AMP2-
10010302 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 26-
/24+ | 50+/0
| 50+/0
| 50+/0
| 50+/0
|
| AMP2-
10010303 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 26-
/24+ | 50+/0
| 50+/0
| 50+/0
| 50+/0
|

COC Assay

Lot Number		-75%	-50%	Cut off	25%
	100%
cut off	cut off	cut off	cut off	cut off	Cut
off	cut off	cut off
COC2-
10110301	50-
/0+	50-
/0+	50-
/0+	50-
/0+	27-
/23+	50+/0

| 50+/0
| 50+/0
| 50+/0
|
| COC2-
10110302 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 24-
/26+ | 50+/0
| 50+/0
| 50+/0
| 50+/0
|

14

| COC2-
10110303 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 26-
/24+ | 50+/0 | 50+/0 | 50+/0 | 50+/0 |
|-------------------|------------|------------|------------|------------|-------------|-------|-------|-------|-------|
| | | | | | | - | - | - | - |

Oxazepam Assay

| Lot Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cut off | Cut off | 25%
cut off | 50%
Cut off | 75%
cut off | 100%
cut off |
|-------------------|------------------|-----------------|-----------------|-----------------|---------|----------------|----------------|----------------|-----------------|
| BZO2-
10111601 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| BZO2-
10111602 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| BZO2-
10111603 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

MET Assay

| Lot Number | - | -75%
cut off | -50%
cut off | -25%
cut off | Cut off | 25%
cut off | 50%
Cut off | 75%
cut off | 100%
cut off |
|-----------------|-----------------|-----------------|-----------------|-----------------|-------------|----------------|----------------|----------------|-----------------|
| | 100%
cut off | | | | | | | | |
| GA00040800
4 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 10-
/40+ | 50+/0

```
| 50+/0
```
```
| 50+/0
```
```
| 50+/0
```
```
 |
```

| GA00040800
5 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 9-/41+ | 50+/0

```
| 50+/0
```
```
| 50+/0
```
```
| 50+/0
```
```
 |
```

| GA00040800
6 | 50-
/0+ | 50-
/0+ | 50-
/0+ | 50-
/0+ | 10-
/40+ | 50+/0

```
| 50+/0
```
```
| 50+/0
```
```
| 50+/0
```
```
 |
```

15

MOP Assay

| Lot Number | -
100%
cut off | -75%
cut off | -50%
cut off | -25%
cut off | Cut off | 25%
cut off | 50%
Cut
off | 75%
cut off | 100%
cut off |
|-----------------|----------------------|-----------------|-----------------|-----------------|-------------|----------------|-------------------|----------------|-----------------|
| GA00020800
1 | 50-/
0+ | 50-/
0+ | 50-/
0+ | 50-/
0+ | 17-/
33+ | 50+/0

```
| 50+/0
```
```
   | 50+/0
```
```
| 50+/0
```
```
 |
```

| GA00020800
2 | 50-/
0+ | 50-/
0+ | 50-/
0+ | 50-/
0+ | 19-/
31+ | 50+/0

```
| 50+/0
```
```
   | 50+/0
```
```
| 50+/0
```
```
 |
```

| GA00020800
3 | 50-/
0+ | 50-/
0+ | 50-/
0+ | 50-/
0+ | 15-/
35+ | 50+/0

```
| 50+/0
```
```
   | 50+/0
```
```
| 50+/0
```
```
 |
```

THC Assay

| Lot Number | -
100%
cut
off | -75%
cut
off | -50%
cut
off | -25%
cut
off | Cut off | 25%
cut
off | 50%
Cut
off | 75%
cut
off | 100%
cut
off |
|-------------------|-------------------------|--------------------|--------------------|--------------------|-------------|-------------------|-------------------|-------------------|--------------------|
| THC2-
10110901 | 50-/
0+ | 50-/
0+ | 50-/
0+ | 50-/
0+ | 36-/
14+ | 50+/0

```
   | 50+/0
```
```
   | 50+/0
```
```
   | 50+/0
```
```
    |
```

| THC2-
10110902 | 50-/
0+ | 50-/
0+ | 50-/
0+ | 50-/
0+ | 38-/
12+ | 50+/0

```
   | 50+/0
```
```
   | 50+/0
```
```
   | 50+/0
```
```
    |
```

| THC2-
10110903 | 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 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
Maleate
Promethazine	Amoxicillin	Methoxyphenamine	Ketamine
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
acetate	Cholesterol	Hydrocortisone	Oxycodone
Ethanol

Oxazepam Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	Chlorpheniramine
Maleate	Promethazine	Amoxicillin
Methoxyphenamine	Ketamine
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
acetate	Cholesterol	Amphetamine	Ethanol

COC Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine

18

| Amitriptyline | Chlorpheniramine
Maleate | Promethazine | Amoxicillin |
|------------------|-----------------------------|----------------|-------------------------|
| Methoxyphenamine | Ketamine
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
acetate |
| Cholesterol | MDMA | Amphetamine | Ethanol |

MET Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	Chlorpheniramine
Maleate	Promethazine	Amoxicillin
Methoxyphenamine	Ketamine
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
Maleate	Promethazine	Amoxicillin
Methoxyphenamine	Ketamine
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
acetate	Amphetamine	MDMA	Ethanol

THC Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	Chlorpheniramine
Maleate	Promethazine	Amoxicillin
Methoxyphenamine	Ketamine
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
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	100,000
----------	----------	-----------
----------	----------	-----------

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
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 |
|------------|----------|----------|---------------|----------------------|---------------------|---------------|
| 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
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
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 |
|------------|----------|----------|---------------|----------------------|---------------------|---------------|
| 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
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
samples | Cocaine
Concentration
by
GC/MS(ng/m
L) | Number of
Positive | Number of
Negative | Percentage of
Correct
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
samples | Oxazepam
Concentration
by
GC/MS(ng/m
L) | Number of
Positive | Number of
Negative | Percentage of
Correct
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% |

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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
samples | Morphine
Concentration
by
GC/MS(ng/m
L) | Number of
Positive | Number of
Negative | Percentage of
Correct
Results(%) |
|---------------|----------------------|-----------------------------------------------------|-----------------------|-----------------------|----------------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 70 | 0 | 20 | 100% |
| -50% cut off | 20 | 136 | 0 | 20 | 100% |
| -25% cut off | 20 | 228 | 2 | 18 | 90% |
| +25% cut off | 20 | 378 | 20 | 0 | 100% |
| +50% cut off | 20 | 445 | 20 | 0 | 100% |
| +75% cut off | 20 | 510 | 20 | 0 | 100% |

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| % of cut off | Number of
samples | Marijuana
Concentration
by
GC/MS(ng/m
L) | Number of
Positive | Number of
Negative | Percentage of
Correct
Results(%) |
|---------------|----------------------|------------------------------------------------------|-----------------------|-----------------------|----------------------------------------|
| -100% cut off | 20 | 0 | 0 | 20 | 100% |
| -75% cut off | 20 | 10 | 0 | 20 | 100% |
| -50% cut off | 20 | 24 | 0 | 20 | 100% |
| -25% cut off | 20 | 36 | 0 | 20 | 100% |
| +25% cut off | 20 | 60 | 20 | 0 | 100% |
| +50% cut off | 20 | 73 | 20 | 0 | 100% |
| +75% cut off | 20 | 82 | 20 | 0 | 100% |

Comparison between GC/MS and Lay Person Results for Marijuana Cassette

Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.

5.9 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, SHANGHAI VENTURE BIO-TECH CO., LTD has demonstrated that proposed device 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 substantially equivalent to predicate.

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