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 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.

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

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

AI/ML Overview

The document describes the performance of the BIO-VENTURE Rapid Amphetamine Test Cassette and similar rapid test cassettes for other drugs (Oxazepam, Cocaine, Methamphetamine, Morphine, Marijuana). These are qualitative lateral flow immunoassays designed for both OTC and Rx use.

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these devices are implicitly defined by their ability to accurately distinguish between drug concentrations above and below specified cut-off levels. The primary performance metrics presented are precision, cut-off verification, interference, specificity, and comparison with GC/MS results. For the lay-user study, the acceptance criteria are a high percentage of correct results near the cut-off concentrations and ease of use/understanding for lay users.

Table of Acceptance Criteria and Reported Device Performance

Performance Study	Measured Metric / Acceptance Criterion	Reported Performance
Precision	Consistent results at specific drug concentrations relative to the cut-off (e.g., all negative below -25% cut-off, all positive above +25% cut-off).	For all assays (AMP, COC, BZO, MET, MOP, THC): -100% to -25% cut-off: 100% negative results across three lots, 6 operators, 25 days (e.g., 50-/0+ for 150 samples per drug per lot category). +25% to +100% cut-off: 100% positive results across three lots, 6 operators, 25 days (e.g., 50+/0- for 150 samples per drug per lot category). At cut-off: Mixed results as expected (e.g., for AMP, 28-/22+, 26-/24+ across the three lots, indicating some negative/positive calls around the cut-off).
Cut-off Verification	All results positive at and above +25% Cut-off; all results negative at and below -25% Cut-off.	Achieved for Amphetamine, Cocaine, Oxazepam, Methamphetamine, Morphine, and Marijuana. Verified against the specified cutoff values.
Interference	No interference from common substances at 100 µg/mL (and Ethanol at 1%).	No interference observed from a comprehensive list of tested compounds for all assays.
Specificity	Cross-reactivity % and lowest concentration causing a positive result for related substances.	Detailed tables provided for each drug, showing specificity to the target analyte and cross-reactivity with structurally similar compounds. For example, d-Amphetamine showed 100% cross-reactivity at 1000 ng/mL, while d/L-Amphetamine showed 66.7% at 1500 ng/mL.
Effect of Urine Specific Gravity & pH	Consistent results across a range of specific gravity (1.002-1.036) and pH (4-9).	Achieved for all assays; results were 100% positive at and above +25% Cut-off and 100% negative at and below -25% Cut-Off.
Method Comparison (Clinical Samples)	High concordance with GC/MS results, especially distant from cut-off. Discordant results primarily near the cut-off.	For all drugs, samples well below the cut-off (negative, <-50% cut-off) were consistently negative by the cassette, and samples well above the cut-off (>+50% cut-off) were consistently positive. Discordant results were observed predominantly in samples close to the +/- cut-off value range as expected for rapid qualitative assays, indicating the device's sensitivity is around the stated cut-off. For example, for Amphetamine, 3 operators, 87 samples: Operator 1: 1 Negative at 989 ng/mL (just below 1000 ng/mL cut-off), 1 Negative at 1035 ng/mL (just above cut-off), 1 Negative at 1062 ng/mL. Operator 2: 1 Positive at 989 ng/mL, 1 Negative at 1035 ng/mL, 1 Positive at 1062 ng/mL.
Lay-User Study	High percentage of correct results, especially for clearly negative/positive samples. Ease of understanding instructions.	For all drugs (AMP, Cocaine, Oxazepam, Methamphetamine, Morphine, Marijuana): -100% to -50% cut-off: 100% correct negative results. +25% to +75% cut-off: 95% to 100% correct positive results. At -25% cut-off: 90-95% correct negative results. All lay users indicated instructions were easy to follow (Flesch-Kincaid Grade Level 7).

Study Details:

Sample sizes used for the test set and the data provenance:
- Precision Study: For each drug assay (AMP, COC, Oxazepam, MET, MOP, THC), there were 6 drug concentrations tested (from -100% to +100% cut-off, skipping -75%, +75%, and -50%, but then showing -75% and +75% in the table). Each concentration likely involved multiple replicates over 25 days across 3 lots and 6 operators.
  - The tables show results for 6 concentrations per lot, with 50 results per concentration (e.g., 50-/0+ means 50 negative, 0 positive). With 3 lots and 6 operators, performing 9 samples for 25 days per device, this is a very large number of total tests, difficult to sum precisely from the given table format for all concentrations. However, for a given concentration and lot, it appears 50 tests were performed (e.g., 50-/0+).
- Cut-off Verification: 125 samples tested per drug (equally distributed at -50%, -25%, Cut-Off, +25%, +50% cut-off). Tested using three different lots of each device by three different operators.
- Interference & Effect of Specific Gravity/pH: Not explicitly stated, but implies a similar number of samples at 25% below and 25% above cut-off for each interference/pH/SG factor.
- Comparison Studies (Clinical Samples):
  - Amphetamine: 87 samples
  - Cocaine: 80 samples
  - Oxazepam: 80 samples
  - Methamphetamine: 81 samples
  - Morphine: 81 samples
  - Marijuana: 82 samples
- Lay-User Study: For each drug, 20 samples were tested at each of 7 concentration levels (total 140 samples per drug type).
- Data Provenance: Not explicitly stated regarding country of origin for the clinical samples. The precision samples were prepared by spiking drug in negative samples. The clinical samples were "unaltered clinical samples." The studies were performed "in-house" and at "three intended user sites" (for the lay-user study). The document refers to Shanghai Venture Bio-Tech CO., Ltd. in China, suggesting an origin in China for the test execution, though clinical samples might be from other regions. The studies are prospective in nature, as they involve testing samples under controlled conditions to evaluate device performance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the Precision Study, ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry), which is considered the preferred confirmatory method for drug testing, thus a highly accurate and objective ground truth method. The document states: "Each drug concentration was confirmed by GC/MS."
- For the Method Comparison Studies (Clinical Samples), the ground truth was also established by GC/MS results. The samples were "compared to GC/MS results."
- For the Lay-User Study, the concentrations of the samples were also confirmed by GC/MS.
- The document does not explicitly state the number or qualifications of experts (e.g., radiologists) involved in establishing ground truth, as the ground truth here is analytical (GC/MS) rather than expert consensus on medical images.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No adjudication method (like 2+1 or 3+1 expert consensus) is mentioned. The ground truth for all performance studies (precision, method comparison, lay-user study) was based on GC/MS, which is an objective chemical method and generally does not require human adjudication in the same way image interpretation might. For the clinical sample comparison, the device results were simply compared against the GC/MS result.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This is not applicable to the described device. The device is a rapid diagnostic test (lateral flow immunoassay) for detecting drugs in urine, not an AI-assisted diagnostic tool for human readers interpreting medical images. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is generally applicable because the device itself is a standalone test that produces a visible result (lines on a cassette). Its performance is evaluated independently.
- The "Comparison Studies" with clinical samples and the "Precision Studies" are forms of standalone performance evaluation for the device when operated by trained laboratory personnel.
- The "Lay-user study" also assesses the device's standalone performance, but crucially, it evaluates how well untrained individuals can interpret the device's results.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The primary ground truth used for all performance evaluations (precision, clinical comparison, lay-user study samples) was Gas Chromatography/Mass Spectrometry (GC/MS) results. This is considered the laboratory gold standard for confirming drug presence and concentration.
The sample size for the training set:
- The document describes a medical device (rapid immunoassay cassette), not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of AI/ML model development. The device's "training" corresponds to its chemical and physical design and manufacturing process.
How the ground truth for the training set was established:
- Not applicable, as there is no AI/ML training set. The ground truth for the testing of these devices was established using GC/MS.

Summary

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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 17, 2018

Shanghai Venture Bio-Tech CO., Ltd. % Ethan Liu, RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Floor 6, No.211, Xin Ling Road, Minhang District Shanghai. 201100 China

Re: K180878

Trade/Device Name: BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use BIO-VENTURE Rapid Morphine Test Cassette for OTC Use BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use BIO-VENTURE Rapid Morphine Test Cassette for Rx Use BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use Regulation Number: 21 CFR 862.3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Code: DJC, LDJ, DKZ, JXM, NFT, DIO, NFY, NFV, NGG, DNK, NGI, NFW Dated: October 30, 2018 Received: November 5, 2018

Dear Ethan Liu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration,

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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

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Indications for Use

510(k) Number (if known) K180878

Device Name

Indications for Use (Describe)

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.

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."

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Indications for Use

in human urine. The test cut-off

510(k) Number (if known) K180878

Device Name

Indications for Use (Describe)

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.

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.

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."

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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 LiuPhone:0086-15216699240Fax: 0086-21-60732022Email:xtdeepwater@126.com
Date Prepared:	Dec 15, 2018

5.2 Device

5.2.1 Trade Name

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Marijuana Test Cassette for Rx Use

5.2.2 Classification:

Product Code	CFR #	Panel
DKZ, NFT	21 CFR, 862.3100Amphetamine Test System	Toxicology
JXM, NFV	21 CFR, 862.3170Benzodiazepine TestSystem	Toxicology
DIO, NFY	21 CFR, 862.3250 Cocaineand cocaine metabolite testsystem.	Toxicology
DJC, NGG	21 CFR, 862.3610Methamphetamine TestSystem	Toxicology
LDJ, NFW	21 CFR, 862.3870Cannabinoid Test System	Toxicology
DNK, NGI	21 CFR, 862.3640Morphine 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

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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.

Clinical consideration and professional judgment should be exercised with any drug of

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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.

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.

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

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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) forUse	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator	d-Amphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-off Values	1000ng/mL	Same
Intended Use	For over-the-counter and prescriptionuses.	Same
Configurations	Cassette	Cassette, EasyCup, Split KeyCup and DipCard

	Table 1: Features comparison of Amphetamine Tests and the Predicate Devices.

Table 2: Features comparison of Cocaine Tests and the Predicate Devices.

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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	PredicateDevice-K173303
Indication(s) forUse	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator	Oxazepam	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same

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Cut-off Values	300ng/mL	Same
Intended Use	For over-the-counter and prescriptionuses.	Same
Configurations	Cassette	Cassette, EasyCup, Split KeyCup and DipCard

Table 4: Features comparison of Methamphetamine Tests and the Predicate Devices.

Item	Device	PredicateDevice-K173303
Indication(s) forUse	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator	d-Methamphetamine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-off Values	1000ng/mL	Same
Intended Use	For over-the-counter and prescriptionuses.	Same
Configurations	Cassette	Cassette, EasyCup, Split KeyCup and DipCard

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

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

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		Device-K173303
Indication(s) forUse	For the qualitative determination ofdrugs of abuse in human urine.	Same
Calibrator	Morphine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays basedon the principle of antigen antibodyimmunochemistry.	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 prescriptionuses.	Same
Configurations	Cassette	Cassette, EasyCup, Split KeyCup and DipCard

Table 6: Features comparison of Marijuana Tests and the Predicate Devices.

Item	Device	PredicateDevice-K173303
Indication(s)for Use	For the qualitative determination of drugsof abuse in human urine.	Same
Calibrator	11-Nor-Δ9-Tetrahydrocannabinol-9-COOH	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
SpecimenType	Human Urine	Same

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Cut-off Values	50ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette	Cassette, EasyCup, Split KeyCup and DipCard

5.7 Test Principle

The BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use are rapid tests for the qualitative detection of d-Amphetamine, Oxazepam, Benzoylecgonine, d-Methamphetamine, Morphine and Delta-9-THC-COOH in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff concentration because it will saturate all the binding sites of the antibody coated on the particles.

A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been performed properly.

5.8 Performance Characteristics

5.8.1 Analytical Performance

a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off and +100% cut off, These

{13}------------------------------------------------

samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by GC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. Each concentration has three lots, and 6 operators have joined the performance. Each operator performs 9 samples for 25days per device in a randomized order. The results obtained are summarized in the following tables.

AMP Assay

Lot Number	-	-75%	-50%	-25%	Cut off	25%	50%	75%	100%
	100%cut off	cut off	cut off	cut off		cut off	Cutoff	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%	-25%	Cut off	25%	50%	75%	100%
	100%cut off	cut off	cut off	cut off		cut off	Cutoff	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
GA000408004	50-/0+	50-/0+	50-/0+	50-/0+	10-/40+	50+/0-	50+/0-	50+/0-	50+/0-
GA000408005	50-/0+	50-/0+	50-/0+	50-/0+	9-/41+	50+/0-	50+/0-	50+/0-	50+/0-
GA000408006	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%Cutoff	75%cut off	100%cut off
GA000208001	50-/0+	50-/0+	50-/0+	50-/0+	17-/33+	50+/0-	50+/0-	50+/0-	50+/0-
GA000208002	50-/0+	50-/0+	50-/0+	50-/0+	19-/31+	50+/0-	50+/0-	50+/0-	50+/0-
GA000208003	50-/0+	50-/0+	50-/0+	50-/0+	15-/35+	50+/0-	50+/0-	50+/0-	50+/0-

THC Assay

Lot Number	-100%cutoff	-75%cutoff	-50%cutoff	-25%cutoff	Cut off	25%cutoff	50%Cutoff	75%cutoff	100%cutoff
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	ChlorpheniramineMaleate
Promethazine	Amoxicillin	Methoxyphenamine	KetamineHydrochloride
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
Prednisoloneacetate	Cholesterol	Hydrocortisone	Oxycodone
Ethanol

Oxazepam Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	ChlorpheniramineMaleate	Promethazine	Amoxicillin
Methoxyphenamine	KetamineHydrochloride	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
Prednisoloneacetate	Cholesterol	Amphetamine	Ethanol

COC Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine

{18}------------------------------------------------

Amitriptyline	ChlorpheniramineMaleate	Promethazine	Amoxicillin
Methoxyphenamine	KetamineHydrochloride	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	Prednisoloneacetate
Cholesterol	MDMA	Amphetamine	Ethanol

MET Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	ChlorpheniramineMaleate	Promethazine	Amoxicillin
Methoxyphenamine	KetamineHydrochloride	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	ChlorpheniramineMaleate	Promethazine	Amoxicillin
Methoxyphenamine	KetamineHydrochloride	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
Prednisoloneacetate	Amphetamine	MDMA	Ethanol

THC Assay

Methadone	Naltrexone	Naloxone	Morphine
Ephedrine	Pseudo Ephedrine	Gatifloxacin	Procaine
Amitriptyline	ChlorpheniramineMaleate	Promethazine	Amoxicillin
Methoxyphenamine	KetamineHydrochloride	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
Prednisoloneacetate	Cholesterol	Hydrocortisone	Oxycodone
Ethanol

f. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below. There were no differences observed for different devices.

AMP Assay:

Drugs	Concentration(ng/mL)	%Cross Reactivity
D-Amphetamine	1000	100%
D/L- Amphetamine	1500	66.7%
Phentermine	3000	33.3%
L-Amphetamine	3000	33.3%
Hydroxyamphetamine	10000	10%
Methylenedioxyamphetamine(MDA)	10000	10%
3,4-methylenedioxy-methamphetamine(MDMA)	>100,000	<1%
Methylenedioxyethylamphetamine(MDE)	>100,000	<1%
Ephedrine	>100,000	<1%
Pseudophedrine	>100,000	<1%
D-Methamphetamine	>100,000	<1%

{21}------------------------------------------------

D/L-Methamphetamine	>100,000	<1%
---------------------	----------	-----

COC Assay

Drugs	Concentration(ng/mL)	%Cross Reactivity
Cocaine HCl	5000	6%
Norcocaine	25000	1.2%
Ecgonine HCl	50000	0.6%
Cocaethylene	>100000	<0.3%
Benzoylecgonine	300	100%

Oxazepam Assay

Drugs	Concentration(ng/mL)	%Cross Reactivity
Oxazepam	300	100%
Diazepam	1000	30%
Alprazolam	1000	30%
α-Hydroxyalprazolam	5000	6%
Bromazepam	10000	3%
Chlordiazepoxide	10000	3%
Clobazam	500	60%
Clonazepam	3000	10%
Delorazepam	5000	6%
Estazolam	10000	3%
Flunitrazepam	5000	6%
Midazolam	50000	0.6%
Nitrazepam	500	60%
Nordiazepam	5000	6%

{22}------------------------------------------------

Temazepam	500	60%
Triazolam	10000	3%
Lorazepam	25000	1.2%
Clorazepate Dipotassium	> 100000	<0.3%
Desalkylflurazepam	> 100000	<0.3%
Norchlordiazepoxide	> 100000	<0.3%

MET Assay

Drugs	Concentration(ng/mL)	% CrossReactivity
(±)3,4-methylenedioxy-n-ethylamphetamine(MDEA)	5000	20%
D-Methamphetamine	1000	100%
L-Methamphetamine	10000	10%
D/L- Methamphetamine	3000	33.3%
p-Hydroxymethamphetamine	50000	2%
(±)3,4-Methylenedioxyamphetamine(MDA)	20000	5%
(±)3,4-Methylenedioxymethamphetamine(MDMA)	3000	33.3%
D/L-Amphetamine	>100,000	<1%
D- Amphetamine	>100,000	<1%
L-Amphetamine	>100,000	<1%

MOP Assay

{23}------------------------------------------------

Drugs	Concentration	% CrossReactivity
Acetylmorphine	6000	5%
Hydromorphone	3000	10%
Hydrocodone	50000	0.6%
Levorphanol	1500	20%
Oxycodone	50000	0.6%
Dimethylmorphine	3000	10%
Morphine-3- Glucuronide	>100,000	<0.3%
Morphine	300	100%
Codeine	300	100%
Heroin	300	100%
O6- Monoacetylmorphine	300	100%
Ethylmorphine	>100000	<0.3%

THC Assay

Drugs	Concentration	% CrossReactivity
(-)-11-Nor-Δ9-Tetrahydrocannabinol-9-COOH	50	100%
11-Hydroxy-Δ9-Tetrahydrocannabinol	10000	0.5%
11- Nor-△8-Tetrahydrocannabinol-9-COOH	2500	2%
Cannabinol	5000	1%

{24}------------------------------------------------

11-Nor-∆9-THC-carboxy glucuronide	5000	1%
(-)-11-nor-9-carboxy-∆9-THC	10000	0.5%
∆8- Tetrahydrocannabinol	>50000	<0.1%
∆9- Tetrahydrocannabinol	>50000	<0.1%
Cannabidiol	>50000	<0.1%

g. Effect of Urine Specific Gravity and Urine pH

To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.002 to 1.036 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cutoff and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.

5.8.2. Comparison Studies

Method comparison studies for the BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Morphine Test Cassette for Rx Use, BIO-VENTURE Rapid Marijuana Test Cassette for Rx Use were performed in-house with three laboratory assistants for each device. Operators ran unaltered clinical samples, 87 samples for amphetamine, 80 samples for cocaine, 80 samples for Oxazepam, 81 samples for Methamphetamine, 81 samples for Morphine, 82 samples for Marijuana. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables below:

Amphetamine

Cassette	Negative	<-50% cut	-50% cut	Cutoff~+50%cut	>+50% cut
----------	----------	-----------	----------	--------------------	-----------

{25}------------------------------------------------

			off	off~cut off	off	off
Operator 1	Negative	19	16	11	1	0
	Positive	0	0	0	13	27
Operator 2	Negative	19	16	10	1	0
	Positive	0	0	1	13	27
Operator 3	Negative	19	16	10	0	0
	Positive	0	0	1	14	27

Discordant Results of Amphetamine Cassette

Operator	GC/MS Result(ng/mL)	Candidate Device Result
1	989	Negative
2	989	Positive
3	989	Positive
1	1035	Positive
2	1035	Negative
3	1035	Positive
1	1062	Negative
2	1062	Positive
3	1062	Positive

Cocaine

Cassette		Negative	<-50% cutoff	-50% cutoff~cut off	Cutoff~+50%cutoff	>+50% cutoff
Operator 1	Negative	18	13	11	0	0
	Positive	0	0	0	17	21
Operator 2	Negative	18	13	9	0	0
	Positive	0	0	2	17	21

{26}------------------------------------------------

Operator 3	Negative	18	13	9	0	0
	Positive	0	0	2	17	21

Discordant Results of Cocaine Cassette

Operator	GC/MS Result(ng/mL)	Candidate Device Result
1	278	Negative
2	278	Positive
3	278	Positive
1	285	Negative
2	285	Positive
3	285	Positive

Oxazepam

Cassette		Negative	<-50% cut off	-50% cut off~cut off	Cut off~+50%cut off	>+50% cut off
Operator 1	Negative	15	10	15	0	0
	Positive	0	0	0	20	20
Operator 2	Negative	15	10	13	0	0
	Positive	0	0	2	20	20
Operator 3	Negative	15	10	13	0	0
	Positive	0	0	2	20	20

Discordant Results of Oxazepam Cassette

Operator	GC/MS Result(ng/mL)	Candidate Device Result
1	283	Negative
2	283	Positive
3	283	Negative

{27}------------------------------------------------

1	288	Negative
2	288	Positive
3	288	Positive
1	298	Negative
2	298	Negative
3	298	Positive

Methamphetamine

Cassette		Negative	<-50% cutoff	-50% cutoff~cut off	Cutoff~+50%cutoff	>+50% cutoff
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% cutoff	-50% cutoff~cut off	Cutoff~+50%cutoff	>+50% cutoff
Operator 1	Negative	19	9	12	0	0
	Positive	0	0	1	15	25
Operator 2	Negative	19	9	13	3	0
	Positive	0	0	0	12	25
Operator 3	Negative	19	9	12	0	0
	Positive	0	0	1	15	25

Discordant Results of Morphine Cassette

Operator	GC/MS Result(ng/mL)	Candidate Device Result
1	323	Positive
2	323	Negative
3	323	Positive
1	335	Positive
2	335	Negative
3	335	Positive
1	293	Positive
2	293	Negative
3	293	Positive

{29}------------------------------------------------

1	325	Positive
2	325	Negative
3	325	Positive

Marijuana

Cassette		Negative	<-50% cut off	-50% cut off~cut off	Cut off~+50%cut off	>+50% cut off
Operator 1	Negative	18	11	13	4	0
	Positive	0	0	0	12	24
Operator 2	Negative	18	11	13	0	0
	Positive	0	0	0	16	24
Operator 3	Negative	18	11	13	1	0
	Positive	0	0	0	15	24

Discordant Results of Marijuana Cassette

Operator	GC/MS Result(ng/mL)	Candidate Device Result
1	61	Negative
2	61	Positive
3	61	Positive
1	59	Negative
2	59	Positive
3	59	Negative
1	61	Negative
2	61	Positive
3	61	Positive
1	59	Negative
2	59	Positive

{30}------------------------------------------------

	CO2	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 ofsamples	CocaineConcentrationbyGC/MS(ng/mL)	Number ofPositive	Number ofNegative	Percentage ofCorrectResults(%)
-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 ofsamples	OxazepamConcentrationbyGC/MS(ng/mL)	Number ofPositive	Number ofNegative	Percentage ofCorrectResults(%)
-100% cut off	20	0	0	20	100%
-75% cut off	20	64	0	20	100%
-50% cut off	20	141	0	20	100%
-25% cut off	20	221	1	19	95%
+25% cut off	20	362	20	0	100%
+50% cut off	20	440	20	0	100%
+75% cut off	20	530	20	0	100%

{32}------------------------------------------------

% 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 ofsamples	MorphineConcentrationbyGC/MS(ng/mL)	Number ofPositive	Number ofNegative	Percentage ofCorrectResults(%)
-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 ofsamples	MarijuanaConcentrationbyGC/MS(ng/mL)	Number ofPositive	Number ofNegative	Percentage ofCorrectResults(%)
-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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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).