Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, with no mention of AI or ML. The analysis is based on visual interpretation of lines on the test strip.

Therapeutic

No
The device is an in vitro diagnostic device used for the qualitative detection of drugs in human urine. It provides preliminary test results and is not intended for treatment or prevention of disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states: "BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations..." This indicates the device is used to detect substances, which is a diagnostic function. Furthermore, the "Device Description" states "The products are single-use in vitro diagnostic devices," explicitly confirming its diagnostic nature.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an immunochromatographic assay using a lateral flow system and includes a physical test device and urine cup, indicating it is a hardware-based in vitro diagnostic device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided text, the device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
Device Description: The "Device Description" section describes the products as "single-use in vitro diagnostic devices."
Nature of the Test: The test is designed to detect specific substances (drugs) in a biological sample (human urine) outside of the body, which is the definition of an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

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

NGL, NGI, NFW, NFY, NGG, NFT, NFV, PTH, NGM, PTG, QAW, QBF

Device Description

The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

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 over-the-counter 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

Method comparison studies for the BIOEASY Multi-Drug Test Cup tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530.

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

Analytical Performance
a. Precision: Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530.
c. Stability: The devices are stable at 4-30 ℃ for 24 months based on the real time stability studies at both 4 ℃ and 30 ℃.
d. Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of the device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL, ethanol at 1%) were summarized.
e. Specificity: To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed for Morphine 2000 ng/mL cut-off. The data for Amphetamine, Oxazepam, Cocaine, Marijuana. Methamphetamine. Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530.
f. Effect of Urine Specific Gravity and Urine pH: Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed for different devices.
Comparison Studies: Method comparison studies for the BIOEASY Multi-Drug Test Cup tests were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530.
Lay-user study: A lay user study was performed at three intended user sites with 300 lay persons for the device. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/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. Summary results are shown for AMP, BAR, COC, BUP, MET, MTD, Morphine, OXY, PCP, THC, BZO, MDMA, TCA, and PPX. 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 Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Key metrics in the lay-user study for each drug are presented as percentage of correct results:
AMP: 100% correct for -100%, -75%, -50%, +25%, +50%, +75% Cutoff, and 95% correct for -25% Cutoff.
BAR: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
COC: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
BUP: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, 95% correct for -25% Cutoff, and 90% correct for +25% Cutoff.
MET: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
MTD: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
Morphine: 100% correct for -100%, -75%, -50%, -25% Cutoff and +50%, +75% Cutoff, and 95% correct for +25% Cutoff.
OXY: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
PCP: 100% correct for -100%, -75%, -50%, +25%, +50%, +75% Cutoff, and 95% correct for -25% Cutoff.
THC: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, 90% correct for -25% Cutoff, and 95% correct for +25% Cutoff.
BZO: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
MDMA: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
TCA: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.
PPX: 100% correct for -100%, -75%, -50% Cutoff and +50%, +75% Cutoff, and 95% correct for -25%, +25% Cutoff.

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.

K182530

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

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 31, 2020

Shenzhen Bioeasy Biotechnology Co., Ltd. % Joe Shia Director LSI 504E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K193480

Trade/Device Name: BIOEASY Multi-Drug Test Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL, NGI, NFW, NFY, NGG, NFT, NFV, PTH, NGM, PTG, QAW, QBF Dated: December 11, 2019 Received: December 16, 2019

Dear Joe Shia:

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

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

1

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Marianela Perez-Torres, M.T., Ph.D. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193480

Device Name BIOEASY Multi-Drug Test Cup

Indications for Use (Describe)

BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug(Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K193480 510(k) SUMMARY

January 27, 2020 1. Date: Shenzhen Bioeasy Biotechnology Co., Ltd. 2. Submitter: No.2-1, Liuxian 1st Road Baoan District Shenzhen, China 518101
Joe Shia 3. Contact person: LSI International Inc. 504 East Diamond Ave. Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
1. Device Name: BIOEASY Multi-Drug Test Cup

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFT
Amphetamine	II	21 CFR § 862.3100, Amphetamine
Test System	Toxicology (91)
NFW
Cannabinoids	II	21 CFR § 862.3870, Cannabinoids
Test System	Toxicology (91)
NFY
Cocaine	II	21 CFR § 862.3250, Cocaine and
Cocaine Metabolites Test System	Toxicology (91)
NGG
Methamphetamine	II	21 CFR § 862.3610,
Methamphetamine Test System	Toxicology (91)
NGI
Morphine	II	21 CFR § 862.3640, Morphine
Test System	Toxicology (91)
NFV
Oxazepam	II	21 CFR § 862.3170,
Benzodiazepine Test System	Toxicology (91)
NGL
Oxycodone	II	21 CFR § 862.3650, Opiate Test
System	Toxicology (91)
PTH
Secobarbital	II	21 CFR § 862.3150, Barbiturate
Test System	Toxicology (91)
NGL
Buprenorphine	II	21 CFR § 862.3650,
Opiate Test System	Toxicology (91)
NGG
Methylenedioxy-
methamphetamine	II	21 CFR § 862.3610,
Methamphetamine Test System	Toxicology (91)
NGM
Phencyclidine	unclassified	Enzyme Immunoassay
Phencyclidine	Toxicology (91)
PTG
Methadone	II	21 CFR § 862.3620, Methadone
Test System	Toxicology (91)
QAW
Nortriptyline	II	21 CFR, 862.3910 Tricyclic
Antidepressant Drugs Test System	Toxicology (91)
QBF
Propoxyphene	II	21 CFR, 862.3700 Propoxyphene
Test System	Toxicology (91)

1. Predicate Devices: K182530

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The Shenzhen Bioeasy Biotechnology's BIOEASY Multi-Drug Test Cup

1. Indications for Use
  BIOEASY Multi-Drug Test Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and d-Propoxyphene in human urine at the cutoff concentrations of:

Drug (Identifier)	Cut-off level
Amphetamine	1000 ng/mL
Oxazepam	300 ng/mL
Cocaine	300 ng/mL
Marijuana	50 ng/mL
Methamphetamine	1000 ng/mL
Morphine	300 ng/mL or 2000 ng/mL
Oxycodone	100 ng/mL
Secobarbital	300 ng/mL
Buprenorphine	10 ng/mL
Methylenedioxy-methamphetamine	500 ng/mL
Phencyclidine	25 ng/mL
Methadone	300 ng/mL
Nortriptyline	1000 ng/mL
d-Propoxyphene	300 ng/mL

Configuration of the BIOEASY Multi-Drug Test Cup tests can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

1. Device Description
  The BIOEASY Multi-Drug Test Cup tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. Each test kit contains a Test Device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch
1. Substantial Equivalence Information
  A summary comparison of features of the BIOEASY Multi-Drug Test Cup tests and the predicate devices is provided in following table.

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Table 1: Features Comparison of BIOEASY Multi-Drug Test Cup tests and the Predicate Devices

Item	Device	Predicate - K182530
Indication(s)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same
Calibrator and Cut-Off
Values	Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine(COC): 300 ng/ml
Marijuana (THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOP): 300ng/ml or 2000ng/mL
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
Methylenedioxy-
methamphetamine(MDMA): 500 ng/ml
Phencyclidine (PCP): 25 ng/ml
Methadone (MTD): 300 ng/ml
Nortriptyline (TCA): 1000 ng/ml
Propoxyphene (PPX): 300 ng/ml	Same except for
morphine 2000 ng/mL
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	Same

9. Test Principle

The BIOEASY Multi-Drug Test Cup tests are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibodycoated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been

7

performed properly.

10. Performance Characteristics

1. Analytical Performance
- a. Precision

Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the following table for Morphine 2000 ng/mL. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530.

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	29-/21+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-

Morphine 2000 ng/mL

c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the real time stability studies at both 4 ℃ and 30 ℃.

d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three batches of the device. Compounds that showed no interference at a concentration of 100ug/mL (albumin was tested at 100 mg/dL, ethanol at 1%) are summarized in the following tables.

Acetaminophen	ß-Estradiol	Oxalic acid
Acetophenetidin	Erythromycin	Oxolinic acid
N-Acetylprocainamide	Ethanol	Oxymetazoline
Acetylsalicylic acid	Fenoprofen	Papaverine
Albumin (100 mg/dL)	Furosemide	Penicillin G
Aminopyrine	Gentisic acid	Perphenazine
Amoxicillin	Hemoglobin	Phenelzine
Ampicillin	Hydralazine	Prednisone
Apomorphine	Hydrochlorothiazide	(±)-Propranolol
Ascorbic acid	Hydrocortisone	Pseudoephedrine
Aspartame	O-Hydroxyhippuric acid	Quinine
Atropine	3-Hydroxytyramine	Ranitidine
Benzilic acid	Ibuprofen	Salicylic acid
Benzoic acid	Isoproterenol	Serotonin (5- Hydroxytyramine)
Bilirubin	Isoxsuprine	Sulfamethazine
Chloral hydrate	Ketamine	Sulindac

8

Chloramphenicol	Ketoprofen	Tetrahydrocortisone 3-(β-Dglucuronide)
Chlorothiazide	Labetalol	Tetrahydrocortisone 3-acetate
Chlorpromazine	Loperamide	Tetrahydrozoline
Cholesterol	Meperidine	Thiamine
Clonidine	Meprobamate	Thioridazine
Cortisone	Methoxyphenamine	Triamterene
(-)-Cotinine	Nalidixic acid	Trifluoperazine
Creatinine	Naloxone	Trimethoprim
Deoxycorticosterone	Naltrexone	DL-Tryptophan
Dextromethorphan	Naproxen	Tyramine
Diclofenac	Niacinamide	DL-Tyrosine
Diflunisal	Nifedipine	Uric acid
Digoxin	Norethindrone	Verapamil
Diphenhydramine	Noscapine	Zomepirac
Ecgonine methyl ester	(±)-Octopamine

e. Specificity

To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device. The lowest concentration that caused a positive result for each compound are listed below for Morphine 2000 ng/mL cut-off. The data for Amphetamine, Oxazepam, Cocaine, Marijuana. Methamphetamine. Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine, Methadone, Nortriptyline and Propoxyphene were reported in K182530

Morphine, Cut-off=2000 ng/mL	Result	%Cross-Reactivity
Morphine	Positive at 2000 ng/mL	100%
Codeine	Positive at 200 ng/mL	1000%
Ethylmorphine	Positive at 2500 ng/mL	80%
Hydrocodone	Negative at 100000 ng/mL	50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/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. Summary results are shown below.

The results summary for AMP:

% of Cutoff	Number of	Drug Concentration	Lay person Results	The percentage of
-------------	-----------	--------------------	--------------------	-------------------

10

| | samples | by LC/MS/MS
(ng/mL) | No. of
Positive | No. of
Negative | correct results (%) |
|--------------|---------|------------------------|--------------------|--------------------|---------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 261 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 507 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 771 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1290 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 1560 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1870 | 20 | 0 | 100 |

The results summary for BAR:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75.9 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 150 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 220 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 360 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 429 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 501 | 20 | 0 | 100 |

The results summary for COC:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 81.5 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 151 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 395 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 455 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 520 | 20 | 0 | 100 |

The results summary for BUP:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	2.57	0	20	100
-50% Cutoff	160	5.14	0	160	100
-25% Cutoff	20	6.76	1	19	95
+25% Cutoff	20	12.8	18	2	90
+50% Cutoff	40	15.1	40	0	100
+75% Cutoff	20	17.2	20	0	100

The results summary for MET:

11

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	268	0	20	100
-50% Cutoff	160	526	0	160	100
-25% Cutoff	20	769	1	19	95
+25% Cutoff	20	1270	19	1	95
+50% Cutoff	40	1560	40	0	100
+75% Cutoff	20	1780	20	0	100

The results summary for MTD:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 76.8 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 147 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 226 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 441 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 504 | 20 | 0 | 100 |

The results summary for Morphine:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 535 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 1010 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 1580 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 2600 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 3050 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 3240 | 20 | 0 | 100 |

The results summary for OXY:

% of Cutoff	Number of samples	Drug Concentration by LC/MS/MS(ng/mL)	Lay person Results		The percentage of correct results (%)
			No. of Positive	No. of Negative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	24.5	0	20	100
-50% Cutoff	160	49.3	0	160	100
-25% Cutoff	20	71.1	1	19	95
+25% Cutoff	20	118	19	1	95
+50% Cutoff	40	147	40	0	100
+75% Cutoff	20	169	20	0	100

The results summary for PCP:

12

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 6.27 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 12.5 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 17.9 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 30.8 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 36.4 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 42.8 | 20 | 0 | 100 |

The results summary for THC:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 13 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 25.3 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 41 | 2 | 18 | 90 |
| +25% Cutoff | 20 | 65 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 79 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 93 | 20 | 0 | 100 |

The results summary for BZO:

| % of Cutoff | Number of
samples | Drug
Concentration by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 70.8 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 148 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 224 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 390 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 452 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 504 | 20 | 0 | 100 |

The results summary for MDMA:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 137 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 250 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 351 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 600 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 745 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 925 | 20 | 0 | 100 |

The results summary for TCA:

13

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 273 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 509 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 809 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1190 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 1510 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 1680 | 20 | 0 | 100 |

The results summary for PPX:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of
correct results
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 77.4 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 150 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 227 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 351 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 420 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 492 | 20 | 0 | 100 |

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.

3. Clinical Studies

Not applicable.

11. Conclusion

Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the device, it's concluded that the BIOEASY Multi-Drug Test Cup tests are substantially equivalent to the predicate.