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, which relies on chemical reactions and visual interpretation of lines, not AI/ML for analysis or interpretation. There is no mention of any computational analysis or algorithms.

Therapeutic

No
This device is an in vitro diagnostic test for detecting drugs in urine, not for treating any condition.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." and the "Device Description" section describes the products as "single-use in vitro diagnostic devices."

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "immunochromatographic assay" using a "lateral flow system" and includes a "Test Device" and "urine cup for sample collection." These are physical components, not software.

IVD (In Vitro Diagnostic)

Yes, this 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 also states: "The products are single-use in vitro diagnostic devices."
Nature of the Test: The device performs a test on a biological sample (human urine) to detect the presence of specific substances (drugs and their metabolites) for diagnostic purposes (qualitative detection of drugs of abuse). This aligns with the definition of an in vitro diagnostic device.

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
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)

NFT, NFW, NFY, NGG, NGI, NFV, NGL, 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

human urine

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

Analytical Performance - Precision Study:

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.
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.
For each concentration, tests were performed two runs per day for 25 days per device in a randomized order.

Analytical Performance - Interference Study:

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.

Analytical Performance - Specificity Study:

Drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of each device.

Analytical Performance - 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.

Comparison Studies:

Method comparison studies performed in-house with three laboratory assistants for each device.
Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug.
Samples were blind labeled and compared to LC/MS results.

Lay-user study:

300 lay persons participated from three intended user sites.
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 of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

1. Analytical Performance
a. Precision

Study Type: Precision study
Sample Size: For each drug, tests were performed using 9 concentration levels: -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. For each concentration, tests were performed two runs per day for 25 days per device (total 50 tests per concentration per lot), using 3 lots. So results are 50-/0+ or 50+/0- or mixed at cutoff (e.g., 23-/27+).
Key Results:
- For Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, and Marijuana:
  - At -100%, -75%, -50% cut off, all samples were negative (50-/0+ across 3 lots).
  - At +25%, +50%, +75%, +100% cut off, all samples were positive (50+/0- across 3 lots).
  - At -25% cut off, almost all samples were negative (e.g., 50-/0+).
  - At cut off, there were mixed results (e.g., for Amphetamine Lot 1: 23-/27+; for Phencyclidine Lot 1: 28-/22+). This indicates appropriate performance around the cutoff.

b. Stability

Study Type: Stability study
Key Results: The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability determinations are ongoing at both 4 °C and 30 °C.

c. Interference

Study Type: Interference study
Key Results: A comprehensive list of compounds was tested (e.g., Acetaminophen, Ethanol, Ibuprofen, Salicylic acid) at 100µg/mL (albumin at 100 mg/dL) and showed no interference.

d. Specificity

Study Type: Specificity (Cross-reactivity) study
Key Results: Detailed tables are provided for each drug (Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxymethamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Cannabinoids) showing the result (positive at a specific concentration) and %Cross-Reactivity for various related and unrelated compounds. For example, for Amphetamine, L-Amphetamine showed 5% cross-reactivity, while for Buprenorphine, Norbuprenorphine showed 20%.

e. Effect of Urine Specific Gravity and Urine pH

Study Type: Effect of Urine Specific Gravity and Urine pH study
Key Results: Urine samples with specific gravity 1.000 to 1.035 and pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. No differences observed for different devices.

2. Comparison Studies

Study Type: Method comparison studies
Sample Size: 80 (40 negative and 40 positive) unaltered clinical samples for each drug.
Key Results: Detailed tables for each drug (Amphetamine, Secobarbital, Buprenorphine, Oxazepam, Cocaine, Methylenedioxy-methamphetamine, Methamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline, Marijuana) comparing results from three viewers (A, B, C) with LC/MS results. The tables show counts of true negatives, low negatives, near cutoff negatives, near cutoff positives, and high positives, as well as specific discordant results (sample number, LC/MS result, BIOEASY Cup Viewer Results). Generally, near cutoff samples show some variability as expected across the cutoff concentration.

Lay-user study

Study Type: Lay user study
Sample Size: 300 lay persons for the device.
Key Results: Summarized results for each drug (AMP, BAR, COC, BUP, MET, MTD, MOP, OXY, PCP, THC, BZO, MDMA, TCA, PPX) showing the number of samples, drug concentration by LC/MS/MS, number of positive and negative results by lay persons, and the percentage of correct results.
- For all drugs, 100% correct results were observed for -100%, -75%, -50%, +50%, and +75% cutoff concentrations.
- At -25% Cutoff, generally 95% correct results (1 positive and 19 negative out of 20 samples).
- At +25% Cutoff, generally 95% correct results (19 positive and 1 negative out of 20 samples) for most drugs, except TCA which was 90% (18 positive, 2 negative).
Lay-users surveys indicated that the device instructions can be easily followed. Flesch-Kincaid reading analysis showed a reading Grade Level of 7 for the package insert.

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

Not directly provided in calculated metrics like sensitivity, specificity, PPV, NPV. Instead, raw counts of true positives, true negatives, and discordant results are given for various concentration ranges (e.g., "50-/0+", "23-/27+") and comparisons against LC/MS for clinical samples and lay-user studies.

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.

K153050

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

§ 862.3100 Amphetamine test system.

(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Summary

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Build Correspondence

Image /page/0/Picture/2 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

November 9, 2018

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

Re: K182530

Trade/Device Name: BIOEASY Multi-Drug Test Cup Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: NFT, NFW, NFY, NGG, NGI, NFV, NGL, PTH, NGM, PTG, QAW, QBF Dated: September 9, 2018 Received: September 14, 2018

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

requirements, including, but not limited to: registration and listing (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Kellie B. Kelm -S

for Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182530

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
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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K182530 510(k) SUMMARY

November 9, 2018 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)

Predicate Devices: K153050

5

The CO-INNOVATION BIOTECH Rapid Multi-Drug Test Dip Card and Rapid 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
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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Item	Device	Predicate - K153050
Indication(s)
for Use	For the qualitative determination of
drugs of abuse in human urine.	Same (but the number of
drugs detected is different)
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 (MOR): 300ng/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
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

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

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 Propox yphene 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

7

regardless of the presence of drug or metabolite in the sample to indicate that the tests have been 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 tables.

Amphetamine

Lot Number	-100% cut off	-75% cut off	-50% cut off	-25% cutoff	cut off	+25% cut off	+50% cut off	+75% cut off	+100% cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-

Secobarbital

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Buprenorphine

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Oxazepam

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Cocaine

| 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+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- |

8

Methylenedioxy-methamphetamine

| 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- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/24+ | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- |

Methamphetamine

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Morphine

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Methadone

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Oxycodone

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +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+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Phencyclidine

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Propoxyphene

| 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Nortriptyline

9

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

Marijuana

| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | cut off | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |

c. Stability

The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability determinations are ongoing at both 4 °C and 30 °C.

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 each device. Compounds that showed no interference at a concentration of 100µg/mL (albumin was tested at 100 mg/dL) are summarized in the following tables.

Acetaminophen	β-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
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

10

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.

| AMP(Amphetamine)

(D - Amphetamine, Cut-off=1000 ng/mL)	Result	%Cross-Reactivity
D - Amphetamine	Positive at 1000 ng/mL	100%
L - Amphetamine	Positive at 20000 ng/mL	5%
DL - Amphetamine	Positive at 3000 ng/mL	33%
Phentermine	Positive at 30000 ng/mL	3.3%
Hydroxyamphetamine	Positive at 8000 ng/mL	12.5%
Methylenedioxyamphetamine (MDA)	Positive at 20000 ng/mL	5%
d-Methamphetamine	Positive> 100000 ng/mL	100000 ng/mL
Thebaine	Positive > 10000 ng/mL	100000ng/mL

The results summary for AMP:

| % of Cutoff | Number of
samples | Drug Concentration
by LC/MS/MS
(ng/mL) | Lay person Results
No. of Positive | Lay person Results
No. of Negative | The percentage of
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 | 19 | 1 | 95 |
| +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 |

23

| 00
. 7-0/
. | EAC
V International Comments of the Comments of Children of the Children Comments of the Children Children of the Children Children of the Children Children of the Children Child | | An
1 V V |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------|
| | | | |

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
(%) |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|---------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -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 | 19 | 1 | 95 |
| +50% Cutoff | 40 | 15.1 | 40 | 0 | 100 |
| +75% Cutoff | 20 | 17.2 | 20 | 0 | 100 |

The results summary for MET:

% 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 MOP:

| % of Cutoff | Number of
samples | Drug Concentration
by
LC/MS/MS(ng/mL) | Lay person Results | | The percentage of |
|--------------|----------------------|---------------------------------------------|--------------------|--------------------|------------------------|
| | | | No. of
Positive | No. of
Negative | correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 79 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 158 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 246 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 389 | 20 | 0 | 100 |
| +50% Cutoff | 40 | 469 | 40 | 0 | 100 |

24

+75% Cutoff	20	530	20	0	100
The results summary for OYY.

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:

| % 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 | 19 | 1 | 95 |
| +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	1	19	95
+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 |

25

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:

| % 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 | 273 | 0 | 20 | 100 |
| -50% Cutoff | 160 | 509 | 0 | 160 | 100 |
| -25% Cutoff | 20 | 809 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1190 | 18 | 2 | 90 |
| +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.

1. 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.