CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests

• K Number: K161251
• Device Name: CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests
• Manufacturer: Hangzhou Clongene Biotech Co., Ltd
• Date Cleared: 2016-08-30 ( 119 days)
• Product Code: DKZ DIO JXM
• Regulation Number: 862.3100

Intended Use

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format. The tests provide 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 tests are intended for over-the-counter and for prescription use. CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format. The tests provide 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 tests are intended for over-the-counter and for prescription use. CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format. The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide 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 tests are intended for over-the-counter and for prescription use.

Device Description

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (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.

Predicate Devices

K052115

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on immunochromatographic assays and comparisons to GC/MS, with no mention of AI or ML.

Therapeutic

No

Explanation: The device is an in vitro diagnostic test for detecting substances in urine, not a device used for therapeutic purposes on a patient.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," which confirms its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device is described as immunochromatographic assays available in physical formats (Cassette, Cup, Dip Card, Split Key Cup) for testing urine samples. This indicates a physical, in vitro diagnostic device, not a software-only device.

IVD (In Vitro Diagnostic)

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

The document explicitly states "For in vitro diagnostic use only" multiple times in the "Intended Use / Indications for Use" section for all three tests (Amphetamine, Cocaine, and Oxazepam). This statement is a clear indicator that the device is intended for use in vitro (outside of the body) to diagnose or detect a condition or substance.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide 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 tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide 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 tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide 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 tests are intended for over-the-counter and for prescription use.

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

DKZ, JXM, DIO

Device Description

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

over-the-counter and for prescription use.

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

Not Found

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

Precision studies: 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 GC/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.

Cut-off study: A total of 150 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.

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.

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

Effect of Urine Specific Gravity and Urine pH study: 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.

Method comparison studies: 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to GC/MS results.

Lay-user study: Performed at three intended user sites with 1680 lay persons. 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.

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

1. Analytical Performance
   • Precision: Studies conducted at concentrations of -100%, -75%, -50%, -25%, +25%, +50%, +75%, and +100% of the cut-off, plus at the cut-off. Each concentration tested for 25 days, two runs per day. Results are summarized in tables showing the number of positive and negative results for each lot and concentration for Cassette, Dip Card, Split-Key Cup, and Easy Cup formats for Amphetamine, Cocaine, and Oxazepam tests. For Amphetamine, Cocaine, and Oxazepam tests, samples at -100%, -75%, -50%, and -25% cut-off consistently showed negative results (50-/0+), while samples at +25%, +50%, +75%, and +100% cut-off consistently showed positive results (50+/0-). Results at the cut-off varied, with a mix of positive and negative results across lots and device formats (e.g., Amphetamine Cassette Lot 1: 28-/22+, Lot 3: 20-/30+).
   • Linearity: Not applicable.
   • Stability: Stable at 4-30 °C for 24 months based on accelerated stability at 45 °C and real-time stability at 4 °C and 30 °C.
   • Cut-off: 150 samples (equally distributed at -50%, -25%, Cut-Off, +25%, +50% of Cut-Off) tested with three lots and three operators. All results were positive at and above +25% Cut-off and all negative at and below -25% Cut-off for Amphetamine, Cocaine, and Oxazepam. Verified cut-off values: d-Amphetamine 1000 ng/mL, Cocaine 300 ng/mL, Oxazepam 300 ng/mL.
   • Interference: Various physiological and pathological substances (over 100 compounds for each drug) tested at 100µg/mL with drug-free urine and urine at ±25% Cut-Off levels using three batches of each device. No interference observed.
   • Specificity: Tested using drug metabolites and other components. Lowest concentration causing a positive result for each compound is listed. For Amphetamine: L-Amphetamine (50000 ng/ml, 2%), Phentermine (3000 ng/ml, 33%), Hydroxyamphetamine (5000 ng/ml, 20%), MDA (5000 ng/ml, 20%), MDMA, D-methamphetamine, L-methamphetamine, Ephedrine, Pseudoephedrine (Negative at 100000,

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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

2016 August 30,

HANGZHOU CLONGENE BIOTECH CO., LTD C/O JESSE XIA MANAGER 504 E DIAMOND AVE., SUITE I GAITHERSBURG MD 20877

Re: K161251

Trade/Device Name: Clungene Amphetamine Tests, Clungene Cocaine Tests, Clungene Oxazepam Tests Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIO, JXM Dated: July 22, 2016 Received: July 27, 2016

Dear Mr. Xia:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney

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) K161251

Device Name Clungene Amphetamine Tests Clungene Cocaine Tests Clungene Oxazepam Tests

Indications for Use (Describe)

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide 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 tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The tests provide 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 tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide 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 tests are intended for over-the-counter and for prescription use.

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

X 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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510(k) SUMMARY

Email: [e-mail].

• 1. Date: August 29, 2016 Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China 3. Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: [phone]
• 4. Device Name: CLUNGENE Amphetamine Tests CLUNGENE Cocaine Tests CLUNGENE Oxazepam Tests

Classification:

Product Code	CFR #	Panel
DKZ	21 CFR, 862.3100 Amphetamine Test System	Toxicology
JXM	21 CFR, 862.3170 Benzodiazepine Test System	Toxicology
DIO	21 CFR, 862.3250 Cocaine Test System	Toxicology

5. Predicate Devices: K052115

The FIRST CHECK MULTI DRUG CUP Urine Test

6. Intended Use

CLUNGENE Amphetamine Tests are immunochromatographic assays for the qualitative determination of d-Amphetamine in human urine at cut-off concentration of 1000 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide 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 tests are intended for over-the-counter and for prescription use.

CLUNGENE Cocaine Tests are immunochromatographic assays for the qualitative determination of Cocaine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The tests provide 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.

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For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

CLUNGENE Oxazepam Tests are immunochromatographic assays for the qualitative determination of Oxazepam in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cassette format, a Cup format, a Dip Card format, and a Split Key Cup format.

The test may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses: it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must 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 tests are intended for over-the-counter and for prescription use.

• 7. Device Description
     The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam (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.
• 8. Substantial Equivalence Information
     A summary comparison of features of the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests and CLUNGENE Oxazepam Tests and the predicate devices is provided in following tables.

Item	Device	Predicate - K052115
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	d-Amphetamine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	1000 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 1: Features Comparison of CLUNGENE Amphetamine Tests and the Predicate Devices

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Table 2: Features Comparison of CLUNGENE Cocaine Tests and the Predicate Devices

Item	Device	Predicate - K052115
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	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	300 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

Table 3: Features Comparison of CLUNGENE Oxazepam Tests and the Predicate Devices

Item	Device	Predicate - K052115
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	Oxazepam	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Cut-Off Values	300 ng/mL	Same
Intended Use	For over-the-counter and prescription uses.	Same
Configurations	Cassette, Dip Card and Cups	Cup

9. Test Principle

The CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, and CLUNGENE Oxazepam Tests are rapid tests for the qualitative detection of d-Amphetamine, Cocaine and Oxazepam 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

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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 cutoffconcentration 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.

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 GC/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.

Cassette
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+	26-/24+	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-
Dip Card
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+	19-/31+	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+	22-/28+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup
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+	20-/30+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	31-/19+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup
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+	19-/31+	50+/0-	50+/0-	50+/0-	50+/0-

CLUNGENE Amphetamine Tests

Cassette

CLUNGENE Cocaine Tests

Cassette

| 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 |

---------------	------------------	-----------------	-----------------	----------------	---------	-----------------	-----------------	-----------------	------------------

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Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	30-/20+	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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	28-/22+	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-
Split-Key Cup
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	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+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	32-/18+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup
Lot	-100%	-75%	-50%	-25%		+25%	+50%	+75%	+100%
Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	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+	31-/19+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	23-/27+	50+/0-	50+/0-	50+/0-	50+/0-

CLUNGENE Oxazepam Tests

Cassette

	-100%	-75%	-50%	-25%	cut off	+25%	+50%	+75%	+100%
Cassette Number	cut off	cut off	cut off	cutoff	cut off	cut off	cut off	cut off	cut off
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	22-/28+	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+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Dip Card 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+	28-/22+	50+/0-	50+/0-	50+/0-	50+/0-
Split-Key Cup 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+	30-/20+	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+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Easy Cup 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+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

9

Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	21-/29+	50+/0-	50+/0-	50+/0-	50+/0-
-------	--------	--------	--------	--------	---------	--------	--------	--------	--------

b. Linearity

Not applicable.

• c. Stability
  The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C and real time stability determination at both 4 °C and 30 °C.

• d. Cut-off
  A total of 150 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 and Oxazepam. didata davia for the a

	The following cut-off values for the candidate devices have been verified.

Calibrator	Cut-off (ng/mL)
d-Amphetamine	1000
Cocaine	300
Oxazepam	300

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 are summarized in the following tables. There were no differences observed for different devices.

Amphetamine:

4-Acetamidophenol	Diazepam	O-Hydroxyhippuric acid
(-)-Cotinine	Diclofenac	Oxalic acid
(-)-Isoproterenol	Diflunisal	Oxazepam
(-)-Y-Ephedrine	Digoxin	Oxolinic acid
(±)-Chlorpheniramine	Diphenhydramine	Oxycodone
(IR,2S)-(-)-Ephedrine	Doxylamine	Oxymetazoline
3-Hydroxytyramine	Ecgonine hydrochloride	Papaverine
Acetophenetidin	Ecgonine methylester	Penicillin-G
Acetylsalicylic acid	Erythromycin	Pentazocaine
Aminopyrine	Estrone-3-sulfate	Pentobarbital
Amitriptyline	Ethyl-p-aminobenzoate	Perphenazine
Amobarbital	Fenfluramine	Phencyclidine
Amoxicillin	Fenoprofen	Phenelzine
Ampicillin	Furosemide	Phenobarbital

10

Ascorbic acid	Gentisic acid	Phenylpropanolamine
Aspartame	Hemoglobin	Prednisolone
Atropine	Hydralazine	Prednisone
Benzilic acid	Hydrochlorothiazide	Procaine
Benzoic acid	Hydrocodone	Promazine
Benzoylecgonine	Hydrocortisone	Promethazine
Bilirubin	Ibuprofen	Quinidine
Brompheniramine	Imipramine	Quinine
Caffeine	Isoxsuprine	Ranitidine
Cannabidiol	Ketamine	Salicylic acid
Cannabinol	Ketoprofen	Secobarbital
Chloralhydrate	L-Ephedrine	Sulfamethazine
Chloramphenicol	L-Phenylephrine	Sulindac
Chlordiazepoxide	Labetalol	Temazepam
Chloroquine	Levorphanol	Tetracycline
Chlorothiazide	Loperamide	Tetrahydrocortisone
Chlorpromazine	Maprotiline	Tetrahydrozoline
Cholesterol	Meperidine	Thebaine
Clomipramine	Meprobamate	Thiamine
Clonidine	Methadone	Thioridazine
Cocaine hydrochloride	Methylphenidate	Tolbutamine
Codeine	Morphine-3-D-glucuronide	Triamterene
Cortisone	N-Acetylprocainamide	Trifluoperazine
Creatinine	Nalidixic acid	Trimethoprim
D-Norpropox yphene	Naloxone	Trimipramine
D-Propoxyphene	Naltrexone	Tryptamine
D/L-Octopamine	Naproxen	Uric acid
D/L-Propanolol	Niacinamide	Verapamil
D/L-Thyroxine	Nifedipine	Zomepirac
D/L-Tyrosine	Norcodeine	ß-Estradiol
Deoxycorticosterone	Norethindrone	49-THC-COOH
Dextromethorphan	Noscapine

Cocaine

Acetaminophen	Diflunisal	Oxazepam
(-)-Cotinine	Digoxin	Oxolinic acid
(-)-Ψ-Ephedrine	Diphenhydramine	Oxycodone
(±)-3,4-Methylene
dioxyamphetamine	Doxylamine	Oxymetazoline
(±)-Brompheniramine	Ecgonine methylester	p-Hydroxymethamphetamine
(±)-Chlorpheniramine	Erythromycin	Papaverine
(±)-Isoproterenol	Estrone-3-sulfate	Penicillin-G
3-Hydroxytyramine	Ethyl-p-aminobenzoate	Pentobarbital
Acetophenetidin	Fenoprofen	Perphenazine
Acetylsalicylic acid	Furosemide	Phencyclidine
Aminopyrine	Gentisic acid	Phenelzine
Amitriptyline	Hemoglobin	Phenobarbital
Amobarbital	Hydralazine	Phentermine
Amoxicillin	hydrochloride	Phenylpropanolamine
Ampicillin	hydrochloride(±)-3,4-Methylene-
dioxymethamphetamine	Prednisolone
Apomorphine	Hydrochlorothiazide	Prednisone
Aspartame	Hydrocodone	Procaine
Atropine	Hydrocortisone	Promazine
Benzilic acid	Ibuprofen	Promethazine
Benzoic acid	Imipramine	Quinidine
Benzphetamine	Iproniazid	Quinine
Caffeine	Isoxsuprine	Ranitidine
Cannabidiol	Ketamine	Salicylic acid
Cannabinol	Ketoprofen	Secobarbital
Chloralhydrate	L-Ascorbic acid	Serotonin
Chloramphenicol	L-Phenylephrine	Sulfamethazine
Chlordiazepoxide	Labetalol	Sulindac
Chloroquine	Levorphanol	Temazepam
Chlorothiazide	Loperamide	Tetracycline
Chlorpromazine	Maprotiline	Tetrahydrocortisone
3 (β-D-glucuronide)
Cholesterol	Meperidine	Tetrahydrozoline
Clomipramine	Meprobamate	Thebaine
Clonidine	Methadone	Thiamine
Codeine	Methoxyphenamine	Thioridazine
Cortisone	Morphine Sulfate	Tolbutamide
Creatinine	Morphine-3-β-D-glucuronide	Triamterene
D-Norpropoxyphene	N-Acetylprocainamide	Trifluoperazine
D-Propoxyphene	Nalidixic acid	Trimethoprim
D-Pseudoephedrine	Naloxone	Trimipramine
D/L-Amphetamine Sulfate	Naltrexone	Tryptamine
D/L-Octopamine	Naproxen	Tyramine
D/L-Propranolol	Niacinamide	Uric acid
D/L-Tryptophan	Nifedipine	Verapamil
D/L-Tyrosine	Norcodeine	Zomepirac
Deoxycorticosterone	Norethindrone	ß-Estradiol
Dextromethorphan	Noscapine	β-Phenylethylamine
Diazepam	O-Hydroxyhippuric acid
Diclofenac	Oxalic acid

11

12

Oxazepam

4-Acetamidophenol	D-Propoxyphene	Naproxen
(-)-cotinine	D-Pseudoephedrine	Niacinamide
(-)-Y-Ephedrine	D/L-Amphetamine	Nifedipine
(+)-3,4-Methylenedioxy-
amphetamine	D/L-Octopamine	Norethindrone
(+)-3,4-Methylenedioxy-
methamphetamine	D/L-Propranolol	Noscapine
(±)-Chlorpheniramine	D/L-Tryptophan	O-Hydroxyhippuric acid
(±)-Chlorpheniramine	D/L-Tyrosine	Oxalic acid
(±)-Isoproterenol	Dextromethorphan	Oxolinic acid
3-Hydroxytyramine	Diclofenac	p-Hydroxy- methamphetamine
Acetophenetidin	Diflunisal	Pentobarbital
Acetylsalicylic acid	Digoxin	Perphenazine
Aminopyrine	Diphenhydramine	Phencyclidine
Amitriptyline	Doxylamine	Phenelzine
Amorbarbital	Ecgonine hydrochloride	Phenobarbital
Amoxicillin	Ecgonine methylester	Phentermine
Ampicillin	Fenoprofen	Phenylpropanolamine
Aporphine	Furosemide	Prednisone
Aspartame	Gentisic acid	Quinine
Atropine	Hemoglobin	Ranitidine
Benzilic acid	Hydrocortisone	Salicylic acid
Benzoic acid	Ibuprofen	Secobarbital
Benzoylecgonine	Imipramine	Serotonin (5-Hydroxytyramine)

13

Benzphetamine	Iproniazid	Sertraline
Bilirubin	Isoxsuprine	Sulfamethazine
Brompheniramine	Ketamine	Sulindac
Caffeine	Ketoprofen	Tetrahydrocortisone 3 ( β-D-glucuronide)
Caffeine	L-Ascorbic Acid	Tetrahydrozoline
Cannabidiol	L-Phenylephrine	Thiamine
Chloralhydrate	Labetalol	Thioridazine
Chloramphenicol	Loperamide	Tolbutamide
Chloroquine	Maprotiline	Triamterene
Chlorothiazide	Meperidine	Trifluoperazine
Chlorpromazine	Meprobamate	Trimethoprim
Cholesterol	Methadone	Tryptamine
Clomipramine	Methoxyphenamine	Tyramine
Clonidine	N-Acetylprocainamide	Uric acid
Cocaine hydrochloride	Nalidixic acid	Verapamil
Cortisone	Nalorphine	Zomepirac
Creatinine	Naloxone	β-Phenylethylamine
D-Norpropoxyphene	Naltrexone

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

Drugs	Concentration (ng/ml)	% Cross Reactivity
D - Amphetamine	1000	100%
L - Amphetamine	50000	2%
D/L - Amphetamine	3000	33%
Phentermine	3000	33%
Hydroxyamphetamine	5000	20%
Methylenedioxyamphetamine (MDA)	5000	20%
3,4-methylenedioxy-methamphetamine (MDMA)	Negative at 100000	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.

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

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/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	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	0	20	100%
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

22

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/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	250	0	20	100
-50% Cutoff	20	500	0	20	100
-25% Cutoff	20	750	1	19	95
+25% Cutoff	20	1250	19	1	95%
+50% Cutoff	20	1500	20	0	100
+75% Cutoff	20	1750	20	0	100

Comparison between GC/MS and Lay Person Results for Amphetamine Split-Key Cup

% of Cutoff	Number of samples	d-Amphetamine Concentration by GC/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	250	0	20	100%
-50% Cutoff	20	500	0	20	100%
-25% Cutoff	20	750	2	18	90%
+25% Cutoff	20	1250	18	2	90%
+50% Cutoff	20	1500	20	0	100%
+75% Cutoff	20	1750	20	0	100%

Comparison between GC/MS and Lay Person Results for Amphetamine Easy Cup

| % of Cutoff | Number
of
samples | d-Amphetamine
Concentration by GC/MS
(ng/mL) | Lay person results | | The percentage
of correct results
(%) |
|--------------|-------------------------|----------------------------------------------------|--------------------|----|---------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100% |
| -75% Cutoff | 20 | 250 | 0 | 20 | 100% |
| -50% Cutoff | 20 | 500 | 0 | 20 | 100% |
| -25% Cutoff | 20 | 750 | 1 | 19 | 95% |
| +25% Cutoff | 20 | 1250 | 18 | 2 | 90% |
| +50% Cutoff | 20 | 1500 | 20 | 0 | 100% |
| +75% Cutoff | 20 | 1750 | 20 | 0 | 100% |

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

% of Cutoff	Number of samples	Cocaine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
			No. of Positive	No. of Negative

23

-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Cocaine Dip Card

| % of Cutoff | Number
of
samples | Cocaine Concentration by
GC/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 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Cocaine Split-Key Cup

% of Cutoff	Number of samples	Cocaine Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Cocaine Easy Cup

| % of Cutoff | Number
of
samples | Cocaine Concentration by
GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|-------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |

24

+75% Cutoff	20	525	20	0	100
-------------	----	-----	----	---	-----

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

% of Cutoff	Number of samples	Oxazepam Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	0	20	100
+25% Cutoff	20	375	19	1	95
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Oxazepam Dip Card

% of Cutoff	Number of samples	Oxazepam Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	No. of Positive	No. of Negative	100
-75% Cutoff	20	75	0	20	100
-50% Cutoff	20	150	0	20	100
-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	20	0	100
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	20	0	100

Comparison between GC/MS and Lay Person Results for Oxazepam Split-Key Cup

| | Number
of
samples | Oxazepam Concentration
by GC/MS (ng/mL) | Lay person results | | The |
|--------------|-------------------------|--------------------------------------------|--------------------|--------------------|-----------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 225 | 2 | 18 | 90% |
| +25% Cutoff | 20 | 375 | 19 | 1 | 95 |
| +50% Cutoff | 20 | 450 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 525 | 20 | 0 | 100 |

Comparison between GC/MS and Lay Person Results for Oxazepam Easy Cup

| % of Cutoff | Number
of
samples | Oxazepam Concentration
by GC/MS (ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|--------------------------------------------|--------------------|----|------------------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 75 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 150 | 0 | 20 | 100 |

25

-25% Cutoff	20	225	1	19	95
+25% Cutoff	20	375	18	2	90
+50% Cutoff	20	450	20	0	100
+75% Cutoff	20	525	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 devices, it's concluded that the CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests and CLUNGENE Oxazepam Tests are substantially equivalent to the predicate.