CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Device Facts
| Record ID | K181790 |
|---|---|
| Device Name | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
| Applicant | Hangzhou Clongene Biotech Co., Ltd. |
| Product Code | NGL · Clinical Toxicology |
| Decision Date | Jul 26, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3650 |
| Device Class | Class 2 |
Intended Use
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only. CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of: [Table of drugs and cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Device Story
Single-use lateral flow immunochromatographic assays for qualitative detection of drugs of abuse in human urine. Device formats include Dip Card and Easy Cup. Principle: competitive binding; urine sample migrates via capillary action; target drugs below cutoff do not saturate monoclonal antibody binding sites, allowing formation of visible colored test line; drugs above cutoff saturate binding sites, preventing test line formation. Control line forms to verify proper test performance. Used in home or point-of-care settings by lay users. Results are visual; positive results are preliminary and require confirmation via GC/MS or LC/MS. Provides rapid screening for clinical consideration.
Clinical Evidence
No clinical studies performed. Evidence consists of bench testing (precision, interference, specificity, stability) and a lay-user study. Lay-user study included 300 participants per device format (ages 18 to >50) using spiked urine samples confirmed by LC/MS. Results showed high concordance with expected values across all drug analytes and concentrations.
Technological Characteristics
Lateral flow immunochromatographic assay; competitive binding principle. Single-use device. Components: Dip Card or Easy Cup, package insert, urine collection cup. Sealed in aluminum pouch with desiccant. No electronic components or software.
Indications for Use
Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, MDMA, Tricyclic Antidepressants) in human urine. Intended for over-the-counter (OTC) use. Not intended to distinguish between prescription use and abuse.
Regulatory Classification
Identification
An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.
Special Controls
*Classification.* Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
Predicate Devices
- The Chemtrue® Multi-Panel Drug Screen Dip Card Tests (K142396)
Related Devices
- K170049 — AssureTech Panel Dip Test, AssureTech Quick Cup Test · Assure Tech. (Hangzhou) Co, Ltd. · May 2, 2017
- K201120 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · May 27, 2020
- K182654 — SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card · Safecare Biotech (Hangzhou) Co., Ltd. · Nov 19, 2018
- K180349 — AssureTech Panel Dip Tests, AssureTech Quick Cup Tests · Assure Tech. (Hangzhou) Co, Ltd. · Apr 5, 2018
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 26, 2018
Hangzhou Clongene Biotech Co.,Ltd. % Jesse Xia Manager LSI International 504 E Diamond Ave, Suite I Gaithersburg, MD 20877
Re: K181790
Trade/Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL, NGG, OAW, NGM Dated: June 25, 2018 Received: July 5, 2018
Dear Jesse Xia:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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
{2}------------------------------------------------
#### Indications for Use
510(k) Number (if known) k181790
#### Device Name
CLUNGENE® Multi-Drug Test Dip Card CLUNGENE® Multi-Drug Test Easy Cup
#### Indications for Use (Describe)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|-------------------------------|---------------------------------------|---------------|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|------------------|---------------------------------------|---------------|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
{3}------------------------------------------------
| Oxycodone | Oxycodone | 100 ng/mL |
|-------------------------------|-----------------------------------|------------|
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital, Nortriptyline 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. GCMS 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
### k181790
#### 510(k) SUMMARY
- 1. Date: July 25, 2018 2. Submitter: Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China
- Zheng Shujian 3. Contact person: Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: 86 571 88262120 Email: frank@clongene.com.
- 4. Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup
| Classification: | Class 2 | | |
|-------------------------------------------|----------------|----------------------------------------------------------------|--------------------|
| Product Code | Classification | Regulation Section | Panel |
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology<br>(91) |
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology<br>(91) |
| NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine Test System | Toxicology<br>(91) |
| NGG<br>Methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology<br>(91) |
| NGL<br>Morphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology<br>(91) |
| NFV<br>Oxazepam | II | 21 CFR § 862.3170,<br>Benzodiazepine Test System | Toxicology<br>(91) |
| NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology<br>(91) |
| PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology<br>(91) |
| PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology<br>(91) |
| NGL<br>Buprenorphine | II | 21 CFR § 862.3650,<br>Opiate Test System | Toxicology<br>(91) |
| NGG<br>Methylenedioxy-<br>methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology<br>(91) |
| NGM<br>Phencyclidine | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology<br>(91) |
| QAW<br>Nortriptyline | II | 21 CFR, 862.3910 Tricyclic<br>Antidepressant Drugs Test System | Toxicology<br>(91) |
- 5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
- 6. Intended Use
{5}------------------------------------------------
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:
| Drug | Calibrator | Cut-off |
|-------------------------------|---------------------------------------|------------|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9 COOH | 50 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital. Nortriptyline 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.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in human urine at the cutoff concentrations of:
| Drug | Calibrator | Cut-off |
|-------------------------------|---------------------------------------|------------|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9 COOH | 50 ng/mL |
| Buprenorphine | Buprenorphine | 10 ng/mL |
| Methylenedioxymethamphetamine | D,L-Methylenedioxymethamphetamine | 500 ng/mL |
| Phencyclidine | Phencyclidine | 25 ng/mL |
| Tricyclic Antidepressants | Nortriptyline | 1000 ng/mL |
{6}------------------------------------------------
Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.
The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Secobarbital. Nortriptyline 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.
- 7. Device Description
The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The CLUNGENE Multi-Drug Test Dip Card kit contains a Dip Card device, a package insert and a urine cup for sample collection. The CLUNGENE Multi-Drug Test Easy Cup kit contains a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.
#### 8. Substantial Equivalence Information
A summary comparison of features of the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup and the predicate devices is provided in following tables.
| Item | Device | Predicate - K142396 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>11-Nor-△9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>D.L-Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml<br>Phencyclidine (PCP): 25ng/ml<br>Nortriptyline (TCA): 1000ng/ml | Same |
| Table 1: Features Comparison of CLUNGENE Multi-Drug Test Dip Card and the | | | | |
|---------------------------------------------------------------------------|--|--|--|--|
| Predicate Devices | | | | |
{7}------------------------------------------------
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------|------|
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Dip Card | Same |
| Table 2: Features Comparison of CLUNGENE Multi-Drug Test Easy Cup Tests and the | | | |
|---------------------------------------------------------------------------------|--|--|--|
| Predicate Devices | | | |
| Item | Device | Predicate - K142396 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
| Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>11-Nor-△9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone(OXY) : 100 ng/mL<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>D,L-Methylenedioxymethamphetamine<br>(MDMA): 500 ng/ml<br>Phencyclidine (PCP): 25ng/ml<br>Nortriptyline (TCA): 1000ng/ml | Same |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Dip Card |
- 9. Test Principle
The CLUNGENE Multi-Drug Test Dip Card, and CLUNGENE Multi-Drug Test Easy Cup are
{8}------------------------------------------------
rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration. it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its 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. cut off. +25% cut off. +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine 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 for Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine Nortriptyline. The data for Methamphetamine, Morphine, Marijuana, and Amphetamine, Oxazepam, Cocaine, Secobarbital, Methadone and Oxycodone were reported in k180255.
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 2.65 | 5.01 | 7.74 | 10.47 | 12.68 | 14.58 | 16.62 | 20.30 |
| 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+ | 25-/25+ | 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
CLUNGENE Multi-Drug Test Easy Cup
CLUNGENE Multi-Drug Test Dip Card
| Concentration by<br>LC/ MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 2.65 | 5.01 | 7.74 | 10.47 | 12.68 | 14.58 | 16.62 | 20.30 |
| 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+ | 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- |
#### Methylenedioxymethamphetamine
CLUNGENE Multi-Drug Test Dip Card
{9}------------------------------------------------
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 121 | 259 | 394 | 517 | 634 | 747 | 861 | 960 |
| 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+ | 26-/24+ | 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- |
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
| Lot<br>Number | 0 | 121 | 259 | 394 | 517 | 634 | 747 | 861 | 960 |
| 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+ | 25-/25+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Phencyclidine CLUNGENE Multi-Drug Test Dip Card
| Concentration by<br>LC/MS (ng/mL)<br>Lot<br>Number | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|----------------------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| | 0 | 5.8 | 13.0 | 19.2 | 25.9 | 32.0 | 37.1 | 43.6 | 49.9 |
| 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+ | 26-/24+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## CLUNGENE Multi-Drug Test Easy Cup
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 5.8 | 13.0 | 19.2 | 25.9 | 32.0 | 37.1 | 43.6 | 49.9 |
| 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+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
## Nortriptyline
CLUNGENE Multi-Drug Test Dip Card
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 258 | 529 | 788 | 1054 | 1262 | 1476 | 1692 | 1929 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 18-/32+ | 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+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Multi-Drug Test Easy Cup
{10}------------------------------------------------
| Concentration by<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 258 | 529 | 788 | 1054 | 1262 | 1476 | 1692 | 1929 |
| 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+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The following cut-off values are verified.
| Drug(Identifier) | Cut-off level |
|--------------------------------------|---------------|
| Buprenorphine (BUP) | 10 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Phencyclidine (PCP ) | 25 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
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. Real time stability studies are ongoing.
#### 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 lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Acetaminophen (4-Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
|-----------------------------------|------------------------|--------------------------------|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
{11}------------------------------------------------
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
|---------------------|------------------|-----------------------------------------|
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- Dglucuronide) |
| Cholesterol | Loperamide | Tetrahydrozoline |
| Clonidine | Maprotiline | Thiamine |
| Cortisone | Meperidine | Thioridazine |
| (-) Cotinine | Meprobamate | Triamterene |
| Creatinine | Methoxyphenamine | DL-Tyrosine |
| Deoxycorticosterone | Nalidixic acid | Trifluoperazine |
| Dextromethorphan | Naloxone | Trimethoprim |
| Diclofenac | Naltrexone | D L-Tryptophan |
| Diflunisal | Naproxen | Tyramine |
| Digoxin | Niacinamide | Uric acid |
| Diphenhydramine | Nifedipine | Verapamil |
| Disopyramide | Norethindrone | Zomepirac |
| EDDP | Noscapine | |
To demonstrate that there is no interference from each of the thirteen drug analytes on the other twelve drug strips, devices in both CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup were tested using standard drug urine solutions at three fold cut-off drug concentrations of each drug analyte. Tests showed positive result only for each target drug and negative result for other drugs.
#### e. Specificity
To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result each listed for for Buprenorphine. for Methylenedioxymethamphetamine, Phencyclidine and Nortriptyline. The data for Methamphetamine, Morphine, Marijuana, Amphetamine, Oxazepam, Cocaine, Secobarbital, Methadone and Oxycodone were reported in k180255. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Buprenorphine<br>(Cut-off=10 ng/mL) | Result<br>Positive at (ng/mL) | % Cross-Reactivity |
|-------------------------------------|-------------------------------|--------------------|
| Buprenorphine | 10 | 100% |
| Buprenorphine -3-D-Glucuronide | 15 | 67% |
| Norbuprenorphine | 20 | 50% |
| Norbuprenorphine-3-D-Glucuronide | 200 | 5% |
| Morphine | >100000 | <0.01% |
| Oxymorphone | >100000 | <0.01% |
| Hydromorphone | >100000 | <0.01% |
| Methylenedioxymethamphetamine<br>(Cut-off=500 ng/mL) | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|------------------------------------------------------|------------------------------|--------------------|
| Methylenedioxymethamphetamine<br>(MDMA) | 500 | 100% |
| 3,4-Methylenedioxyamphetamine<br>(MDA) | 3000 | 17% |
| 3,4-<br>Methylenedioxyethylamphetamine<br>(MDEA) | 1000 | 50% |
{12}------------------------------------------------
| d-methamphetamine | >100000 | <0.5% |
|-------------------|---------|-------|
| d-amphetamine | >100000 | <0.5% |
| l-amphetamine | >100000 | <0.5% |
| l-methamphetamine | >100000 | <0.5% |
| Phencyclidine<br>(Cut-off=25 ng/mL) | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|-------------------------------------|------------------------------|--------------------|
| Phencyclidine | 25 | 100% |
| 4-Hydroxyphencyclidine | 12500 | 0.2% |
| Nortriptyline<br>(Cut-off=1000 ng/mL) | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|---------------------------------------|------------------------------|--------------------|
| Nortriptyline | 1,000 | 100% |
| Amitriptyline | 1,500 | 67% |
| Clomipramine | 12,500 | 8% |
| Desipramine | 200 | 500% |
| Doxepin | 2,000 | 50% |
| Imipramine | 400 | 250% |
| Maprotiline | 2,000 | 50% |
| Nordoxepin | 1,000 | 100% |
| Promazine | 1,500 | 67% |
| Promethazine | 25,000 | 4% |
| Trimipramine | 3,000 | 33% |
| Cyclobenzaprine Hydrochloride | 5,000 | 20% |
| Norclomipramine | 50,000 | 2% |
#### f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
#### 2. Comparison Studies
Method comparison studies for the CLUNGENE Multi-Drug Test Dip Card and the CLUNGENE Multi-Drug Test Easy Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to LC/MS results. The results are presented in the tables below for Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine and Nortriptyline. The data for Methamphetamine, Morphine, Marijuana, Amphetamine, Oxazepam, Cocaine, Secobarbital, Methadone and Oxycodone were reported in k180255.
#### Buprenorphine
{13}------------------------------------------------
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 19 | 20 |
| | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | BUP46 | 9.91 | Positive |
| Viewer C | BUP51 | 9.66 | Positive |
| Viewer A | BUP06 | 10.15 | Negative |
| Viewer B | BUP06 | 10.15 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
#### Discordant Results
| Viewer | Sample Number | LC/MS Result | Easy Cup Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | BUP46 | 9.91 | Positive |
| Viewer B | BUP46 | 9.91 | Positive |
| Viewer C | BUP65 | 9.50 | Positive |
| Viewer A | BUP21 | 10.51 | Negative |
| Viewer B | BUP73 | 10.00 | Negative |
| Viewer B | BUP06 | 10.15 | Negative |
| Viewer C | BUP73 | 10.00 | Negative |
| Viewer C | BUP56 | 10.20 | Negative |
Methylenedioxymethamphetamine
{14}------------------------------------------------
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 20 | 20 |
| | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Sample Number | LC/MS Result | Dip Card Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | MDMA23 | 450.60 | Positive |
| Viewer C | MDMA06 | 467.66 | Positive |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 14 | 0 | 0 |
## Discordant Results
| Viewer | Sample Number | LC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | MDMA06 | 467.66 | Positive |
| Viewer B | MDMA06 | 467.66 | Positive |
| Viewer C | MDMA23 | 450.60 | Positive |
| Viewer B | MDMA35 | 535.50 | Negative |
# Phencyclidine
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
|-----------------------------------------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
{15}------------------------------------------------
| Viewer | Positive | 0 | 0 | 1 | 18 | 20 |
|--------|----------|----|----|----|----|----|
| A | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| C | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | PCP13 | 24.24 | Positive |
| Viewer B | PCP33 | 24.31 | Positive |
| Viewer C | PCP13 | 24.24 | Positive |
| Viewer A | PCP23 | 28.97 | Negative |
| Viewer A | PCP22 | 26.23 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 18 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 14 | 0 | 0 |
# Discordant Results
| Viewer | Sample Number | LC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | PCP33 | 24.31 | Positive |
| Viewer B | PCP13 | 24.24 | Positive |
| Viewer C | PCP13 | 24.24 | Positive |
| Viewer A | PCP48 | 25.98 | Negative |
| Viewer A | PCP22 | 26.23 | Negative |
# Nortriptyline
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
{16}------------------------------------------------
| Viewer | | 0 | 0 | 1 | 19 | 20 |
|--------|----------|----|----|----|----|----|
| B | Positive | 0 | 0 | 1 | 19 | 20 |
| B | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer | | 0 | 0 | 1 | 19 | 20 |
| C | Positive | 0 | 0 | 1 | 19 | 20 |
| C | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer | Sample Number | LC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | TCA35 | 914.06 | Positive |
| Viewer B | TCA70 | 957.46 | Positive |
| Viewer C | TCA70 | 957.46 | Positive |
| Viewer A | TCA01 | 1164.20 | Negative |
| Viewer B | TCA18 | 1051.60 | Negative |
| Viewer C | TCA06 | 1057.60 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>LC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>LC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>LC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by LC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 15 | 13 | 2 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 18 | 20 |
| | Negative | 10 | 15 | 14 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
#### Discordant Results
| Viewer | Sample Number | LC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | TCA70 | 957.46 | Positive |
| Viewer A | TCA35 | 914.06 | Positive |
| Viewer B | TCA70 | 957.46 | Positive |
| Viewer C | TCA70 | 957.46 | Positive |
| Viewer A | TCA06 | 1057.60 | Negative |
| Viewer A | TCA18 | 1051.60 | Negative |
| Viewer B | TCA18 | 1051.60 | Negative |
| Viewer B | TCA12 | 1082.20 | Negative |
| Viewer C | TCA06 | 1057.60 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 300 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert,
{17}------------------------------------------------
1 blind labeled sample and a device. Each device was tested. Results are shown below. CLUNGENE Multi-Drug Test Dip Card
| | % of Cut-off | Number<br>of<br>samples | Concentration by<br>LC/MS<br>(ng/mL) | Lay person results | | The<br>percentage<br>of correct<br>results<br>(%) |
|-----------------------------------|---------------|--------------------------------------|--------------------------------------|--------------------|---------------------------------------------------|---------------------------------------------------|
| Drugs | | | | No. of<br>Positive | No. of<br>Negative | |
| AMP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 250 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 500 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 750 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 1250 | 19 | 1 | 95 |
| | +50% Cut-off | 40 | 1500 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 1750 | 20 | 0 | 100 |
| BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 375 | 18 | 2 | 90 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| COC | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 1 | 19 | 95 |
|…
