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
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.

For in vitro diagnostic use only.

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.

AI/ML Overview

This document describes the validation study for the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup, which are in vitro diagnostic devices for the qualitative detection of various drugs in human urine.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the precision studies and the comparison studies. For the precision studies, the acceptance criterion is that samples significantly below the cutoff should test negative, samples significantly above the cutoff should test positive, and samples very close to the cutoff (e.g., +/- 25% of the cutoff) should show a mix of positive and negative results, reflecting the inherent variability at the decision point. For the comparison studies and lay-user studies, the implicit acceptance criterion is a high percentage of agreement with the reference method (LC/MS) or expected results, especially for samples far from the cutoff.

Here is a summary table, focusing on the precision study and lay-user study data as they most directly reflect performance against concentration levels:

Table of Acceptance Criteria and Reported Device Performance

Assay/Drug	Acceptance Criteria (Implicit)	Reported Device Performance (CLUNGENE Multi-Drug Test Dip Card & Easy Cup combined data where available)
Precision Study		See detailed tables in original document for each drug and lot.
All Drugs at -100% to -50% Cut-off (Precision)	All or nearly all samples should test Negative.	Observed: 50-/0+ for all concentrations from -100% to -50% cutoff across all lots and drugs (Buprenorphine, Methylenedioxymethamphetamine, Phencyclidine, Nortriptyline). This indicates 100% negative results.
All Drugs at +50% to +100% Cut-off (Precision)	All or nearly all samples should test Positive.	Observed: 50+/0- for all concentrations from +50% to +100% cutoff across all lots and drugs. This indicates 100% positive results.
All Drugs at Cut-off (Precision)	Results should show a mix of Positive and Negative, demonstrating performance at the cutoff. (e.g., ~50% P / ~50% N)	Observed: Mixed results at cutoff (e.g., Buprenorphine Dip Card: Lot 1: 24-/26+, Lot 2: 25-/25+, Lot 3: 28-/22+). Similar mixed results for other drugs/lots, demonstrating expected performance at cutoff.
Lay-User Study		See detailed tables in original document for each drug and concentration.
All Drugs at -100% to -50% Cut-off (Lay-user)	All or nearly all samples should test Negative (e.g., ≥95% correct).	Observed: 100% correct negative results for all drugs from -100% to -50% cutoff across both Dip Card and Easy Cup.
All Drugs at +50% to +75% Cut-off (Lay-user)	All or nearly all samples should test Positive (e.g., ≥95% correct).	Observed: 100% correct positive results for all drugs from +50% to +75% cutoff across both Dip Card and Easy Cup.
All Drugs at -25% Cut-off (Lay-user)	A high percentage of correct negative results (e.g., ≥90% correct is implied by the results).	Observed: Ranged from 90% to 100% correct negative results. Some drugs (e.g., AMP, COC, MET, MOP, OXY, TCA for Dip Card, or AMP, MET, BZO for Easy Cup) showed 95% or 90% correct.
All Drugs at +25% Cut-off (Lay-user)	A high percentage of correct positive results (e.g., ≥90% correct is implied by the results).	Observed: Ranged from 90% to 100% correct positive results. Some drugs (e.g., BAR, MTD, THC, for Dip Card, or AMP, BAR, TCA, MDMA for Easy Cup) showed 90% or 95% correct.
Overall Lay-User Ease of Use	All lay users should indicate instructions are easily followed.	All lay users indicated the device instructions can be easily followed. Flesch-Kincaid Grade Level was 7.

The study performed to prove the device meets acceptance criteria involved several components:

1. Sample Sizes and Data Provenance:

Test Set (Analytical Performance - Precision): For precision studies, for each drug and each concentration (-100% to +100% cut-off), 50 individual tests were performed across two runs per day for 25 days, for a total of 50 tests per concentration level per drug for each device type (Dip Card and Easy Cup). This was repeated for three different manufacturing lots.
Test Set (Comparison Studies): 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug. Data provenance is "in-house" suggesting the tests were conducted at the manufacturer's facility. The samples were "clinical samples," implying human origin, but specific country of origin or whether they were retrospectively collected or prospectively collected is not explicitly stated. They were "unaltered."
Test Set (Lay-User Study): 300 lay persons were involved for each device format (Dip Card and Easy Cup). Urine samples prepared at various concentrations (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cutoff) by spiking drugs into drug-free pooled urine specimens. The distribution of samples given to each participant is not explicitly detailed beyond "1 blind labeled sample and a device." The total number of individual tests performed in the lay-user study appears to be substantial given the breakdown of samples across concentrations for each drug and the 300 participants.
Data Provenance (General): While "in-house" is mentioned for comparison studies, specific origin countries or retrospective/prospective nature of the broader data (e.g., interference, specificity) are not explicitly stated, although given the manufacturer is based in China, it is likely data collection occurred there.

2. Number of Experts and Qualifications for Ground Truth - Test Set:

Experts: For the analytical (precision) and comparison studies, the ground truth for drug concentrations was established by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly sensitive and specific analytical chemistry method considered to be the "gold standard" for confirming drug concentrations in biological samples. Therefore, the "experts" in this context are the analytical chemists and laboratory personnel who performed and interpreted the LC/MS results. Their specific qualifications (e.g., number of years' experience, specific certifications) are not detailed in this document, but LC/MS analysis requires specialized training and expertise.
For the lay-user study, the ground truth for the spiked samples was also established by LC/MS.

3. Adjudication Method for the Test Set:

For the analytical (precision) studies, the samples were "blindly labeled by the person who prepared the samples and didn't take part in the sample testing." This indicates blinding, but no formal adjudication method (like 2+1 or 3+1 consensus) among different readers of the device results is mentioned, as the device results are qualitative (positive/negative) and read directly. The consistency across multiple lots and runs serves as a robustness check.
For the comparison studies, "three laboratory assistants" for each device ran the samples. Their individual results are reported in detail, showing where discrepancies from the LC/MS ground truth occurred for each viewer and sample. There is no explicit mention of an adjudication process among these three laboratory assistants for their readings of the device results; their individual performance is reported.
For the lay-user study, each of the 300 participants read their own single device. There was no reader adjudication among the lay users for their interpretation of the device results.

4. MRMC Comparative Effectiveness Study:

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was explicitly done in the typical sense of human readers with and without AI assistance. This device is a rapid, lateral flow immunochromatographic assay, not an AI-powered diagnostic imaging or algorithm. The "human readers" (laboratory assistants and lay users) are interpreting the visual lines on the test card/cup directly, not using "AI assistance."
Therefore, the concept of "effect size of how much human readers improve with AI vs without AI assistance" is not applicable to this type of device and study.

5. Standalone Performance:

Yes, a standalone performance study was done for the device itself. The precision studies directly evaluate the device's ability to correctly classify samples based on their concentration relative to the cutoff, independent of human interpretation variability (as the readings are a simple visual presence/absence of a line). The comparison studies similarly assess the device's performance against the gold standard (LC/MS) when read by trained laboratory professionals.

6. Type of Ground Truth Used:

The primary ground truth used for both analytical performance (precision, interference, specificity) and comparison studies was LC/MS (Liquid Chromatography-Mass Spectrometry). This is an objective chemical method that provides precise quantitative measurements of drug concentrations, which are then used to define positive or negative status relative to the established cutoff concentrations.
For the lay-user study, the ground truth for the spiked samples was also confirmed by LC/MS.

7. Sample Size for the Training Set:

This information is not provided in the document. As this is a rapid in vitro diagnostic device (immunochromatographic assay) and not an AI/machine learning algorithm, there isn't a "training set" in the computational sense. The device's performance relies on its biochemical design and manufacturing consistency rather than a trained model.

8. How Ground Truth for Training Set was Established:

As there is no "training set" for an AI model, this question is not applicable in the context of this device. The development of such devices typically involves extensive R&D, antibody selection, and optimization of chemical components, rather than data-driven training with a ground truth dataset in the way an AI algorithm would be.

Summary

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

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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

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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)

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.

For in vitro diagnostic use only.

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

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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.

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)

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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.
1. Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup

Classification:	Class 2
Product Code	Classification	Regulation Section	Panel
NFTAmphetamine	II	21 CFR § 862.3100, Amphetamine Test System	Toxicology(91)
NFWCannabinoids	II	21 CFR § 862.3870, Cannabinoids Test System	Toxicology(91)
NFYCocaine	II	21 CFR § 862.3250, Cocaine Test System	Toxicology(91)
NGGMethamphetamine	II	21 CFR § 862.3610,Methamphetamine Test System	Toxicology(91)
NGLMorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology(91)
NFVOxazepam	II	21 CFR § 862.3170,Benzodiazepine Test System	Toxicology(91)
NGLOxycodone	II	21 CFR § 862.3650, Opiate Test System	Toxicology(91)
PTHSecobarbital	II	21 CFR § 862.3150, Barbiturate Test System	Toxicology(91)
PTGMethadone	II	21 CFR § 862.3620, Methadone Test System	Toxicology(91)
NGLBuprenorphine	II	21 CFR § 862.3650,Opiate Test System	Toxicology(91)
NGGMethylenedioxy-methamphetamine	II	21 CFR § 862.3610, Methamphetamine Test System	Toxicology(91)
NGMPhencyclidine	unclassified	Enzyme Immunoassay Phencyclidine	Toxicology(91)
QAWNortriptyline	II	21 CFR, 862.3910 TricyclicAntidepressant Drugs Test System	Toxicology(91)

1. Predicate Devices: K142396
  The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
1. Intended Use

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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

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Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes.

For in vitro diagnostic use only.

1. 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)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 300ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD.L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25ng/mlNortriptyline (TCA): 1000ng/ml	Same

Table 1: Features Comparison of CLUNGENE Multi-Drug Test Dip Card and the
Predicate Devices

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Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry.	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)for Use	For the qualitative determination ofdrugs of abuse in human urine.	Same (but the number ofdrugs detected is different)
Calibrator and Cut-OffValues	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-△9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 300ng/mLOxycodone(OXY) : 100 ng/mLSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25ng/mlNortriptyline (TCA): 1000ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	For over-the-counter	Same
Configurations	Cup	Dip Card

1. Test Principle
  The CLUNGENE Multi-Drug Test Dip Card, and CLUNGENE Multi-Drug Test Easy Cup are

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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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
LotNumber	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 byLC/ MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
LotNumber	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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	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 byLC/MS (ng/mL)LotNumber	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
	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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	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 byLC/MS (ng/mL)	-100%Cut-off	-75%Cut-off	-50%Cut-off	-25%Cut-off	Cut-off	+25%Cut-off	+50%Cut-off	+75%Cut-off	+100%Cut-off
LotNumber	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(Cut-off=10 ng/mL)	ResultPositive 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(Cut-off=500 ng/mL)	ResultPositive at(ng/ml)	% Cross-Reactivity
Methylenedioxymethamphetamine(MDMA)	500	100%
3,4-Methylenedioxyamphetamine(MDA)	3000	17%
3,4-Methylenedioxyethylamphetamine(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(Cut-off=25 ng/mL)	ResultPositive at(ng/ml)	% Cross-Reactivity
Phencyclidine	25	100%
4-Hydroxyphencyclidine	12500	0.2%

Nortriptyline(Cut-off=1000 ng/mL)	ResultPositive 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}------------------------------------------------

CLUNGENEMulti-DrugTest Dip Card		Negative	Low Negative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerB	Positive	0	0	0	19	20
	Negative	10	15	15	1	0
ViewerC	Positive	0	0	1	20	20
	Negative	10	15	14	0	0

Viewer	Sample Number	LC/MS Result	Dip CardViewer 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

CLUNGENEMulti-DrugTest EasyCup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	15	14	2	0
ViewerC	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}------------------------------------------------

CLUNGENEMulti-DrugTest Dip Card		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	20	20
	Negative	10	15	14	0	0
ViewerB	Positive	0	0	0	20	20
	Negative	10	15	15	0	0
ViewerC	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

CLUNGENEMulti-DrugTest EasyCup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	20	20
ViewerA	Negative	10	15	14	0	0
ViewerB	Positive	0	0	1	19	20
ViewerB	Negative	10	15	14	1	0
ViewerC	Positive	0	0	1	20	20
ViewerC	Negative	10	15	14	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy CupViewer 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

CLUNGENEMulti-DrugTest Dip Card	Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+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 CardViewer 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

CLUNGENEMulti-DrugTest EasyCup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	1	18	20
ViewerA	Negative	10	15	14	2	0
ViewerB	Positive	0	0	1	20	20
ViewerB	Negative	10	15	14	0	0
ViewerC	Positive	0	0	1	20	20
ViewerC	Negative	10	15	14	0	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy CupViewer 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

CLUNGENEMulti-DrugTest Dip Card		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	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 CardViewer 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

CLUNGENEMulti-DrugTest EasyCup		Negative	LowNegative byLC/MS(less than-50%)	Near CutoffNegative byLC/MS(Between-50% andcutoff)	Near CutoffPositive byLC/MS(Between thecutoff and+50%)	High Positiveby LC/MS(greater than+50%)
ViewerA	Positive	0	0	2	18	20
	Negative	10	15	13	2	0
ViewerB	Positive	0	0	1	18	20
	Negative	10	15	14	2	0
ViewerC	Positive	0	0	1	19	20
	Negative	10	15	14	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy CupViewer 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	Numberofsamples	Concentration byLC/MS(ng/mL)	Lay person results		Thepercentageof correctresults(%)
Drugs				No. ofPositive	No. ofNegative
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
	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
BZO	-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	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
MET	-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	20	0	100
	+50% Cut-off	40	1500	40	0	100
	+75% Cut-off	20	1750	20	0	100
MTD	-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
MOP	-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	2	18	90
	+25% Cut-off	20	375	20	0	100
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
OXY	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	25	0	20	100
	-50% Cut-off	160	50	0	160	100
	-25% Cut-off	20	75	1	19	95
	+25% Cut-off	20	125	20	0	100
	+50% Cut-off	40	150	40	0	100
	+75% Cut-off	20	175	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	12.5	0	20	100
	-50% Cut-off	160	25	0	160	100
THC	-25% Cut-off	20	37.5	0	20	100
	+25% Cut-off	20	62.5	18	2	90
	+50% Cut-off	40	75	40	0	100
	+75% Cut-off	20	87.5	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	250	0	20	100
	-50% Cut-off	160	500	0	160	100
TCA	-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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	2.5	0	20	100
	-50% Cut-off	160	5	0	160	100
BUP	-25% Cut-off	20	7.5	0	20	100
	+25% Cut-off	20	12.5	20	0	100
	+50% Cut-off	40	15	40	0	100
	+75% Cut-off	20	17.5	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	6.25	0	20	100
	-50% Cut-off	160	12.5	0	160	100
PCP	-25% Cut-off	20	18.75	2	18	90
	+25% Cut-off	20	31.25	20	0	100
	+50% Cut-off	40	37.5	40	0	100
	+75% Cut-off	20	43.75	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	125	0	20	100
	-50% Cut-off	160	250	0	160	100
MDMA	-25% Cut-off	20	375	0	20	100
	+25% Cut-off	20	625	20	0	100
	+50% Cut-off	40	750	40	0	100
	+75% Cut-off	20	875	20	0	100
CLUNGENE Multi-Drug Test Easy Cup
	ofsamples	Concentration byLC/MS(ng/mL)	No. ofPositive	No. ofNegative	Thepercentage ofcorrectresults(%)
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	18	2	90
	+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	0	20	100
	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
BZO	-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
	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
MET	-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	2	18	90
	+25% Cut-off	20	1250	20	0	100
	+50% Cut-off	40	1500	40	0	100
	+75% Cut-off	20	1750	20	0	100
MTD	-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	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
MOP	-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
	+25% Cut-off	20	375	20	0	100

	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
OXY	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	25	0	20	100
	-50% Cut-off	160	50	0	160	100
	-25% Cut-off	20	75	1	19	95
	+25% Cut-off	20	125	20	0	100
	+50% Cut-off	40	150	40	0	100
	+75% Cut-off	20	175	20	0	100
THC	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	12.5	0	20	100
	-50% Cut-off	160	25	0	160	100
	-25% Cut-off	20	37.5	0	20	100
	+25% Cut-off	20	62.5	19	1	95
	+50% Cut-off	40	75	40	0	100
	+75% Cut-off	20	87.5	20	0	100
TCA	-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	18	2	90
	+50% Cut-off	40	1500	40	0	100
	+75% Cut-off	20	1750	20	0	100
BUP	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	2.5	0	20	100
	-50% Cut-off	160	5	0	160	100
	-25% Cut-off	20	7.5	0	20	100
	+25% Cut-off	20	12.5	20	0	100
	+50% Cut-off	40	15	40	0	100
	+75% Cut-off	20	17.5	20	0	100
PCP	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	6.25	0	20	100
	-50% Cut-off	160	12.5	0	160	100
	-25% Cut-off	20	18.75	0	20	100
	+25% Cut-off	20	31.25	20	0	100
	+50% Cut-off	40	37.5	40	0	100
	+75% Cut-off	20	43.75	20	0	100
MDMA	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	125	0	20	100
	-50% Cut-off	160	250	0	160	100
	-25% Cut-off	20	375	0	20	100
	+25% Cut-off	20	625	19	1	95
	+50% Cut-off	40	750	40	0	100
	+75% Cut-off	20	875	20	0	100

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

{19}------------------------------------------------

{20}------------------------------------------------

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.

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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 Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).