CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene 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
Opiates	Morphine	2000 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
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. 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, Cocaine, Marijuana, Methamphetamine, Opiates, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene 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
Opiates	Morphine	2000 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
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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, Tricyclic Antidepressants, EDDP and Propoxyphene (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

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" as a single, consolidated table with pass/fail metrics. However, the "Performance Characteristics" section details various studies with implied performance targets. The key performance demonstrated is in the precision studies and lay-user studies for detecting drug analytes in urine at specific cut-off levels.

Implied Acceptance Criteria (based on presented data patterns):

Test	Acceptance Criteria (implied from data)	Reported Device Performance
Precision (EDDP, Opiates, Propoxyphene) - Dip Card & Easy Cup	All samples at -100%, -75%, -50%, -25% Cut-off should be Negative. All samples at +25%, +50%, +75%, +100% Cut-off should be Positive. Samples at Cut-off should show a mix of positive and negative results, indicating accurate determination around the cutoff.	Met: For all three analytes and both device types, samples at -100% to -25% Cut-off were 100% negative (50-/0+ for each lot). Samples at +25% to +100% Cut-off were 100% positive (50+/0- for each lot). At the Cut-off concentration, results were mixed (e.g., Dip Card EDDP Lot 1: 27-/23+), demonstrating ability to differentiate around the cutoff.
Interference	No interference at a concentration of 100 µg/mL for listed compounds.	Met: No differences observed between device types; comprehensive list of non-interfering compounds provided (e.g., Acetaminophen, Aspirin, Albumin, Hemoglobin).
Specificity (Cross-Reactivity)	List of compounds and their cross-reactivity percentages. Implied: High specificity for the target analyte (100% at cutoff), quantifiable cross-reactivity for structurally related compounds.	Met: High specificity shown for target analytes (e.g., EDDP 100% at 300 ng/mL, Morphine 100% at 2000 ng/mL, d-Propoxyphene 100% at 300 ng/mL). Cross-reactivity for related compounds is quantified at higher concentrations (e.g., Disopyramide 0.4% for EDDP, Thebaine 10% for Opiate).
Effect of Urine Specific Gravity and pH	All samples at or above +25% Cut-Off should be Positive. All samples at or below -25% Cut-Off should be Negative.	Met: "Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off." No differences observed between device types.
Lay-User Study (Overall Performance)	High percentage of correct results across all drug analytes and concentration levels. Instructions easily followed.	Met: The table for the lay-user study shows high percentages of correct results across all drugs and concentration levels, frequently 100% for clear negatives and positives, and 95% for those near the +/-25% cutoff. All lay users indicated that instructions were easily followed.
Lay-User Study (Reading Level)	Reading Grade Level should be appropriate for lay users.	Met: Flesch-Kincaid reading analysis showed a Grade Level of 7, which is generally considered appropriate for a broad lay audience.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size:
- Precision Studies: For EDDP, Opiates, and Propoxyphene, each concentration level (-100% to +100% cut-off) was tested with 50 samples for each of three lots, making a total of 450 tests per analyte per lot (50 samples * 9 concentrations) * 3 lots = 1350 tests per analyte. Since there are three analytes and two device types (Dip Card and Easy Cup), this would be 1350 tests * 3 analytes * 2 devices = 8100 individual tests for these three new analytes in the precision study.
- Method Comparison Studies: For EDDP, Opiates, and Propoxyphene, 80 unaltered clinical samples (40 negative and 40 positive) were used for each drug. This means 80 samples * 3 drugs * 2 device types = 480 samples.
- Lay-user Study: 310 lay persons were involved for each device format (Dip Card and Easy Cup). The total number of individual tests performed by lay users is not explicitly stated as a single number but would be 310 tests * 15 analytes * 2 device formats = 9300 tests (based on the "entire panel" evaluation). For each drug, a varying number of samples were prepared across different concentration levels, totaling 360 samples for Amphetamine, for example.
- Interference and Specificity Studies: Samples were "spiked into negative urine" and tested using three lots of each device. Numerical sample sizes are not provided for these, but rather the list of compounds and their effects.
- Effect of Urine Specific Gravity and pH: Urine samples were spiked with drugs at +/-25% Cut-Off levels and tested using three lots of each device. Numerical sample sizes are not provided.
Data Provenance: The document does not explicitly state the country of origin of the data for the experimental studies. However, the submitter, Hangzhou Clongene Biotech Co.,Ltd., is located in China, which might suggest the studies were conducted there. The clinical samples for the method comparison were "unaltered clinical samples." The lay-user study was performed "at three intended user sites."
Retrospective or Prospective: Not explicitly stated, but the precision, interference, specificity, and pH/specific gravity studies appear to be prospective, controlled laboratory studies. The method comparison using "unaltered clinical samples" suggests a prospective collection or at least a retrospective analysis of prospectively collected samples with LC/MS confirmation. The lay-user study appears to be prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: For the method comparison studies, the "in-house" tests were performed by "three laboratory assistants for each device." Their qualifications are not specified beyond being "laboratory assistants."
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The ground truth for the test set for the method comparison studies was established by LC/MS results, not by human expert adjudication of the device results themselves. The "Viewer" results (Viewer A, B, C) in the method comparison tables refer to the readings by the three laboratory assistants using the multi-drug test devices, which were then compared against the LC/MS ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was not explicitly stated as being performed in the context of comparing human readers with and without AI assistance.
The document describes a "Comparison Studies" section comparing the device's performance to LC/MS results, with three "viewers" (laboratory assistants) reading the device results. This is a form of multi-reader study, but it is a standalone performance assessment against a gold standard (LC/MS), not a comparative effectiveness study of human readers with and without AI.
Therefore, an effect size of how much human readers improve with AI vs. without AI assistance is not provided.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The devices (CLUNGENE Multi-Drug Test Dip Card and Easy Cup) are described as "competitive binding, lateral flow immunochromatographic assay" and are read visually. These are not AI-driven devices, and their performance inherently involves "human-in-the-loop" visual interpretation.
Therefore, a standalone (algorithm only) performance study was not done, as the device itself is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for all performance studies (e.g., Precision, Specificity, Method Comparison, Lay-user study) was established using Liquid Chromatography-Mass Spectrometry (LC/MS). For the precision study, samples were "prepared by spiking drug in negative urine samples" and "confirmed by LC/MS." For the method comparison study, "unaltered clinical samples" were "compared to LC/MS results."

8. The sample size for the training set

This information is not applicable. The CLUNGENE devices are immunoassay-based test kits, not machine learning or AI algorithms that require a "training set" in the computational sense. The "training" for the device refers to its manufacturing and validation processes, not data-driven algorithmic training.

9. How the ground truth for the training set was established

This information is not applicable as the device is not an AI/ML algorithm requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 21, 2019

Hangzhou Clongene Biotech Co.,Ltd. % Joe Shia, Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877

Re: K190412

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 Codes: NGL, PTG, QBF Dated: February 15, 2019 Received: February 21, 2019

Dear Joe Shia:

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

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 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)

K190412

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
Opiates	Morphine	2000 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
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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

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Methamphetamine	d-Methamphetamine	1000 ng/mL
Opiates	Morphine	2000 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
EDDP	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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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K190412 510(k) SUMMARY

The purpose of this submission is to add analytes 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Opiates and Propoxyphene to previously cleared device (K181790). These three new analytes were evaluated in this submission. For other analytes, please refer to K153741 for Methamphetamine, Morphine and Cannabinoids, and to K161251 for Amphetamine, Cocaine and Oxazepam, and to K180255 for Secobarbital, Methadone and Oxycodone, and K181790 for Methylenedioxymethamphetamine, Buprenorphine, Phencyclidine and Nortriptyline. In this submission the performance results are presented for the three new analytes, but the lay user study was conducted using the entire panel.

1. Date: March 19, 2019 2. Submitter: Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China 3. Contact person: Joe Shia LSI International Inc 504E Diamond Ave., Suite J Gaithersburg. MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.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
NGLMorphine	II	21 CFR § 862.3650, Opiate Test System	Toxicology (91)
PTG2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine	II	21 CFR § 862.3620, Methadone Test System	Toxicology (91)
QBFPropoxyphene	II	21 CFR, 862.3700 Propoxyphene Test System	Toxicology (91)

1. Predicate Devices: K180349
  The Assure Tech Panel Dip Tests/AssureTech Quick Cup Tests
1. Intended Use
  CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Opiates Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene in human urine at the cutoff concentrations of:

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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
Opiates	Morphine	2000 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
EDDP	(2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine)	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

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
Opiates	Morphine	2000 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

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Phencyclidine	Phencyclidine	25 ng/mL
Tricyclic Antidepressants	Nortriptyline	1000 ng/mL
EDDP	(2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine)	300 ng/mL
Propoxyphene	d-Propoxyphene	300 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, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

1. Device Description
  The 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, Tricyclic Antidepressants, EDDP and Propoxyphene (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.
1. 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.

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

Item	Device	Predicate - K180349
Indication(s)for Use	For the qualitative determination of drugs ofabuse in human urine.	Same (but the number ofdrugs detected is different)

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Calibrator andCut-Off Values	Amphetamine (AMP): 1,000 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/ml11-Nor-Δ 9-Tetrahydrocannabinol-9-COOH(THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMorphine (MOR): 2000ng/mLOxycodone(OXY) : 100 ng/mlSecobarbital (BAR): 300 ng/mlMethadone (MTD): 300 ng/mlBuprenorphine (BUP): 10 ng/mlD,L-Methylenedioxymethamphetamine(MDMA): 500 ng/mlPhencyclidine (PCP): 25 ng/mlNortriptyline (TCA): 1000 ng/ml2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/mlPropoxyphene (PPX): 300 ng/ml	Same
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 - K180349
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/ml	Same

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	D,L-Methylenedioxymethamphetamine(MDMA): 500 ng/ml
	Phencyclidine (PCP): 25 ng/ml
	Nortriptyline (TCA): 1000 ng/ml
	2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP): 300 ng/ml
	Propoxyphene (PPX): 300 ng/ml
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	Same
Type of Test	Qualitative
Specimen Type	Human Urine
Intended Use	For over-the-counter
Configurations	Cup	Dip Card

9. Test Principle

The CLUNGENE Multi-Drug Test Dip Card, and CLUNGENE Multi-Drug Test Easy Cup are rapid tests for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, 2-ethylidene-1,5dimethyl-3.3-diphenylpyrrolidine and Propoxyphene in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The 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 will not form in the test line region if the target drug level exceeds its cutoff-concentration because it will saturate all the binding sites of the antibody coated on the particles. A band should form in the control region of the devices regardless of the presence of drug or metabolite in the sample to indicate that the tests have been 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 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Opiates and Propoxyphene. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Oxycodone, Secobarbital, Methadone, Buprenorphine,

{9}------------------------------------------------

Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants were reported in K181790.

	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	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
	0	71.50	143.83	217.20	298.13	353.33	461.00	515.53	618.63
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-

EDDP
CLUNGENE Multi-Drug

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	Cut-off+25%	Cut-off+50%	Cut-off+75%	Cut-off+100%
LotNumber	0	71.50	143.83	217.20	298.13	353.33	461.00	515.53	618.63
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+	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-

Opiates

CLUNGENE Multi-Drug Test Dip Card

Concentration byLC/MS (ng/mL)Lot	-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
Number	0	492.7	985.7	1394.0	1941.8	2433.2	2876.9	3519.6	3873.9
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+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-

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	492.7	985.7	1394.0	1941.8	2433.2	2876.9	3519.6	3873.9
Lot 1	50-/0+	50-/0+	50-/0+	50-/0+	27-/23+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-/0+	50-/0+	26-/24+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 3	50-/0+	50-/0+	50-/0+	50-/0+	25-/25+	50+/0-	50+/0-	50+/0-	50+/0-

Propoxyphene 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	75.48	153.63	222.68	296.13	372.90	464.60	501.28	588.43
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-

{10}------------------------------------------------

Concentration byLC/MS (ng/mL)Lot	-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
Number	0	75.48	153.63	222.68	296.13	372.90	464.60	501.28	588.43
Lot 3	50-/0+	50-/0+	50-10+	50-/0+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
			CLUNGENE Multi-Drug Test Easy Cup
Concentration byLC/MS (ng/mL)Lot	-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
Number	0	75.48	153.63	222.68	296.13	372.90	464.60	501.28	588.43
Lot 1	50-/0+	50-10+	50-10+	50-10+	24-/26+	50+/0-	50+/0-	50+/0-	50+/0-
Lot 2	50-/0+	50-/0+	50-10+	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-

The following cut-off values are verified.

Drug (Identifier)	Cut-off level
2-ethylidene-1,5-dimethyl-3, 3-diphenylpyrrolidine (EDDP)	300 ng/mL
Opiates (OPI)	2000 ng/mL
Propoxyphene (PPX)	300 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 100µg/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	β-Estradiol	Oxalic acid
Acetophenetidin	Erythromycin	Oxolinic acid
N-Acetylprocainamide	Fenoprofen	Oxymetazoline
Acetylsalicylic acid	Furosemide	Papaverine
Albumin	Gentisic acid	Penicillin G
Aminopyrine	Hemoglobin	Perphenazine
Amoxicillin	Hydralazine	Phenelzine
Ampicillin	Hydrochlorothiazide	Prednisone
Apomorphine	Hydrocortisone	(±)-Propranolol
Ascorbic acid	O-Hydroxyhippuric acid	Pseudoephedrine
Aspartame	3-Hydroxytyramine	Quinine

{11}------------------------------------------------

Atropine	Ibuprofen	Ranitidine
Benzilic acid	Isoproterenol	Salicylic acid
Benzoic acid	Isoxsuprine	Serotonin (5- Hydroxytyramine)
Bilirubin	Ketamine	Sulfamethazine
Chloral hydrate	Ketoprofen	Sulindac
Chloramphenicol	Labetalol	Tetrahydrocortisone 3-(β- Dglucuronide)
Chlorothiazide	Loperamide	Tetrahydrocortisone 3-acetate
Chlorpromazine	Meperidine	Tetrahydrozoline
Cholesterol	Meprobamate	Thiamine
Clonidine	Methoxyphenamine	Thioridazine
Cortisone	Nalidixic acid	Triamterene
(-)-Cotinine	Naloxone	Trifluoperazine
Creatinine	Naltrexone	Trimethoprim
Deoxycorticosterone	Naproxen	DL-Tryptophan
Dextromethorphan	Niacinamide	Tyramine
Diclofenac	Nifedipine	DL-Tyrosine
Diflunisal	Norethindrone	Uric acid
Digoxin	Noscapine	Verapamil
Diphenhydramine	(±)-Octopamine	Zomepirac
Ecgonine methyl ester

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 for each compound are listed below for 2-ethylidene-1, 5-dimethyl-3, 3diphenylpyrrolidine, Opiates and Propoxyphene. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants were reported in K181790. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-

Drug Test Easy Cup.
EDDP(Cut-off=300 ng/mL)	ResultPositive at (ng/ml)	% Cross-Reactivity
EDDP (2-ethylidene-1,5-Dimethyl-3,3-diphenylpyrrolidine)	300	100%
Disopyramide	75000	0.4%
Doxylamine	75000	0.4%
LAAM (Levo-alpha-acetylmethadol)	>100000	<0.3%
Alpha Methadol	>100000	<0.3%
Methadone	>100000	<0.3%
EMDP (2-Ethyl-5-methyl-3,3-diphenylpyrroline)	>100000	<0.3%

Opiate	Result	%
(Cut-off=2000 ng/mL)	Positive at(ng/ml)	Cross-Reactivity
Morphine	2,000	100%
O6-Acetylmorphine	2,000	100%
Codeine	2,000	100%

{12}------------------------------------------------

Propoxypheneﺍ(1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1) (1An Andrews And	Result	0/01s

Thebaine	20,000	10%
Procaine	50,000	4%
Oxycodone	100,000	2%
Levorphanol	5,000	40%
Hydromorphone	10,000	20%
Heroin	2,000	100%
EthylMorphine	20,000	10%

r robov) Premo(Cut-off=300 ng/mL	11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11Positive at(ng/ml)	/ UCross-Reactivity
d-Propoxyphene	300	100%
Norpropoxyphene	300	100%

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 2-ethylidene-1, 5-diphenylpyrrolidine, Opiates and Propoxyphene. The data for Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Oxycodone, Secobarbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine and Tricyclic Antidepressants were reported in K181790.

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
ViewerB	Positive	0	0	1	20	20
	Negative	10	15	14	0	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	15	15	1	0

EDDP

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	EDDP10	285.53	Positive

{13}------------------------------------------------

Viewer B	EDDP98	284.15	Positive
Viewer A	EDDP39	318.03	Negative
Viewer C	EDDP39	318.03	Negative

CLUNGENEMulti-DrugTest EasyCup		Negative	Low Negative byLC/MS(less than-50%)	Near Cutoff Negative byLC/MS(Between-50% andcutoff)	Near Cutoff Positive 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	19	20
	Negative	10	15	14	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy CupViewer Results
Viewer A	EDDP98	284.15	Positive
Viewer C	EDDP10	285.53	Positive
Viewer A	EDDP39	318.03	Negative
Viewer B	EDDP07	330.83	Negative
Viewer C	EDDP39	318.03	Negative

Opiates

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	2	19	20
ViewerA	Negative	10	15	13	1	0
ViewerB	Positive	0	0	1	18	20
ViewerB	Negative	10	15	14	2	0
ViewerC	Positive	0	0	1	19	20
ViewerC	Negative	10	15	14	1	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	OPI35	1978.6	Positive
Viewer A	OPI51	1924.8	Positive
Viewer B	OPI51	1924.8	Positive
Viewer C	OPI35	1978.6	Positive

{14}------------------------------------------------

Viewer A	OPI66	2010.4	Negative
Viewer B	OPI66	2010.4	Negative
Viewer B	OPI57	2087.1	Negative
Viewer C	OPI57	2087.1	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	19	20
	Negative	10	15	14	1	0
ViewerC	Positive	0	0	2	18	20
	Negative	10	15	13	2	0

Discordant Results

Viewer	Sample Number	LC/MS Result	Easy CupViewer Results
Viewer A	OPI35	1978.6	Positive
Viewer A	OPI51	1924.8	Positive
Viewer B	OPI51	1924.8	Positive
Viewer C	OPI51	1924.8	Positive
Viewer C	OPI35	1978.6	Positive
Viewer A	OPI56	2061.2	Negative
Viewer A	OPI66	2010.4	Negative
Viewer B	OPI57	2087.1	Negative
Viewer C	OPI56	2061.2	Negative
Viewer C	OPI66	2010.4	Negative

Propoxyphene

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
ViewerB	Positive	0	0	1	19	20
	Negative	10	15	14	1	0
ViewerC	Positive	0	0	0	19	20
	Negative	10	15	15	1	0

{15}------------------------------------------------

Viewer	Sample Number	LC/MS Result	Dip CardViewer Results
Viewer A	PPX22	292.00	Positive
Viewer B	PPX22	292.00	Positive
Viewer A	PPX59	322.25	Negative
Viewer B	PPX62	334.73	Negative
Viewer C	PPX59	322.25	Negative

CLUNGENEMulti-DrugTest EasyCup		Negative	Low Negative byLC/MS(less than-50%)	Near Cutoff Negative byLC/MS(Between-50% andcutoff)	Near Cutoff Positive 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	18	20
	Negative	10	15	15	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	PPX22	292.00	Positive
Viewer C	PPX22	292.00	Positive
Viewer A	PPX59	322.25	Negative
Viewer B	PPX59	322.25	Negative
Viewer C	PPX59	322.25	Negative
Viewer B	PPX62	334.73	Negative

Lay-user study

A lay user study was performed at three intended user sites with 310 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, 1 blind labeled sample and a device. Each device was tested. Typical Results are shown below.

	% 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	170	500	0	170	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	170	150	0	170	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
	-100% Cut-off	20	0	0	20	100
COC	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
BZO	-50% Cut-off	170	150	0	170	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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	100
MET	-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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	100
	-25% Cut-off	20	225	0	20	100
MTD	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	100
	-25% Cut-off	20	225	0	20	100
	+25% Cut-off	20	375	19	1	95
OPI	+50% Cut-off	40	450	40	0	100
	+75% Cut-off	20	525	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	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
OXY	+75% Cut-off	20	525	20	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	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

THC	+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	170	25	0	170	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	170	500	0	170	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
	-100% Cut-off	20	0	0	20	100
BUP	-75% Cut-off	20	2.5	0	20	100
	-50% Cut-off	170	5	0	170	100
	-25% Cut-off	20	7.5	1	19	95
	+25% Cut-off	20	12.5	19	1	95
	+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
PCP	-75% Cut-off	20	6.25	0	20	100
	-50% Cut-off	170	12.5	0	170	100
	-25% Cut-off	20	18.75	1	19	95
	+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
MDMA	-50% Cut-off	170	250	0	170	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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	100
EDDP	-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
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	100
	-25% Cut-off	20	225	0	20	100
PPX	+25% Cut-off	20	375	19	1	95
	+50% Cut-off	40	450	40	0	100
	-100% Cut-off	20	0	0	20	100
	-75% Cut-off	20	75	0	20	100
	-50% Cut-off	170	150	0	170	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

CLUNGENE Multi-Drug Test

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(ﺎﺗﺎ ﺗﺎ		EA Eل ڪاري			Carlos Concession Company of Children
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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.

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).