(28 days)
No
The device description and performance studies indicate a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and visual interpretation, not AI/ML for analysis or interpretation. There is no mention of any computational analysis or algorithms.
No
Explanation: This device is an in vitro diagnostic tool used for qualitative drug detection in human urine, not for treating or preventing a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." and the "Device Description" section describes the products as "single-use in vitro diagnostic devices."
No
The device is described as an immunochromatographic assay using a lateral flow system, which is a physical test strip or cup, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use only." in the Intended Use / Indications for Use section for both the Dip Card and Easy Cup versions.
- "The products are single-use in vitro diagnostic devices." in the Device Description section.
N/A
Intended Use / Indications for 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, 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.
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.
Product codes
NGL, PTG, QBF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Analytical Performance - Precision Study:
- Study Type: Precision study
- Sample Size: For each concentration, tests were performed two runs per day for 25 days per device. This means a total of 50 tests per concentration level per device type (Dip Card and Easy Cup).
- Data Source: Samples were prepared by spiking drugs into negative urine samples. Each drug concentration was confirmed by LC/MS.
- Annotation Protocol: Sample aliquots were blindly labeled by the person who prepared the samples.
- Key Results: The results are summarized in tables showing agreement (number of negative/positive results) at various concentrations relative to the cutoff ( -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) for EDDP, Opiates, and Propoxyphene. For example, for EDDP (Dip Card, Lot 1), at -100% to -25% cutoff, results were 50-/0+ (50 negative, 0 positive), at cutoff it was 27-/23+, and for +25% to +100% cutoff, it was 50+/0-.
Analytical Performance - Linearity:
- Study Type: Linearity
- Key Results: Not applicable.
Analytical Performance - Stability:
- Study Type: Stability study (accelerated and real-time)
- Key Results: 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.
Analytical Performance - Interference:
- Study Type: Interference study
- Data Source: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug urine with concentrations at 25% below and 25% above Cut-Off levels.
- Key Results: No interference was observed for listed compounds at a concentration of 100µg/mL. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
Analytical Performance - Specificity:
- Study Type: Specificity study (cross-reactivity)
- Data Source: Drug metabolites and other structurally related compounds were spiked into negative urine.
- Key Results: The lowest concentrations causing a positive result and percentage cross-reactivity for EDDP, Opiates, and Propoxyphene are listed in tables. For example, Morphine (Opiate) showed 100% cross-reactivity at 2,000 ng/mL, and Thebaine showed 10% cross-reactivity at 20,000 ng/mL. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
Analytical Performance - Effect of Urine Specific Gravity and Urine pH:
- Study Type: Effect of Specific Gravity and pH study
- Data Source: Urine samples with 1.000 to 1.035 specific gravity or pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels.
- Key Results: All samples at and above +25% Cut-Off were positive, and all samples at and below -25% Cut-Off were negative. No differences were observed between device types.
Comparison Studies - In-house Method Comparison:
- Study Type: Method comparison studies
- Sample Size: 80 clinical samples (40 negative and 40 positive) for each drug were run by three laboratory assistants for each device.
- Data Source: Unaltered clinical samples.
- Annotation Protocol: Samples were blind-labeled and compared to LC/MS results.
- Key Results: Results are presented in tables showing the distribution of positive and negative results across different LC/MS concentration ranges (Negative, Low Negative, Near Cutoff Negative, Near Cutoff Positive, High Positive) for EDDP, Opiates, and Propoxyphene. Discordant results are individually listed with sample number, LC/MS result, and viewer result.
Lay-user study:
- Study Type: Lay user study
- Sample Size: 310 lay persons for each device format.
- Data Source: Urine samples prepared by spiking drugs into drug-free-pooled urine specimens, with concentrations confirmed by LC/MS.
- Annotation Protocol: Each participant was provided with the package insert, 1 blind labeled sample, and a device. Each device was tested.
- Key Results: Tables show the number of positive and negative results, and the percentage of correct results for each drug at various concentrations relative to the cutoff (-100% to +75% Cut-off). The majority of results show high percentages of correct outcomes (e.g., typically 95% or 100%). Lay users indicated that the device instructions could be easily followed, and a Flesch-Kincaid reading analysis showed a Grade Level of 7 for the package insert.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not explicitly stated as separate calculated metrics (Sensitivity, Specificity, PPV, NPV). However, the precision and comparison studies provide raw counts of positive/negative results at various concentrations relative to the cutoff, from which these metrics could be inferred. The lay user study directly provides "The percentage of correct results."
Predicate Device(s)
Reference Device(s)
K181790, K153741, K161251, K180255
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
CLUNGENE® Multi-Drug Test Dip Card CLUNGENE® Multi-Drug Test Easy Cup
Indications for Use (Describe)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of 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 |
3
| 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.
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. GC/MS or LC/MS is the preferred confirmatory method.
For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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.
-
- 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.
-
- Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NGL | |||
| Morphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| PTG | |||
| 2-ethylidene-1, 5- | |||
| dimethyl-3, 3- | |||
| diphenylpyrrolidine | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
| QBF | |||
| Propoxyphene | II | 21 CFR, 862.3700 Propoxyphene Test System | Toxicology (91) |
-
- Predicate Devices: K180349
The Assure Tech Panel Dip Tests/AssureTech Quick Cup Tests
- Predicate Devices: K180349
-
- 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:
- Intended Use
5
| 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.
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 | 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 |
6
| 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.
-
- 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.
- Device Description
-
- 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.
- Substantial Equivalence Information
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 of | |
| abuse in human urine. | Same (but the number of | |
| drugs detected is different) |
7
| Calibrator and
Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine(COC): 300 ng/ml
11-Nor-Δ 9-Tetrahydrocannabinol-9-COOH
(THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Morphine (MOR): 2000ng/mL
Oxycodone(OXY) : 100 ng/ml
Secobarbital (BAR): 300 ng/ml
Methadone (MTD): 300 ng/ml
Buprenorphine (BUP): 10 ng/ml
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 | Same |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Methodology | Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody
immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | 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 of | |
| drugs of abuse in human urine. | Same (but the number of | |
| drugs detected is different) | ||
| Calibrator and Cut-Off | ||
| Values | Amphetamine (AMP): 1,000 ng/ml | |
| Oxazepam (BZO):300 ng/ml | ||
| Cocaine(COC): 300 ng/ml | ||
| 11-Nor-△9-Tetrahydrocannabinol-9-COOH | ||
| (THC):50 ng/ml | ||
| Methamphetamine (MET): 1,000 ng/ml | ||
| Morphine (MOR): 300ng/mL | ||
| Oxycodone(OXY) : 100 ng/ml | ||
| Secobarbital (BAR): 300 ng/ml | ||
| Methadone (MTD): 300 ng/ml | ||
| Buprenorphine (BUP): 10 ng/ml | Same |
8
| | 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 flow
immunochromatographic assays based on
the principle of antigen antibody
immunochemistry. | 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
-
- 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 by | |||||||||
| LC/MS (ng/mL) | |||||||||
| Lot | |||||||||
| Number | -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 by | |||||||||
| LC/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% | |||||||||
| Lot | |||||||||
| Number | 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 by
LC/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 by
LC/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 |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
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+ | 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 by
LC/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 |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot
Number | 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 by
LC/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 by
LC/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) | Result | |
| Positive 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 | 100000 |
| | % of Cut-off | Number
of
samples | Concentration by
LC/MS
(ng/mL) | Lay person results | | The
percentage
of correct
results
(%) |
|--------------|---------------|-------------------------|--------------------------------------|--------------------|--------------------|---------------------------------------------------|
| Drugs | | | | No. of
Positive | No. of
Negative | |
| 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
16
17
18
| (
ﺎﺗﺎ ﺗﺎ | | EA E
ل ڪاري | | | Carlos Concession Company of Children |
| ------------- | -- | ---------------- | -- | -- | --------------------------------------- |
|---|
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.