(29 days)
No
The device description and performance studies indicate a standard lateral flow immunochromatographic assay, which relies on chemical reactions and visual interpretation, not AI/ML for analysis or result interpretation. There is no mention of AI, ML, or image processing.
No
The device is described as a qualitative and simultaneous detection assay for various drugs in human urine, providing only preliminary test results. It is an in vitro diagnostic device, not intended for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only," and the "Device Description" calls the products "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. The description explicitly mentions physical components like a Dip Card device, a Cup device, and a urine cup for sample collection. This indicates it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the Dip Card and Easy Cup explicitly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section also states: "The products are single-use in vitro diagnostic devices."
- Nature of the Test: The device performs a qualitative and simultaneous detection of various drugs in human urine. This is a diagnostic test performed on a biological sample (urine) outside of the body (in vitro).
- Performance Studies: The document describes performance studies, including precision studies, comparison studies (comparing results to GC/MS), and a lay-user study. These types of studies are typical for demonstrating the performance of an IVD.
- Predicate Device: A predicate device (K142396 The Chemtrue® Multi-Panel Drug Screen Dip Card Tests) is listed, which is a common requirement for regulatory submissions of IVDs.
All of these points strongly indicate that the CLUNGENE® Multi-Drug Test Dip Card and Easy Cup are intended and classified as In Vitro Diagnostic devices.
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, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
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 Oxazepam, Secobarbital 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, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
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 Oxazepam, Secobarbital 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
PTH, PTG, NGL, NGG, NFT, NFW, NFY, NFV
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 and Methadone (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
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For over-the-counter use. A lay user study was performed at three intended user sites with 300 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Precision study:
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 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.
Interference study:
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device.
To demonstrate that there are no interference from each of the nine drug analytes on the other eight drug strips, devices in both CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup were tested using standard drug urine solutions at three fold cut-off drug concentrations of each drug analyte.
Specificity study:
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.
Effect of Urine Specific Gravity and Urine pH study:
Urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device.
Comparison Studies:
80 unaltered clinical samples for each drug (40 negative and 40 positive). The samples were blind labeled and compared to GC/MS results.
Lay-user study:
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The data for Secobarbital, Methadone and Oxycodone are reported, while data for other drugs were reported previously (K153741 and K161251). The results show a clear discrimination between negative and positive samples around the cutoff concentrations for both dip card and easy cup devices. For example, for Secobarbital Dip Card, at 286 ng/mL (cutoff), the detection rates were between 22-27 positive out of 50 samples, while at 370 ng/mL (+25% cutoff) all 50 samples were positive and at 226 ng/mL (-25% cutoff) all 50 samples were negative.
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: Compounds such as Acetominophen, Aspartame, Bilirubin, Hemoglobin, Uric acid and many others showed no interference at a concentration of 100ug/mL. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup. Tests also confirmed no interference between the nine drug analytes on other drug strips.
e. Specificity: Cross-reactivity was tested for drug metabolites and structurally related compounds. For Secobarbital (Cut-off=300 ng/mL), compounds like Amobarbital (100%), Phenobarbital (300%) showed high cross-reactivity, while Butalbital showed 12% at 2500 ng/mL. For Methadone (Cut-off=300 ng/mL), compounds like Doxylamine showed 6% cross-reactivity, while LAAM HCl, Alpha Methadol, EDDP, and EMDP showed less than 0.3% at >100000 ng/mL. For Oxycodone (Cut-off=100 ng/mL), Hydrocodone and Oxymorphone showed 6.4% cross-reactivity at 1562 ng/mL, while Codeine and Ethylmorphine showed much lower percentages. No differences were observed between the Dip Card and Easy Cup.
f. Effect of Urine Specific Gravity and Urine pH: Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off, across the tested specific gravity (1.000 to 1.035) and pH (4 to 9) ranges. No differences were observed between the Dip Card and Easy Cup.
2. Comparison Studies
Method comparison studies for both devices 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 GC/MS results.
For Secobarbital, Methadone, and Oxycodone, detailed results are provided. For example, for Secobarbital Dip Card, Viewer A detected 19 positive and 1 negative in the near cutoff positive range and 1 positive and 14 negative in the near cutoff negative range for a total of 40 positive and 40 negative samples. Discordant results are individually listed showing instances where the device result did not match the GC/MS result, particularly near the cutoff concentration. Similar tables and discordant results are presented for the Easy Cup device for each drug. Other data for Amphetamine, Oxazepam, Cocaine, Methamphetamine, Morphine and Marijuana were reported in K153741 and K161251.
Lay-user study
A lay user study was performed at three intended user sites with 300 lay persons for each device format. The study analyzed the percentage of correct results for various drugs (AMP, BAR, COC, BZO, MET, MTD, MOP, OXY, THC) at different concentrations relative to the cutoff (-100% to +75% cutoff).
The minimum percentage of correct results at -25% cut-off was 90% (e.g., MOP for Dip Card) and at +25% cut-off was 90% (e.g., BAR for Dip Card, AMP for Easy Cup). For concentrations further from the cutoff, the accuracy was generally 100%.
All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis on the package insert revealed a reading Grade Level of 7.
3. Clinical Studies
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics for precision show that for samples at or -25% below the cut-off, all samples tested negative. For samples at or +25% above the cut-off, all samples tested positive. At the cut-off concentration, the percentage of positive results varied, for example, for Secobarbital Dip Card, Lot 1 showed 28+/22- (56% positive), Lot 2 showed 24+/26- (48% positive), and Lot 3 showed 23+/27- (46% positive) out of 50 samples. Similar results were found for Methadone and Oxycodone.
In the Lay-user study, the percentage of correct results was calculated for each drug and concentration. For instance, at -25% Cut-off, AMP had 95% correct results (1 positive out of 20 samples was incorrect), while BAR had 100% correct results. At +25% Cut-off, AMP had 95% correct results (1 negative out of 20 samples was incorrect), while OXY had 100% correct results.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written in a sans-serif font.
February 28, 2018
Hangzhou Clongene Biotech Co.,Ltd. % Jesse Xia Manager LSI International 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K180255
Trade/Device Name: CLUNGENE Multi-Drug Test Dip Card CLUNGENE Multi-Drug Test Easy Cup Regulation Number: 21 CFR 862.3150 Regulation Name: Barbiturate Test System Regulatory Class: Class II Product Code: PTH, PTG, NGL, NGG, NFT, NFW, NFY, NFV Dated: January 25, 2018 Received: January 30, 2018
Dear Jesse Xia:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) K180255
Device Name
CLUNGENE® Multi-Drug Test Dip Card CLUNGENE® Multi-Drug Test Easy Cup
Indications for Use (Describe)
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
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 Oxazepam. Secobarbital 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 is the preferred confirmatory method. For in vitro diagnostic use only.
CLUNGENE® Multi-Drug Test Easy Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Oxazepam, Marijuana, Methamphetamine, Morphine, Oxycodone. Secobarbital and Methadone in human urine at the cutoff concentrations of:
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
| Oxazepam | Oxazepam | 300 ng/mL |
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-△9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
3
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 Oxazepam. Secobarbital 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 alternical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. For in vitro diagnostic use only.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) SUMMARY K180255
-
- Date: February 28, 2018
- Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China
-
- Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: 86 571 88262120 Email: frank@clongene.com.
-
- Device Name: CLUNGENE Multi-Drug Test Dip Card
CLUNGENE Multi-Drug Test Easy Cup
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NFT | |||
| Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| NFW | |||
| Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY | |||
| Cocaine | II | 21 CFR § 862.3250, Cocaine Test System | Toxicology (91) |
| NGG | |||
| Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGL | |||
| Morphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NFV | |||
| Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| NGL | |||
| Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| PTH | |||
| Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| PTG | |||
| Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
-
- 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, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of:
- Intended Use
| Drug(Identifier) | Calibrator | Cut-off level |
|---|---|---|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
5
| Oxazepam | Oxazepam | 300 ng/mL |
|---|---|---|
| Cocaine | Benzoylecgonine | 300 ng/mL |
| Marijuana | 11-Nor-Δ⁹-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
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 Oxazepam, Secobarbital 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, Morphine, Oxycodone, Secobarbital and Methadone 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-Δ9-Tetrahydrocannabinol-9-COOH | 50 ng/mL |
| Methamphetamine | d-Methamphetamine | 1000 ng/mL |
| Morphine | Morphine | 300 ng/mL |
| Oxycodone | Oxycodone | 100 ng/mL |
| Secobarbital | Secobarbital | 300 ng/mL |
| Methadone | Methadone | 300 ng/mL |
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 Oxazepam, Secobarbital 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
- Device Description
6
Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone (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.
-
- 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 | |||
| D J . L T 1 1001 | |||
| Item | Device | Predicate - K142396 | |
| 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 | 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 - K142396 |
|---|---|---|
| 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-Δ9-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 | 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 | 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 and Methadone in urine samples. The tests are lateral flow chromatographic immunoassays. During testing, a urine specimen migrates upward by capillary action. If target drugs present in the urine specimen are below the cut-off concentration, it will not saturate the binding sites of its specific monoclonal mouse antibody coated on the particles. The antibody-coated particles will then be captured by immobilized drug-conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the target drug level exceeds its 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
8
following tables for Secobarbital, Methadone and Oxycodone. The data for Methamphetamine, Morphine and Marijuana were reported in K153741; and the data for Amphetamine, Oxazepam and Cocaine were reported in K161251.
| 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 | 69 | 147 | 226 | 286 | 370 | 457 | 510 | 559 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 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- |
Secobarbital CLUNGENE Multi-Drug Test Dip Card
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 | 69 | 147 | 226 | 286 | 370 | 457 | 510 | 559 |
| 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+ | 21-/29+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Methadone 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 | 76 | 140 | 235 | 297 | 377 | 431 | 507 | 631 |
| 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+ | 29-/21+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
CLUNGENE Multi-Drug Test Easy Cup
| 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 | 76 | 140 | 235 | 297 | 377 | 431 | 507 | 631 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 27-/23+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Oxycodone
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 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 23-/27+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
9
| 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 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 24-/26+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| 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 | 25 | 48 | 72 | 101 | 119 | 142 | 164 | 187 |
| Lot 1 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 20-/30+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 28-/22+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ | 22-/28+ | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
The following cut-off values are verified.
| Drug(Identifier) | Cut-off level |
|---|---|
| Secobarbital (BAR) | 300 ng/mL |
| Methadone (MTD ) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
-
b. Linearity
Not applicable. -
c. Stability
The devices are stable at 4-30 ℃ for 24 months based on the accelerated stability study at 45 °C. Real time stability studies are ongoing. -
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drugs urine with concentrations at 25% below and 25% above Cut-Off levels. These urine samples were tested using three lots of each device. Compounds that showed no interference at a concentration of 100ug/mL are summarized in the following tables. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Acetominophen (4-
| Acetamidophenol) | Ecgonine methyl ester | D,L-Octopamine |
|---|---|---|
| Acetophenetidin | EMDP | Oxalic acid |
| N-Acetylprocainamide | Erythromycin | Oxolinic acid |
| Acetylsalicylic acid | β-Estradiol | Oxymetazoline |
| Albumin | Fenoprofen | Papaverine |
| Aminopyrine | Furosemide | Penicillin-G |
| Amoxicillin | Gentisic acid | Perphenazine |
| Ampicillin | Hemoglobin | Phenelzine |
| Apomorphine | Hydralazine | Prednisone |
| Ascorbic acid | Hydrochlorothiazide | DL-Propranolol |
10
| Aspartame | Hydrocortisone | D-Pseudoephedrine |
|---|---|---|
| Atropine | O-Hydroxyhippuric acid | Quinine |
| Benzilic acid | 3-Hydroxytyramine | Ranitidine |
| Benzoic acid | Ibuprofen | Salicylic acid |
| Bilirubin | D,L-Isoproterenol | Serotonin (5- Hydroxytyramine) |
| Chloralhydrate | Isoxsuprine | Sulfamethazine |
| Chloramphenicol | Ketamine | Sulindac |
| Chlorothiazide | Ketoprofen | Tetrahydrocortisone, 3-acetate |
| Chlorpromazine | Labetalol | Tetrahydrocortisone 3-(β- |
| Cholesterol | Loperamide | Dglucuronide) |
| Clonidine | Maprotiline | Tetrahydrozoline |
| Cortisone | Meperidine | Thiamine |
| (-) Cotinine | Meprobamate | Thioridazine |
| Creatinine | Methoxyphenamine | Triamterene |
| Deoxycorticosterone | Nalidixic acid | DL-Tyrosine |
| Dextromethorphan | Naloxone | Trifluoperazine |
| Diclofenac | Naltrexone | Trimethoprim |
| Diflunisal | Naproxen | D L-Tryptophan |
| Digoxin | Niacinamide | Tyramine |
| Diphenhydramine | Nifedipine | Uric acid |
| Disopyramide | Norethindrone | Verapamil |
| EDDP | Noscapine | Zomepirac |
To demonstrate that there are no interference from each of the nine drug analytes on the other eight drug strips, devices in both CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup were tested using standard drug urine solutions at three fold cut-off drug concentrations of each drug analyte. Tests showed positive result only for each target drug and negative result for other drugs.
e. Specificity
To test specificity, drug metabolites and other structurally related compounds that are likely to cross-react in urine samples were spiked into negative urine and were tested using three lots of each device. The lowest concentration that caused a positive result for each compound are listed below for Secobarbital, Methadone and Oxycodone. The data for Methamphetamine, Morphine and Marijuana were reported in K153741; and the data for Amphetamine, Oxazepam and Cocaine were reported in K161251. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
| Secobarbital | Result | % Cross-Reactivity |
|---|---|---|
| (Cut-off=300 ng/mL) | Positive at (ng/mL) | |
| Secobarbital | 300 | 100% |
| Amobarbital | 300 | 100% |
| Alphenol | 150 | 200% |
| Aprobarbital | 200 | 150% |
| Butabarbital | 75 | 400% |
| Butathal | 100 | 300% |
| Butalbital | 2500 | 12% |
| Cyclopentobarbital | 600 | 50% |
| Pentobarbital | 300 | 100% |
| Phenobarbital | 100 | 300% |
| Methadone
(Cut-off=300 ng/mL) | Result
Positive at(ng/ml) | % Cross-Reactivity |
| ---------------------------------- | ------------------------------ | -------------------- |
|---|
11
| Methadone | 300 | 100% |
|---|---|---|
| Doxylamine | 5000 | 6% |
| LAAM HCl | >100000 | 100000 |
| Drugs | % of Cut-off | Number
of
samples | Concentration by
LC/MS
(ng/mL) | Lay person results
No. of
Positive | Lay person results
No. of
Negative | The
percentage
of correct
results
(%) |
|--------------|---------------|-------------------------|--------------------------------------|------------------------------------------|------------------------------------------|---------------------------------------------------|
| AMP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 250 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 500 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 750 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 1250 | 19 | 1 | 95 |
| | +50% Cut-off | 40 | 1500 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 1750 | 20 | 0 | 100 |
| BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 375 | 18 | 2 | 90 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| COC | -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 | 160 | 150 | 0 | 160 | 100 |
| BZO | -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 | 250 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 500 | 0 | 160 | 100 |
| MET | -25% Cut-off | 20 | 750 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 1250 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 1500 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 1750 | 20 | 0 | 100 |
| | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| MTD | -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 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| MOP | -25% Cut-off | 20 | 225 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 375 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| OXY | -75% Cut-off | 20 | 25 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 50 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 75 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 125 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 150 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 175 | 20 | 0 | 100 |
| | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 12.5 | 0 | 20 | 100 |
| THC | -50% Cut-off | 160 | 25 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 37.5 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 62.5 | 18 | 2 | 90 |
| | +50% Cut-off | 40 | 75 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 87.5 | 20 | 0 | 100 |
| Drugs | % of Cut-off | Number
of
samples | Concentration by
LC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
| AMP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 250 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 500 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 750 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 1250 | 18 | 2 | 90 |
| | +50% Cut-off | 40 | 1500 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 1750 | 20 | 0 | 100 |
| BAR | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 375 | 18 | 2 | 90 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| COC | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 375 | 19 | 1 | 95 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| BZO | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 375 | 19 | 1 | 95 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| MET | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 250 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 500 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 750 | 2 | 18 | 90 |
| | +25% Cut-off | 20 | 1250 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 1500 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 1750 | 20 | 0 | 100 |
| MTD | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 0 | 20 | 100 |
| | +25% Cut-off | 20 | 375 | 19 | 1 | 95 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| MOP | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 75 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 150 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 225 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 375 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 450 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 525 | 20 | 0 | 100 |
| OXY | -100% Cut-off | 20 | 0 | 0 | 20 | 100 |
| | -75% Cut-off | 20 | 25 | 0 | 20 | 100 |
| | -50% Cut-off | 160 | 50 | 0 | 160 | 100 |
| | -25% Cut-off | 20 | 75 | 1 | 19 | 95 |
| | +25% Cut-off | 20 | 125 | 20 | 0 | 100 |
| | +50% Cut-off | 40 | 150 | 40 | 0 | 100 |
| | +75% Cut-off | 20 | 175 | 20 | 0 | 100 |
| | THC | -100% Cut-off | 20 | 0 | 0 | 20 |
| -75% Cut-off | | 20 | 12.5 | 0 | 20 | 100 |
| -50% Cut-off | | 160 | 25 | 0 | 160 | 100 |
| -25% Cut-off | | 20 | 37.5 | 0 | 20 | 100 |
| +25% Cut-off | | 20 | 62.5 | 19 | 1 | 95 |
| +50% Cut-off | | 40 | 75 | 40 | 0 | 100 |
| +75% Cut-off | | 20 | 87.5 | 20 | 0 | 100 |
CLUNGENE Multi-Drug Test Dip Card
15
CLUNGENE Multi-Drug Test Easy Cup
16
17
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
3. Clinical Studies
Not applicable.
11. Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison, and lay-user studies of the devices, it's concluded that the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are substantially equivalent to the predicate.