CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup
Device Facts
| Record ID | K180255 |
|---|---|
| Device Name | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup |
| Applicant | Hangzhou Clongene Biotech Co., Ltd. |
| Product Code | PTH · Clinical Toxicology |
| Decision Date | Feb 28, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.3150 |
| Device Class | Class 2 |
Intended Use
CLUNGENE® Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Ampletamine, Oxazepam, Methamphetamine, Morphine, Oxycodone, Secobarbital and Methadone in human urine at the cutoff concentrations of: [Table of drugs/cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs 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: [Table of drugs/cutoffs]. Configuration of the CLUNGENE® Multi-Drug Test Easy Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs 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.
Device Story
Lateral flow immunochromatographic assay for qualitative detection of drugs of abuse in human urine. Input: urine sample. Principle: competitive binding; target drugs in urine compete with drug-conjugate for limited antibody binding sites on particles. Output: visual colored lines on test strip; presence of line indicates drug concentration below cutoff; absence of line indicates concentration above cutoff. Used in home or clinical settings by lay users or professionals. Provides preliminary results; requires confirmation by GC/MS or LC/MS. Benefits: rapid, point-of-care screening for drug presence.
Clinical Evidence
No clinical studies performed. Evidence consists of analytical bench testing (precision, interference, specificity, cross-reactivity, stability) and a lay-user study (n=300 per device format) comparing results to GC/MS. Lay-user study demonstrated high concordance with GC/MS across various drug concentrations relative to cutoffs.
Technological Characteristics
Lateral flow immunochromatographic assay. Single-use device. Components: Dip Card or Easy Cup, urine collection cup, desiccant, aluminum pouch. Principle: competitive binding using monoclonal mouse antibodies. Qualitative visual readout. No electronic components or software.
Indications for Use
Indicated for qualitative, simultaneous detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, and Methadone in human urine. Intended for over-the-counter use. Not intended to distinguish between prescription use and abuse.
Regulatory Classification
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.
Special Controls
*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).
Related Devices
- K171695 — First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana · W.H.P.M., Inc. · Feb 5, 2018
- K190412 — CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup · Hangzhou Clongene Biotech Co., Ltd. · Mar 21, 2019
- K151642 — Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card · Healgen Scientific,, LLC · Aug 13, 2015
- K233019 — AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx · Hangzhou AllTest Biotech Co., Ltd. · Dec 13, 2023
Submission Summary (Full Text)
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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
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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
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## 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 |
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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)
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## 510(k) SUMMARY k180255
- 1. Date: February 28, 2018
- Hangzhou Clongene Biotech Co., Ltd. 2. Submitter: 20 Longquan Road Hangzhou 311121, China
- 3. Contact person: Zheng Shujian Hangzhou Clongene Biotech Co., Ltd. 20 Longquan Road Hangzhou 311121, China Telephone: 86 571 88262120 Email: frank@clongene.com.
- 4. Device Name: CLUNGENE Multi-Drug Test Dip Card
CLUNGENE Multi-Drug Test Easy Cup
| Classification: | Class 2 | | |
|------------------------|----------------|------------------------------------------------|-----------------|
| Product Code | Classification | Regulation Section | Panel |
| NFT<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| NFW<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| NFY<br>Cocaine | II | 21 CFR § 862.3250, Cocaine Test System | Toxicology (91) |
| NGG<br>Methamphetamine | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| NGL<br>Morphine | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| NFV<br>Oxazepam | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| NGL<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test System | Toxicology (91) |
| PTH<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| PTG<br>Methadone | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
## 5. Predicate Devices: K142396
The Chemtrue® Multi-Panel Drug Screen Dip Card Tests
- 6. 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:
| Drug(Identifier) | Calibrator | Cut-off level |
|------------------|---------------|---------------|
| Amphetamine | d-Amphetamine | 1000 ng/mL |
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| 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.
- 7. Device Description
The CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of
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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.
- 8. Substantial Equivalence Information A summary comparison of features of the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup and the predicate devices is provided in following tables.
| | 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)<br>for Use | For the qualitative determination of drugs of<br>abuse in human urine. | Same (but the number of<br>drugs detected is different) | |
| Calibrator and<br>Cut-Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>11-Nor-△9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml | Same | |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody<br>immunochemistry. | Same | |
| Type of Test | Qualitative | Same | |
| Specimen Type | Human Urine | Same | |
| Intended Use | For over-the-counter | Same | |
| Configurations | Dip Card | Same | |
Table 2: Features Comparison of CLUNGENE Multi-Drug Test Easy Cup Tests and the Predicate Devices
| Item | Device | Predicate - K142396 |
|--------------------------|------------------------------------------------------------------------|---------------------------------------------------------|
| Indication(s)<br>for Use | For the qualitative determination of<br>drugs of abuse in human urine. | Same (but the number of<br>drugs detected is different) |
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| Calibrator and Cut-Off<br>Values | Amphetamine (AMP): 1,000 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>11-Nor-Δ9-Tetrahydrocannabinol-9-COOH<br>(THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Morphine (MOR): 300ng/mL<br>Oxycodone(OXY) : 100 ng/ml<br>Secobarbital (BAR): 300 ng/ml<br>Methadone (MTD): 300 ng/ml | Same |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on<br>the principle of antigen antibody<br>immunochemistry. | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For over-the-counter | Same |
| Configurations | Cup | Dip Card |
## 9. Test Principle
The CLUNGENE Multi-Drug Test Dip Card, and CLUNGENE Multi-Drug Test Easy Cup are 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
- 1. Analytical Performance
### a. Precision
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off , +75% cut off and +100% cut off. These samples were prepared by spiking drug in negative urine samples. Each drug concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the sample testing. For each concentration, tests were performed two runs per day for 25 days per device in a randomized order. The results obtained are summarized in the
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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<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 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<br>LC/ MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | Cut-off<br>+25% | Cut-off<br>+50% | Cut-off<br>+75% | Cut-off<br>+100% |
|------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 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<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 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<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot | | | | | | | | | |
| 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<br>LC/MS (ng/mL) | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|-----------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| Lot<br>Number | 0 | 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- |
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| Concentration by<br>LC/MS (ng/mL)<br>Lot | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
|------------------------------------------|------------------|-----------------|-----------------|-----------------|---------|-----------------|-----------------|-----------------|------------------|
| 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<br>LC/MS (ng/mL)<br>Lot | -100%<br>Cut-off | -75%<br>Cut-off | -50%<br>Cut-off | -25%<br>Cut-off | Cut-off | +25%<br>Cut-off | +50%<br>Cut-off | +75%<br>Cut-off | +100%<br>Cut-off |
| 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-<br>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<br>(Cut-off=300 ng/mL) | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
|----------------------------------|------------------------------|--------------------|
{11}------------------------------------------------
| Methadone | 300 | 100% |
|----------------|---------|-------|
| Doxylamine | 5000 | 6% |
| LAAM HCl | >100000 | <0.3% |
| Alpha Methadol | >100000 | <0.3% |
| EDDP | >100000 | <0.3% |
| EMDP | >100000 | <0.3% |
| Oxycodone<br>(Cut-off=100 ng/mL) | Result<br>Positive at(ng/ml) | % Cross-Reactivity |
|----------------------------------|------------------------------|--------------------|
| Oxycodone | 100 | 100% |
| Codeine | 50000 | 0.2% |
| Dihydrocodeine | 12500 | 0.8% |
| Ethylmorphine | 25000 | 0.4% |
| Hydrocodone | 1562 | 6.4% |
| Hydromorphone | 12500 | 0.8% |
| Oxymorphone | 1562 | 6.4% |
| Thebaine | 50000 | 0.2% |
f. Effect of Urine Specific Gravity and Urine pH
To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with target drugs at 25% below and 25% above Cut-Off levels. These samples were tested using three lots of each device. Results were all positive for samples at and above +25% Cut-Off and all negative for samples at and below -25% Cut-Off. There were no differences observed between the CLUNGENE Multi-Drug Test Dip Card and CLUNGENE Multi-Drug Test Easy Cup.
## 2. Comparison Studies
Method comparison studies for the CLUNGENE Multi-Drug Test Dip Card and the CLUNGENE Multi-Drug Test Easy Cup were performed in-house with three laboratory assistants for each device. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples for each drug. The samples were blind labeled and compared to GC/MS results. The results are presented in the tables 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.
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 0 | 20 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results
{12}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer A | BAR79 | 298 | Positive |
| Viewer C | BAR29 | 294 | Positive |
| Viewer A | BAR14 | 316 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low Negative by GC/MS<br>(less than -50%) | Near Cutoff Negative by GC/MS<br>(Between -50% and cutoff) | Near Cutoff Positive by GC/MS<br>(Between the cutoff and +50%) | High Positive by GC/MS<br>(greater than +50%) |
|--------------------------------------------|----------|----------|-------------------------------------------|------------------------------------------------------------|----------------------------------------------------------------|-----------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 2 | 18 | 20 |
| | Negative | 10 | 15 | 13 | 2 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 19 | 20 |
| | Negative | 10 | 15 | 14 | 1 | 0 |
## Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| | | | |
| Viewer A | BAR79 | 298 | Positive |
| Viewer B | BAR30 | 296 | Positive |
| Viewer B | BAR79 | 298 | Positive |
| Viewer C | BAR29 | 294 | Positive |
| Viewer A | BAR33 | 330 | Negative |
| Viewer B | BAR14 | 316 | Negative |
| Viewer B | BAR35 | 349 | Negative |
| Viewer C | BAR14 | 316 | Negative |
# Methadone
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 19 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 14 | 0 | 0 |
Discordant Results
{13}------------------------------------------------
| Viewer | Sample Number | GC/MS Result | Dip Card Viewer Results |
|----------|---------------|--------------|-------------------------|
| Viewer B | MTD28 | 297 | Positive |
| Viewer C | MTD14 | 292 | Positive |
| Viewer A | MTD29 | 308 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer | Positive | 0 | 0 | 2 | 19 | 20 |
| A | Negative | 10 | 15 | 13 | 1 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 20 | 20 |
| B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer | Positive | 0 | 0 | 1 | 19 | 20 |
| C | Negative | 10 | 15 | 14 | 1 | 0 |
## Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer A | MTD14 | 292 | Positive |
| Viewer A | MTD28 | 297 | Positive |
| Viewer B | MTD28 | 297 | Positive |
| Viewer C | MTD14 | 292 | Positive |
| Viewer A | MTD29 | 308 | Negative |
| Viewer C | MTD76 | 313 | Negative |
# Oxycodone
| CLUNGENE<br>Multi-Drug<br>Test Dip Card | | Negative | Low Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|-----------------------------------------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 20 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 15 | 0 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 19 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 14 | 1 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 19 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 15 | 1 | 0 |
# Discordant Results
| Viewer | Sample Number | GC/MS Result | Dip Card<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | OXY66 | 92 | Positive |
{14}------------------------------------------------
| Viewer B | OXY39 | 101 | Negative |
|----------|-------|-----|----------|
| Viewer C | OXY30 | 102 | Negative |
| CLUNGENE<br>Multi-Drug<br>Test Easy<br>Cup | | Negative | Low<br>Negative by<br>GC/MS<br>(less than<br>-50%) | Near Cutoff<br>Negative by<br>GC/MS<br>(Between<br>-50% and<br>cutoff) | Near Cutoff<br>Positive by<br>GC/MS<br>(Between the<br>cutoff and<br>+50%) | High Positive<br>by GC/MS<br>(greater than<br>+50%) |
|--------------------------------------------|----------|----------|----------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Viewer<br>A | Positive | 0 | 0 | 0 | 19 | 20 |
| Viewer<br>A | Negative | 10 | 15 | 15 | 1 | 0 |
| Viewer<br>B | Positive | 0 | 0 | 1 | 20 | 20 |
| Viewer<br>B | Negative | 10 | 15 | 14 | 0 | 0 |
| Viewer<br>C | Positive | 0 | 0 | 0 | 19 | 20 |
| Viewer<br>C | Negative | 10 | 15 | 15 | 1 | 0 |
## Discordant Results
| Viewer | Sample Number | GC/MS Result | Easy Cup<br>Viewer Results |
|----------|---------------|--------------|----------------------------|
| Viewer B | OXY66 | 92 | Positive |
| Viewer A | OXY39 | 101 | Negative |
| Viewer C | OXY30 | 102 | Negative |
Lay-user study
A lay user study was performed at three intended user sites with 300 lay persons for each device format. The lay users had diverse educational and professional backgrounds and ranged in age from 18 to > 50 years. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with the package insert, 1 blind labeled sample and a device. Each device was tested. Results are shown below.
| Drugs | % of Cut-off | Number<br>of<br>samples | Concentration by<br>LC/MS<br>(ng/mL) | Lay person results<br>No. of<br>Positive | Lay person results<br>No. of<br>Negative | The<br>percentage<br>of correct<br>results<br>(%) |
|--------------|---------------|-------------------------|--------------------------------------|------------------------------------------|------------------------------------------|---------------------------------------------------|
| 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<br>of<br>samples | Concentration by<br>LC/MS<br>(ng/mL) | Lay person results | | The<br>percentage of<br>correct results<br>(%) |
| 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…
