(57 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay lateral flow test, with no mention of AI or ML for interpretation or analysis.
No
The device is an immunoassay for the qualitative determination of drugs in human urine, providing preliminary results for diagnostic purposes, not for treatment.
Yes
The text explicitly states "For in vitro diagnostic use only" in the "Intended Use / Indications for Use" section and also mentions that the products are "single-use in vitro diagnostic devices" under "Device Description".
No
The device is described as an "immunochromatographic assay that use a lateral flow system" and a "dipcard format in which the test strips are integrated into the plastic dipcard." This clearly indicates a physical, hardware-based device for in vitro diagnostic testing, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the Rx and OTC versions clearly states: "For in vitro diagnostic use only."
- Device Description: The "Device Description" section also explicitly states: "The products are single-use in vitro diagnostic devices."
- Nature of the Test: The device performs a qualitative determination of drugs in human urine, which is a biological sample. This type of testing performed on samples taken from the body is the definition of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 ng/mL
Methadone (MTD) 300 ng/mL
Oxycodone (OXY) 100 ng/mL
Phencyclidine (PCP) 25 ng/mL
Propoxyphene (PPX) 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Amphetamine (AMP) 1000 or 500 ng/mL
Secobarbital (BAR) 300 ng/mL
Buprenorphine (BUP) 10 ng/mL
Oxazepam (BZO) 300 ng/mL
Cocaine (COC) 300 or 150 ng/mL
2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) 300 ng/mL
Methylenedioxymethamphetamine (MDMA) 500 ng/mL
Methamphetamine (MET) 1000 or 500 ng/mL
Morphine (MOP/OPI) 300 or 2000 ng/mL
Methadone (MTD) 300 ng/mL
Oxycodone (OXY) 100 ng/mL
Phencyclidine (PCP) 25 ng/mL
Propoxyphene (PPX) 300 ng/mL
Nortriptyline (TCA) 1000 ng/mL
Cannabinoids (THC) 50 ng/mL
6-Monoacetylmorphine (6-MAM) 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
DJG, NFT, DKZ, PTH, DIS, NGL, NFV, JXM, NFY, DIO, PTG, DJR, NGG, DJC, NGM, LCM, QBF, JXN, QAW, LFG, NFW, LDJ
Device Description
Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are singleuse in vitro diagnostic devices.
This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use, Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical Performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff,-25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test dipcard. (Results are summarized in tables in the original document, showing number of negative and positive results at each concentration for each drug and lot.)
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device can be stable at 2-30°C for 36 months based on real time stability study.
d. Detection limit:
Not applicable.
e. Analytical specificity/Interference:
Cross-Reactivity:
Analytical specificity was determined by adding potential interfering substances to drug-free urine samples. The relative cross-reactivity was calculated as the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. Percent cross-reactivity was provided in tables for various compounds relative to each drug.
Interfering Substances:
Non-structurally related compounds were added to drug-free urine and to urine samples containing target drugs at 25% below and 25% above each corresponding cutoff to evaluate potential interference. Compounds showed no interference at a concentration of 100 μg/mL are listed.
Effect of Urinary pH and Specific Gravity:
Interference by urinary pH and specific gravity was evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 25% below and 25% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
B. Method Comparison Study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results. (Detailed tables of results for each drug test by three viewers, showing results against LC-MS/MS confirmed drug-free, low negative, near cutoff negative, near cutoff positive, and high positive samples. Discordant results are also summarized in a table.)
C. Lay Person Study
79 male and 61 female tested Dochek® Multi-Drug Urine Test Dipcard Configuration 1; 73 male and 67 female tested Dochek® Multi-Drug Urine Test Dipcard Configuration 2. They had diverse educational and occupational backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations: -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/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. The results are summarized in tables showing negative, positive, total, and percentage of correct results for each drug at different drug concentrations.
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
D. Clinical Studies
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Key metrics are presented in tables in the "Summary of Performance Studies" section under "B. Method Comparison Study" and "C. Lay Person Study" based on the number of agreements between the test device results and LC-MS/MS results or expected results, given as counts of positive/negative readings at specified cutoff percentages. Percentage of correct results is given for the Lay Person Study.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Guangzhou Decheng Biotechnology Co., Ltd. Mango Huang Regulatory Affairs Manager Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road Science City, Huangpu District Guangzhou, 510663 China
Re: K240698
Trade/Device Name: Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, NFT, DKZ, PTH, DIS, NGL, NFV, JXM, NFY, DIO, PTG, DJR, NGG, DJC, NGM, LCM, QBF, JXN, QAW, LFG, NFW, LDJ Dated: March 14, 2024 Received: March 14, 2024
Dear Mango Huang:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A. Digitally signed by Joseph A. Kotarek - Kotarek - S Date: 2024.05.09 S 14:56:49 -04'00'
Joseph Kotarek Branch Chief
2
Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240698
Device Name
Dochek® Multi-Drug Urine Test Dipcard Rx
Indications for Use (Describe)
Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
| Drug (Identifier) |
|---|
| Amphetamine (AMP) |
| Secobarbital (BAR) |
| Buprenorphine (BUP) |
| Oxazepam (BZO) |
| Cocaine (COC) |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) |
| Methylenedioxymethamphetamine (MDMA) |
| Methamphetamine (MET) |
| Morphine (MOP/OPI) |
| Methadone (MTD) |
| Oxycodone (OXY) |
| Phencyclidine (PCP) |
| Propoxyphene (PPX) |
| Nortriptyline (TCA) |
| Cannabinoids (THC) |
| 6-Monoacetylmorphine (6-MAM) |
Cut-off level 1000 or 500 ng/mL 300 ng/mL 10 ng/mL 300 ng/mL 300 or 150 ng/mL 300 ng/mL 500 ng/mL 1000 or 500 ng/mL 300 or 2000 ng/mL 300 ng/mL 100 ng/mL 25 ng/mL 300 ng/mL 1000 ng/mL 50 ng/mL 10 ng/mL
Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS is the recommended confirmatory method.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
4
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."
5
Indications for Use
510(k) Number (if known) K240698
Device Name
Dochek® Multi-Drug Urine Test Dipcard
Indications for Use (Describe)
Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
Cut-off level 1000 or 500 ng/mL
300 ng/mL 10 ng/mL 300 ng/mL
300 ng/mL 100 ng/mL 25 ng/mL 300 ng/mL 1000 ng/mL 50 ng/mL 10 ng/mL
300 or 150 ng/mL 300 ng/mL 500 ng/mL
1000 or 500 ng/mL 300 or 2000 ng/mL
| Drug (Identifier) |
|---|
| Amphetamine (AMP) |
| Secobarbital (BAR) |
| Buprenorphine (BUP) |
| Oxazepam (BZO) |
| Cocaine (COC) |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) |
| Methylenedioxymethamphetamine (MDMA) |
| Methamphetamine (MET) |
| Morphine (MOP/OPI) |
| Methadone (MTD) |
| Oxycodone (OXY) |
| Phencyclidine (PCP) |
| Propoxyphene (PPX) |
| Nortriptyline (TCA) |
| Cannabinoids (THC) |
| 6-Monoacetylmorphine (6-MAM) |
Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
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.
6
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."
7
510(k) SUMMARY
510(k) number: K240698
- Date: May 9, 2024 1. Submitter: Submitter: Guangzhou Decheng Biotechnology Co., Ltd. 2. Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District, Guangzhou, Guangdong, 510663, P.R. China Contact Person: Mango Huang Contact Email Address: mango.huang(@)dochekbio.com Telephone: +86-020-82557192 Correspondent: Correspondent: Guangzhou Decheng Biotechnology Co., Ltd. 3. Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City, Huangpu District, Guangzhou, Guangdong, 510663, P.R. China Contact Person: Mango Huang Contact Email Address: mango.huang(@dochekbio.com Telephone: (888) 695-5248 4. Device Name: Dochek® Multi-Drug Urine Test Dipcard Rx Dochek® Multi-Drug Urine Test Dipcard
5. Classification: Class II
| Product Code | Regulation Section | Panel |
|---|---|---|
| Target Drug | ||
| DKZ, NFT | ||
| Amphetamine (AMP) | 862.3100, Amphetamine Test System | Toxicology |
| DIS, PTH | ||
| Secobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| DJG, NGL | ||
| Buprenorphine (BUP) | ||
| Morphine (MOP/OPI) | ||
| Oxycodone (OXY) | ||
| 6-Monoacetylmorphine (6-MAM) | 862.3650, Opiate Test System | Toxicology |
| JXM, NFV | ||
| Oxazepam (BZO) | 862.3170, Benzodiazepine Test System | Toxicology |
| DIO, NFY | ||
| Cocaine (COC) | 862.3250, Cocaine and cocaine | |
| metabolite test system | Toxicology | |
| DJR, PTG | ||
| 2-ethylidene-1,5-dimethyl-3,3- | ||
| diphenylpyrrolidine (EDDP) | ||
| Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
8
| DJC, NGG
Methylenedioxymethamphetamine
(MDMA)
Methamphetamine (MET) | 862.3610,
Methamphetamine Test System | Toxicology |
|------------------------------------------------------------------------------|--------------------------------------------------------|------------|
| LCM, NGM
Phencyclidine (PCP) | Unclassified | Toxicology |
| JXN, QBF
Propoxyphene (PPX) | 862.3700 Propoxyphene test system. | Toxicology |
| LFG, QAW
Nortriptyline (TCA) | 862.3910 Tricyclic antidepressant
drugs test system | Toxicology |
| LDJ, NFW
Cannabinoids (THC) | 862.3870, Cannabinoids Test System | Toxicology |
Predicate Devices 6.
| K232659 | Dochek® Multi-Drug Urine Test Cup Rx |
|---|---|
| K232659 | Dochek® Multi-Drug Urine Test Cup |
7. Intended Use
Dochek® Multi-Drug Urine Test Dipcard Rx is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 or 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 1000 or 500 ng/mL |
| Morphine (MOP/OPI) | 300 or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
Dochek® Multi-Drug Urine Test Dipcard Rx offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device. It is intended for prescription use. For in vitro diagnostic use only.
9
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Dochek® Multi-Drug Urine Test Dipcard is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine (AMP) | 1000 or 500 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 or 150 ng/mL |
| 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP) | 300 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Methamphetamine (MET) | 1000 or 500 ng/mL |
| Morphine (MOP/OPI) | 300 or 2000 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Propoxyphene (PPX) | 300 ng/mL |
| Nortriptyline (TCA) | 1000 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
Dochek® Multi-Drug Urine Test Dipcard offers any combinations from 1 to 16 drugs but only one cutoff concentration under same drug condition will be included per device.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. GC/MS or LC/MS is the recommended confirmatory method.
Device Description 8.
Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine at or above the cut-off levels as indicated. The products are singleuse in vitro diagnostic devices.
This device is a dipcard format in which the test strips are integrated into the plastic dipcard. After removing the cap of the dipcard, the absorbent end of the test strips is exposed and can be in direct
10
contact with the urine sample. The device is in a ready-to-use format and no longer requires assembly before use.
| Similarities | ||
|---|---|---|
| Item | New Device | Predicate Device |
| (K232659) | ||
| Intended use | Qualitative detection of drugs of abuse in urine. | |
| For prescription use or over-the-counter use | Same | |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assay based on antigen- | ||
| antibody reaction | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug | ||
| and Cutoff | ||
| Value | Target Drug | Cutoff |
| (ng/mL) | ||
| Amphetamine (AMP) | 1000 or 500 | |
| Secobarbital (BAR) | 300 | |
| Buprenorphine (BUP) | 10 | |
| Oxazepam (BZO) | 300 | |
| Cocaine (COC) | 300 or 150 | |
| 2-ethylidene-1,5-dimethyl-3,3- | ||
| diphenylpyrrolidine (EDDP) | 300 | |
| Methylenedioxymethamphetamine | ||
| (MDMA) | 500 | |
| Methamphetamine (MET) | 1000 or 500 | |
| Morphine (MOP300/OPI2000) | 2000 or 300 | |
| Methadone (MTD) | 300 | |
| Oxycodone (OXY) | 100 | |
| Phencyclidine (PCP) | 25 | |
| Propoxyphene (PPX) | 300 | |
| Nortriptyline (TCA) | 1000 | |
| Cannabinoids (THC) | 50 | |
| 6-Monoacetylmorphine (6-MAM) | 10 | |
| Differences | ||
| Configurations | Test dipcard | Test cup |
Substantial Equivalence Information 9.
10. Standard/Guidance Document Reference (if applicable)
None referenced.
11. Test Principle
Dochek® Multi-Drug Urine Test Dipcard Rx or Dochek® Multi-Drug Urine Test Dipcard is a
11
competitive immunoassay that is used to screen for the presence of various drugs and drug metabolites in urine. It is chromatographic absorbent device in which, drugs within a urine sample, competitively combined to a limited number of drug monoclonal antibody (mouse) conjugate binding sites.
When the test is activated, the urine is absorbed into each test strip by capillary action, mixes with the respective drug monoclonal antibody conjugate, and flows across a pre-coated membrane. When drug in the urine sample is below the detection level of the test, respective drug monoclonal antibody conjugate binds to the respective drug-protein conjugate immobilized in the Test Region (T) of the test strip. This produces a colored Test line in the Test Region (T) of the strip, which, regardless of its intensity, indicates a negative test result.
When drug level is at or above the detection level of the tree drug in the sample binds to the respective drug monoclonal antibody conjugate, preventing the respective drug monoclonal antibody conjugate from binding to the respective drug-protein conjugate immobilized in the Test Region (T) of the device. This prevents the development of a distinct colored band in the test region, indicating a preliminary positive result.
To serve as a procedure control, a colored line will appear at the Control Region (C) of each strip, if the test has been performed properly.
12. Performance Characteristics
A. Analytical Performance
a. Precision/Reproducibility:
Precision studies were carried out for samples with concentrations of +100% cutoff, +50% cutoff, +25% cutoff, cutoff, -25% cutoff, -50% cutoff, -75% cut off and -100% cutoff. Other samples were prepared by spiked target drug in drug-free urine samples. Each drug concentration was confirmed by LC-MS/MS. For each concentration, tests were performed two runs per day for 25 days using three lots of test dipcard. The results obtained are summarized in the following tables:
| Drug | Lot
Number | +100%
cutoff | +75%
cutoff | +50%
cutoff | +25%
cutoff | Cutoff | -25%
cutoff | -50%
cutoff | -75%
cutoff | -100%
cut-off |
|-------------|---------------|-----------------|----------------|----------------|----------------|---------|----------------|----------------|----------------|------------------|
| AMP
1000 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 1000 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BAR
300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BUP
10 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 16-/34+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 10 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| BZO
300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| EDDP | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MDM A 500 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET 1000 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OPI 2000 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 9-/41+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 10-/40+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MTD 300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| OXY 100 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PCP 25 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 16-/34+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| PPX 300 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| TCA 1000 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 11-/39+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| THC 50 | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 6-MAM | Lot I | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot II | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot III | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| AMP 500 | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| COC 150 | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MET | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 500 | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 13-/37+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 12-/38+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| MOP | Lot IV | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| 300 | Lot V | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 15-/35+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
| | Lot VI | 0-/50+ | 0-/50+ | 0-/50+ | 0-/50+ | 14-/36+ | 50-/0+ | 50-/0+ | 50-/0+ | 50-/0+ |
12
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b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device can be stable at 2-30°C for 36 months based on real time stability study.
d. Detection limit:
Not applicable.
e. Analytical specificity/Interference:
Cross-Reactivity:
Analytical specificity for this device was determined through adding the potential interfering substances to drug-free urine samples. The relative cross-reactivity represents the minimum concentration necessary to yield a result similar to the cutoff level of the respective assay. Percent cross-reactivity, provided in the below table, was calculated as the concentration of analyte tested that yielded a positive result, divided by the cutoff concentration, multiplied by 100. If no cross reactivity was observed, the highest concentration tested is shown.
| Drug/Cutoff | Compound | Concentration
(ng/mL) | % Cross-Reactivity |
|---------------------------------|---------------------------------------------------------|--------------------------|--------------------|
| AMP 1000 | d-Amphetamine | 1,000 | 100% |
| | d/l-Amphetamine | 3,000 | 33.3% |
| | l-Amphetamine | 50,000 | 2% |
| | (+/-) 3,4-
methylenedioxyamphetamine
(MDA) | 5,000 | 20% |
| | Phentermine | 3,000 | 33.3% |
| | Hydroxyamphetamine | 10,000 | 10% |
| | d-Methamphetamine | 100,000(Negative) | Not detected |
| | l-Methamphetamine | 100,000(Negative) | Not detected |
| | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | 100,000(Negative) | Not detected |
| | (+/-)3,4-
Methylenedioxymethamphetamine
(MDMA) | 100,000(Negative) | Not detected |
| | (1R,2S)-(-)-Ephedrine | 100,000(Negative) | Not detected |
| | β-Phenylethylamine | 100,000 | 1% |
| | Tyramine | 100,000 | 1% |
| | p-Hydroxynorephedrine | 100,000 | 1% |
| | Phenylpropanolamine | 100,000(Negative) | Not detected |
| | (±)Phenylpropanolamine | 100,000(Negative) | Not detected |
| | p-Hydroxyamphetamine | 100,000 | 1% |
| | d/l-Norephedrine | 100,000 | 1% |
| | Benzphetamine | 100,000(Negative) | Not detected |
| | 1-Epinephrine | 100,000(Negative) | Not detected |
| | d/l-Epinephrine | 100,000(Negative) | Not detected |
| | Secobarbital | 300 | 100% |
| | Amobarbital | 1,000 | 30% |
| | Alphenal | 75 | 400% |
| | Aprobarbital | 250 | 120% |
| BAR 300 | Butabarbital | 100 | 300% |
| | Butalbital | 5,000 | 6% |
| | Butethal | 500 | 60% |
| | Cyclopentobarbital | 500 | 60% |
| | Pentobarbital | 200 | 150% |
| | Phenobarbital | 300 | 100% |
| | Buprenorphine | 10 | 100% |
| | Norbuprenorphine | 50 | 20% |
| | Buprenorphine 3-D-glucuronide | 10 | 100% |
| BUP 10 | Norbuprenorphine 3-D-
glucuronide | 10 | 100% |
| | Morphine | 100000 (Negative) | Not Detected |
| | Oxymorphone | 100000 (Negative) | Not Detected |
| | Hydromorphone | 100000 (Negative) | Not Detected |
| | Oxazepam | 300 | 100% |
| | Alprazolam | 150 | 200% |
| | α-Hydroxyalprazolam | 1,500 | 20% |
| | Bromazepam | 100 | 300% |
| | Chlordiazepoxide | 500 | 60% |
| | Clobazam | 750 | 40% |
| | Clonazepam | 1,500 | 20% |
| | Clorazepate dipotassium | 100 | 300% |
| | Diazepam | 500 | 60% |
| | Estazolam | 500 | 60% |
| | Flunitrazepam | 2,500 | 12% |
| BZO 300 | Midazolam | 2,000 | 15% |
| | Nitrazepam | 2,000 | 15% |
| | Nordiazepam | 500 | 60% |
| | Temazepam | 250 | 120% |
| | Triazolam | 1,000 | 30% |
| | Desalkylflurazepam | 500 | 60% |
| | Lorazepam | 5,000 | 6% |
| | Norchlordiazepoxide | 500 | 60% |
| | Nordazepam | 1,000 | 30% |
| | Delorazepam | 2,000 | 15% |
| | Demoxepam | 5,000 | 6% |
| | Flurazepam | 500 | 60% |
| | Benzoylecgonine | 300 | 100% |
| | Cocaine HCl | 750 | 40% |
| | Cocaethylene | 12,500 | 2.4% |
| COC 300 | Ecgonine | 30,000 | 1% |
| | Ecgonine methyl ester | 100,000(negative) | Not detected |
| | Norcocaine | 100,000(negative) | Not detected |
| | 2-ethylidene-1,5-dimethyl-3,3- | 300 | 100% |
| | diphenylpyrrolidine | | |
| EDDP 300 | Methadone | 100,000(negative) | Not detected |
| | EMDP | 100,000(negative) | Not detected |
| | Doxylamine | 100,000(negative) | Not detected |
| | Levacetylmethadol (LAAM) | 100,000(negative) | Not detected |
| | Disopyramide | 100,000(negative) | Not detected |
| | Alpha Methadol | 100,000(negative) | Not detected |
| MDMA 500 | (+/-)3,4-
Methylenedioxymethamphetamine
HCI(MDMA) | 500 | 100% |
| | (+/-)3,4-
Methylenedioxyamphetamine HCl
(MDA) | 3,000 | 17% |
| | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | 300 | 167% |
| | d-Methamphetamine | 100,000(Negative) | Not detected |
| | d-Amphetamine | 100,000(Negative) | Not detected |
| | 1-Methamphetamine | 100,000(Negative) | Not detected |
| | 1-Amphetamine | 100,000(Negative) | Not detected |
| | d-Methamphetamine | 1,000 | 100% |
| | d-Amphetamine | 50,000 | 2% |
| | Chloroquine | 50,000 | 2% |
| | (1R,2S)-(-)-Ephedrine | 50,000 | 2% |
| | (-)-Methamphetamine | 25,000 | 4% |
| MET 1000 | (+/-)3,4-
methylenedioxumethamphetamine
(MDMA) | 4,000 | 25% |
| | β-Phenylethylamine | 50,000 | 2% |
| | Trimethobenzamide | 10,000 | 10% |
| | 1-Amphetamine | 75,000 | 1.3% |
| | (+/-)3,4-
Methylenedioxyethylamphetamine
(MDEA) | 30,000 | 3.3% |
| | Mephentermine | 50,000 | 2% |
| | Methoxyphenamine | 50,000 | 2% |
| | Fenfluramine | 75,000 | 1.3% |
| | Procaine | 100,000(Negative) | Not detected |
| | d/l-Amphetamine | 100,000(Negative) | Not detected |
| | p-Hydroxymethamphetamine | 30,000 | 3.3% |
| | l-Phenylephrine | 100,000(Negative) | Not detected |
| | d/l-Methamphetamine | 1,000 | 100% |
| | (+/-) 3,4-
Methylenedioxyamphetamine
(MDA) | 100,000(Negative) | Not detected |
| | Morphine | 2,000 | 100% |
| | Codeine | 2,000 | 100% |
| | Hydrocodone | 12,500 | 16% |
| | Hydromorphone | 5,000 | 40% |
| | 6-Monoacetylmorphine | 1,500 | 133% |
| | Morphine 3-β-D-glucuronide | 2,000 | 100% |
| | Ethylmorphine | 1,500 | 133% |
| | Diacetylmorphine (heroin) | 2,000 | 100% |
| OPI 2000 | Levorphanol | 75,000 | 2.7% |
| | Norcodeine | 12,500 | 16% |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Thebaine | 5,000 | 40% |
| | Normorphine | 50,000 | 4% |
| | Oxymorphone | 100,000(Negative) | Not detected |
| | Procaine | 100,000(Negative) | Not detected |
| | Codeine-6-β-D-glucuronide | 3,000 | 67% |
| | d-Norpropoxyphene hydrochloride | 5,000 | 40% |
| | Methadone | 300 | 100% |
| MTD 300 | EDDP | 100,000(Negative) | Not detected |
| | Doxylamine | 50,000 | 0.6% |
| | Levacetylmethadol (LAAM) | 100,000(negative) | Not detected |
| | EMDP | 100,000(negative) | Not detected |
| | Alpha Methadol | 100,000(negative) | Not detected |
| | Oxycodone | 100 | 100% |
| OXY 100 | Hydrocodone | 5,000 | 2% |
| | Hydromorphone | 50,000 | 0.2% |
| | Oxymorphone | 1,000 | 10% |
| | Codeine | >100,000 | Not detected |
| | Ethylmorphine | >100,000 | Not detected |
| | Dihydrocodeine | 20,000 | 0.5% |
| | Oxymorphone-3β-D- glucuronide | 5,000 | 2% |
| | Morphine | 100,000(negative) | Not detected |
| | 6-Monoacetylmorphine | 100,000(negative) | Not detected |
| | Buprenorphine | 100,000(negative) | Not detected |
| | Thebaine | 100,000(negative) | Not detected |
| | Phencyclidine | 25 | 100% |
| PCP 25 | 4-Hydroxy Phencyclidine | 1,500 | 1.7% |
| | d-Propoxyphene | 300 | 100% |
| PPX 300 | d-Norpropoxyphene | 300 | 100% |
| | Nortriptyline | 1,000 | 100% |
| | Nordoxepin | 1,000 | 100% |
| | Trimipramine | 3,000 | 33.3% |
| | Promazine | 1,500 | 66.7% |
| | Desipramine | 200 | 500% |
| | Imipramine | 750 | 133% |
| TCA 1000 | Clomipramine | 10,000 | 10% |
| | Doxepin | 1,250 | 80% |
| | Maprotiline | 2,000 | 50% |
| | Amitriptyline | 1,500 | 66.7% |
| | Promethazine | 25,000 | 4% |
| | Cyclobenzaprine | 1,000 | 100% |
| | Norclomipramine | 12,500 | 8% |
| | 11-nor-Δ9-THC-9-COOH | 50 | 100% |
| THC 50 | 11-nor-Δ8-THC-9-COOH | 30 | 167% |
| | (±)-11-Hydroxy-Δ9-THC | 2,500 | 2% |
| | Δ8- Tetrahydrocannabinol | 2,000 | 2.5% |
| | Δ9- Tetrahydrocannabinol | 5,000 | 1% |
| | Cannabinol | 10,000 | 0.5% |
| | Cannabidiol(CBD) | 100,000 | 0.05% |
| | (±)-11-nor-9-carboxy-Δ9-THC | 100 | 50% |
| | 11-nor-Δ9-THC-carboxy
glucuronide | | |
| 6-MAM | 6-Monoacetylmorphine | 10 | 100% |
| | Codeine | 100,000(Negative) | Not detected |
| | Ethylmorphine | 100,000(Negative) | Not detected |
| | Hydrocodone | 50,000 | 0.02% |
| | Hydromorphone | 10,000 | 0.1% |
| | Levorphanol | 100,000(Negative) | Not detected |
| | Morphine 3-β-D-glucuronide | 100,000(Negative) | Not detected |
| | Morphine | 100,000 | 0.01% |
| | Norcodeine | 100,000(Negative) | Not detected |
| | Normorphine | 100,000(Negative) | Not detected |
| | Oxycodone | 100,000(Negative) | Not detected |
| | Oxymorphone | 10,000 | 0.1% |
| | Procaine | 50,000 | 0.02% |
| | Thebaine | 10,000 | 0.1% |
| | Diacetylmorphine (heroin) | 25 | 40% |
| 10 | Acetylcodeine | 10,000(Negative) | 100,000 | Not detected |
| | d/l-Amphetamine | 75,000 | 0.7% |
| | p-Hydroxymethamphetamine | 15,000 | 3.3% |
| | l-Phenylephrine | >100,000 | Not detected |
| | d/l-Methamphetamine | 500 | 100% |
| | (+/-) 3,4-
Methylenedioxyamphetamine
(MDA) | 75,000 | 0.7% |
| MOP 300 | Morphine | 300 | 100% |
| | Codeine | 300 | 100% |
| | Hydrocodone | 5,000 | 6% |
| | Hydromorphone | 1,000 | 30% |
| 6-Monoacetylmorphine | 150 | 200% | |
| Morphine 3-β-D-glucuronide | 1,000 | 30% | |
| Ethylmorphine | 100 | 300% | |
| Diacetylmorphine (heroin) | 300 | 100% | |
| Levorphanol | 10,000 | 3% | |
| Norcodeine | 5,000 | 6% | |
| Oxycodone | 75,000 | 0.4% | |
| Thebaine | 3,000 | 10% | |
| Normorphine | 3,000 | 10% | |
| Oxymorphone | 25,000 | 1.2% | |
| Procaine | 100,000(Negative) | Not detected | |
| Codeine-6-β-D-glucuronide | 500 | 60% | |
| d-Norpropoxyphene hydrochloride | 300 | 100% | |
14
15
16
17
18
19
20
21
22
Interfering Substances:
To evaluate potential interference, non-structurally related compounds were added to drug-free urine and to urine samples containing the target drugs at 25% below and 25% above each corresponding cutoff. Compounds that show no interference at a concentration of 100μg/mL are summarized in the following table.
| 3-Hydroxytyramine | Diflunisal | Oxalic Acid |
|---|---|---|
| Acetaminophen | Digoxin | Oxolinic Acid |
| Acetylsalicylic Acid | Diphenhydramine | Oxymetazoline |
| Acyclovir | Dopamine HCl | Paliperidone |
| Albumin (100 mg/dL) | D-Pseudoephedrine | Papaverine |
| Albuterol sulfate (Proair HFA) | Duloxetine | Penicillin-G |
| Aminophylline | Erythromycin | PenicillinV Potassium |
| Aminopyrine | Esomeprazole Magnesium | Phenacetin (Acetophenetidin) |
| Amoxicillin | Ethanol (1%) | Phenelzine |
| Ampicillin | Fenoprofen | Prednisone |
| Apomorphine | Fluoxetine Hydrochloride | Pregablin |
| Aripiprazole | Furosemide | Quinine |
| Aspartame | Gabapentin | Ranitidine |
| Atomoxetine | Gentisic Acid | Rifampicin |
| Atorvastatin Calcium | Glucose | Risperidone |
| Atropine | Hemoglobin | Salicylic Acid |
| Azithromycin | Hydralazine | Serotonin |
| Benzilic acid | Hydrochlorothiazide | Sertraline Hydrochloride |
| Benzocaine | Hydrocortisone | Sildenafil Citrate |
| Benzoic acid | Ibuprofen | Simvastatin |
| Bilirubin | Isoxsuprine | Sulfamethazine |
| Bupropion | Ketamine | Sulindac |
| Captopril | Ketoprofen | Tetrahydrozoline |
| Carbamazepine | Labetalol | Theophylline |
| Cefradine | Levofloxacin Hydrochloride | Thiamine |
| Cephalexin | Levonorgestrel | Thioridazine |
| Chloral Hydrate | Levothyroxine Sodium | Tramadol Hydrochloride |
| Chloramphenicol | Lidocaine Hydrochloride | Trazodone Hydrochloride |
| Chlorothiazide | Lisinopril | Triamterene |
| chlorpheniramine | Loperamide | Trifluoperazine |
| Cholesterol | Loratadine | Trimethoprim |
| Ciprofloxacin Hydrochloride | Magnesium | Uric Acid |
| Citalopram | Meperidine | Venlafaxine HCl |
| Clarithromycin | Meprobamate | Verapamil |
| Clonidine | Metoprolol Tartrate | Vitamin B2 |
| Clozapine | Mifepristone | Vitamin C (Ascorbic acid) |
| Conjugated Estrogens | N-Acetylprocainamide | Zomepirac |
| Cortisone | Nalidixic Acid | ẞ-Estradiol |
| Cotinine | Naproxen | Chlorpromazine |
| Creatinine | Niacinamide | Perphenazine |
| D,L- Isoproterenol | Nicotine | Tetrahydrocortisone 3-(ß-D- |
| glucuronide) | ||
| D,L-Octopamine | Nifedipine | Tetrahydrocortisone 3-acetate |
| D,L-Propranolol | Nitroglycerin | Ecgonine methyl ester |
| D,L-Tryptophan | Norethindrone | Methoxyphenamine (except |
| MET test) | ||
| D,L-Tyrosine | Noscapine | Naloxone |
| Deoxycorticosterone | O-Hydroxyhippuric Acid | Naltrexone |
| Dextromethorphan | Omeprazole | Tyramine (except AMP test) |
| Diclofenac |
23
24
Effect of Urinary pH and Specific Gravity:
Interference by urinary pH and specific gravity were also evaluated using pooled urine specimens with concentrations of 0 (drug-free), at 25% below and 25% above each corresponding cutoff. The results demonstrated that pH levels of 4 to 9 and specific gravity levels of 1.000 to 1.035 do not affect the results of the assays.
B. Method Comparison Study
The method comparison studies for the device were performed in-house with three operators. Operators ran 80 (40 negative and 40 positive) unaltered urine clinical samples for each drug. The samples were blind labeled and compared to LC-MS/MS results are presented in the table below:
| Drug
test | Test Dipcard
Result | Drug-Free | Low
Negative by
LC-MS/MS
(less than
-50%) | Near Cutoff
Negative by
LC-MS/MS
(Between
-50% and
the Cutoff) | Near Cutoff
Positive by
LC-MS/MS
(Between
the cutoff
and +50%) | High
Positive by
LC-MS/MS
(greater
than +50%) | | |
|----------------------|------------------------|-----------|-------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------------------------------------------------------|----|---|
| AMP
(AMP
1000) | Viewer A | + | 0 | 0 | 0 | 7 | 31 | |
| | | - | 15 | 8 | 17 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 6 | 31 | |
| | | - | 15 | 8 | 17 | 3 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 6 | 31 | |
| | | - | 15 | 8 | 17 | 3 | 0 | |
| AMP
(AMP
500) | Viewer A | + | 0 | 0 | 0 | 8 | 30 | |
| | | - | 15 | 12 | 13 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 8 | 30 | |
| | | - | 15 | 12 | 13 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 8 | 30 | |
| | | - | 15 | 12 | 13 | 2 | 0 | |
| BAR | Viewer A | + | 0 | 0 | 0 | 16 | 22 | |
| | | - | 15 | 18 | 7 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 16 | 22 | |
| | | - | 15 | 18 | 7 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 15 | 22 | |
| | | - | 15 | 18 | 7 | 3 | 0 | |
| BUP | Viewer A | + | 0 | 0 | 2 | 29 | 10 | |
| | | - | 15 | 13 | 10 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 29 | 10 | |
| | | - | | 13 | 10 | 1 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 29 | 10 | |
| | | - | | 13 | 11 | 1 | 0 | |
| BZO | Viewer A | + | 0 | 0 | 1 | 8 | 31 | |
| | | - | | 11 | 13 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 7 | 31 | |
| | | - | | 11 | 12 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 7 | 31 | |
| | | - | | 11 | 13 | 2 | 0 | |
| COC | Viewer A | + | 0 | 0 | 2 | 11 | 27 | |
| (COC | | - | | 13 | 10 | 2 | 0 | |
| 300) | Viewer B | + | 0 | 0 | 1 | 11 | 27 | |
| | | - | | 13 | 11 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 2 | 11 | 27 | |
| | | - | | 13 | 10 | 2 | 0 | |
| COC | Viewer A | + | 0 | 0 | 1 | 13 | 25 | |
| (COC | | - | | 12 | 12 | 2 | 0 | |
| 150) | Viewer B | + | 0 | 0 | 1 | 13 | 25 | |
| | | - | | 12 | 12 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 13 | 25 | |
| | | - | | 12 | 12 | 2 | 0 | |
| EDDP | Viewer A | + | 0 | 0 | 1 | 11 | 29 | |
| | | - | | 6 | 18 | 0 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 11 | 29 | |
| | | - | | 6 | 19 | 0 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 11 | 29 | |
| | | - | | 6 | 18 | 0 | 0 | |
| MDMA | Viewer A | + | 0 | 0 | 1 | 9 | 30 | |
| | | - | | 14 | 10 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 9 | 30 | |
| | | - | | 14 | 11 | 1 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 9 | 30 | |
| | | - | | 14 | 10 | 1 | 0 | |
| MET | Viewer A | + | 0 | 0 | 0 | 8 | 30 | |
| (MET | | - | | 8 | 17 | 2 | 0 | |
| 1000) | Viewer B | + | 0 | 0 | 0 | 8 | 30 | |
| | | - | | 8 | 17 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 8 | 30 | |
| | | - | | 8 | 17 | 2 | 0 | |
| MET | Viewer A | + | 0 | 0 | 0 | 10 | 30 | |
| (MET | | - | | 14 | 11 | 0 | 0 | |
| 500) | Viewer B | + | 0 | 0 | 0 | 9 | 30 | |
| | | - | | 14 | 11 | 1 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 9 | 30 | |
| | | - | 15 | 14 | 11 | 1 | 0 | |
| OPI
(MOP
2000) | Viewer A | + | 0 | 0 | 2 | 9 | 29 | |
| | | - | 15 | 9 | 14 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 9 | 29 | |
| | | - | 15 | 9 | 14 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 2 | 9 | 29 | |
| | | - | 15 | 9 | 14 | 2 | 0 | |
| MOP
(MOP
300) | Viewer A | + | 0 | 0 | 2 | 18 | 21 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 19 | 21 | |
| | | - | 15 | 12 | 11 | 0 | 0 | |
| | Viewer C | + | 0 | 0 | 2 | 18 | 21 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| MTD | Viewer A | + | 0 | 0 | 2 | 9 | 30 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 8 | 30 | |
| | | - | 15 | 12 | 11 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 2 | 9 | 30 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| OXY | Viewer A | + | 0 | 0 | 2 | 10 | 29 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 2 | 9 | 29 | |
| | | - | 15 | 12 | 11 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 2 | 10 | 29 | |
| | | - | 15 | 12 | 11 | 1 | 0 | |
| PCP | Viewer A | + | 0 | 0 | 0 | 27 | 12 | |
| | | - | 15 | 13 | 12 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 28 | 12 | |
| | | - | 15 | 13 | 12 | 0 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 27 | 12 | |
| | | - | 15 | 13 | 12 | 1 | 0 | |
| PPX | Viewer A | + | 0 | 0 | 2 | 11 | 28 | |
| | | - | 15 | 13 | 10 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 1 | 12 | 28 | |
| | | - | 15 | 13 | 11 | 0 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 10 | 28 | |
| | | - | 15 | 13 | 11 | 2 | 0 | |
| TCA | Viewer A | + | 0 | 0 | 0 | 6 | 32 | |
| | | - | 15 | 13 | 12 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 0 | 6 | 32 | |
| | | - | 15 | 13 | 12 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 0 | 6 | 32 | |
| | | | - | 15 | 13 | 12 | 2 | 0 |
| THC | Viewer A | + | 0 | 0 | 2 | 9 | 30 | |
| | | - | 15 | 13 | 10 | 1 | 0 | |
| | Viewer B | + | 0 | 0 | 1 | 9 | 30 | |
| | | - | 15 | 13 | 11 | 1 | 0 | |
| | Viewer C | + | 0 | 0 | 1 | 9 | 30 | |
| | | - | 15 | 13 | 11 | 1 | 0 | |
| 6-MAM | Viewer A | + | 0 | 0 | 3 | 28 | 10 | |
| | | - | 15 | 13 | 9 | 2 | 0 | |
| | Viewer B | + | 0 | 0 | 3 | 28 | 10 | |
| | | - | 15 | 13 | 9 | 2 | 0 | |
| | Viewer C | + | 0 | 0 | 3 | 28 | 10 | |
| | | - | 15 | 13 | 9 | 2 | 0 | |
25
26
27
Discordant Results are summarized below.
| Drug | Operator | Sample Number | LC/MS/MS
Result (ng/mL) | Dochek Result |
|----------|----------------|---------------|----------------------------|---------------|
| 6-MAM 10 | Viewer A, B, C | 1091 | 9.006 | + |
| | Viewer A, B, C | 1081 | 9.465 | + |
| | Viewer A, B, C | 1053 | 9.967 | + |
| | Viewer A, B, C | 1048 | 10.237 | - |
| | Viewer A, B, C | 1052 | 10.257 | - |
| AMP 1000 | Viewer A, B, C | 0955 | 1014.625 | - |
| | Viewer A, B, C | 0936 | 1056.71 | - |
| | Viewer B, C | 0903 | 1141.794 | - |
| BAR 300 | Viewer A, B, C | 0221 | 302.963 | - |
| | Viewer C | 0238 | 304.207 | - |
| | Viewer A, B, C | 0173 | 312.828 | - |
| BUP 10 | Viewer A, B, C | 0136 | 8.76 | + |
| | Viewer A, B | 0137 | 8.785 | + |
| | Viewer A, B, C | 0141 | 10.761 | - |
| BZO 300 | Viewer B | 0405 | 269.424 | + |
| | Viewer A, B, C | 0428 | 290.449 | + |
| | Viewer B, C | 0422 | 301.512 | - |
| | Viewer A, B, C | 0409 | 301.586 | - |
| COC 300 | Viewer A, B, C | 0632 | 284.614 | + |
| | Viewer A, C | 0602 | 295.071 | + |
| | Viewer A, B, C | 0620 | 307.773 | - |
| | Viewer A, B, C | 0630 | 308.012 | - |
| EDDP 300 | Viewer A, C | 1591 | 296.944 | + |
| MDMA 500 | Viewer A, C | 0762 | 458.975 | + |
| | Viewer A, B, C | 0750 | 565.340 | - |
| | | | | |
| MET 1000 | Viewer A, B, C | 0972 | 1002.105 | - |
| | Viewer A, B, C | 1025 | 1026.596 | - |
| OPI 2000 | Viewer A, B, C | 0817 | 1872.771 | + |
| | Viewer A, B, C | 0855 | 1996.034 | + |
| | Viewer A, B, C | 0879 | 2022.484 | - |
| | Viewer A, B, C | 0880 | 2137.854 | - |
| MTD 300 | Viewer A, B, C | 1159 | 271.186 | + |
| | Viewer A, B, C | 1185 | 273.035 | + |
| | Viewer A, B, C | 1129 | 308.556 | - |
| | Viewer B | 1123 | 324.733 | - |
| OXY 100 | Viewer A, B, C | 0379 | 85.212 | + |
| | Viewer A, B, C | 0375 | 87.649 | + |
| | Viewer B | 0397 | 106.706 | - |
| | Viewer A, B, C | 0340 | 108.7 | - |
| PCP 25 | Viewer A, C | 0053 | 25.901 | - |
| PPX 300 | Viewer A, B, C | 0504 | 285.846 | + |
| | Viewer A | 0487 | 295.988 | + |
| | Viewer A, C | 0536 | 347.008 | - |
| | Viewer C | 0551 | 355.750 | - |
| TCA 1000 | Viewer A, B, C | 0688 | 1,051.49 | - |
| | Viewer A, B, C | 0653 | 1,135.56 | - |
| THC 50 | Viewer A, C | 0300 | 41.179 | + |
| | Viewer A, B | 0317 | 49.391 | + |
| | Viewer A, B, C | 0312 | 55.644 | - |
| AMP 500 | Viewer A, B, C | 1345 | 512.815 | - |
| | Viewer A, B, C | 1297 | 545.751 | - |
| COC 150 | Viewer A, B, C | 1446 | 138.861 | + |
| | Viewer A, B, C | 1512 | 156.470 | - |
| | Viewer A, B, C | 1505 | 162.099 | - |
| MET 500 | Viewer B, C | 1403 | 507.553 | - |
| MOP 300 | Viewer A, B, C | 1279 | 248.796 | + |
| | Viewer A, B, C | 1259 | 249.557 | + |
| | Viewer A, C | 1264 | 308.896 | - |
28
C. Lay Person Study
79 male and 61 female tested Dochek® Multi-Drug Urine Test Dipcard Configuration 1; 73 male and 67 female tested Dochek® Multi-Drug Urine Test Dipcard Configuration 2. They had diverse educational and occupational backgrounds and their age range from 21 to > 50. Urine samples were prepared at the following concentrations; -100%, +/-75%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC-MS/MS. Each sample was aliquoted into individual containers and blind-labeled. Each
29
participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below.
| Drug | Cutoff
(ng/mL) | Results | Drug Concentration | | | | | | |
|-------|-------------------|--------------------------------------|--------------------|----------------|----------------|----------------|----------------|----------------|----------------|
| | | | -100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff |
| AMP | 1000 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| BUP | 10 | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| COC | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| MDMA | 500 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| MET | 1000 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| OPI | 2000 | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| MTD | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| OXY | 100 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| PCP | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | 25 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| PPX | 300 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| | | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| TCA | 1000 | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
| THC | 50 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% |
| 6-MAM | 10 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | Percentage of correct
results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
Result of Dochek® Multi-Drug Urine Test Dipcard Configuration 1:
30
31
Result of Dochek® Multi-Drug Urine Test Dipcard Configuration 2:
| Drug | Cutoff
(ng/mL) | Results | Drug Concentration | | | | | | | |
|----------|-------------------|--------------------------------------|--------------------------------------|----------------|----------------|----------------|----------------|----------------|----------------|------|
| | | | -100%
cutoff | -75%
cutoff | -50%
cutoff | -25%
cutoff | +25%
cutoff | +50%
cutoff | +75%
cutoff | |
| AMP | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| BAR | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| | | | | | | | | | | |
| BUP | 10 | Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% | |
| BZO | 300 | Negative | 20 | 20 | 20 | 19 | 1 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 19 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 95% | 100% | 100% | |
| COC | 150 | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% | |
| EDDP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MDM
A | 500 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MET | 500 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | |
| MOP | 300 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | |
| | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% | |
| MTD | 300 | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| | | | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% |
| | | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| OXY | 100 | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| | | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| PCP | 25 | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| PPX | 300 | | Negative | 20 | 20 | 20 | 18 | 1 | 0 | 0 |
| | | | Positive | 0 | 0 | 0 | 2 | 19 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 90% | 95% | 100% | 100% |
| TCA | 1000 | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
| THC | 50 | | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 |
| | | | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of
correct results (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% |
| 6-MAM | 10 | | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 |
| | | | Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 |
| | | | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| | | | Percentage of correct
results (%) | 100% | 100% | 100% | 95% | 100% | 100% | 100% |
32
33
Participants were given surveys on the ease of understanding the instruction for use. All participants indicated that the device instruction is easy to understand and follow. A Flesch-Kincaid reading analysis was performed on each package insert and the scores revealed a reading Grade Level of 7.
34
D. Clinical Studies
Not applicable.
13. Conclusion
Based on the test principle and performance characteristics of the device including precision, cut-off, interference, specificity, method comparison and lay-user studies of the devices, it's concluded that Dochek® Multi-Drug Urine Test Dipcard Rx and Dochek® Multi-Drug Urine Test Dipcard are substantially equivalent to the predicate devices.