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 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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Dochek® Multi-Drug Urine Test Dipcard, based on the provided FDA 510(k) summary:

This device is an in-vitro diagnostic test, not an AI/ML device, so many of the requested criteria (e.g., number of experts, adjudication, MRMC study, training set) typically apply to AI/ML software. Therefore, I will adapt the response to describe the data provided for this type of diagnostic device.

Acceptance Criteria and Device Performance for Dochek® Multi-Drug Urine Test Dipcard

This device is a qualitative immunoassay for the detection of various drugs in human urine. The acceptance criteria and performance are primarily based on its analytical accuracy (precision, specificity, and comparison to a gold standard) and usability.

1. Table of Acceptance Criteria and Reported Device Performance

For this type of qualitative immunoassay, the primary acceptance criteria revolve around the device's ability to correctly classify samples as positive or negative at and around the specified cutoff concentrations. The "performance" is demonstrated through the observed concordance with confirmatory methods (LC-MS/MS) and its precision.

Acceptance Criteria Category	Specific Criteria (Implicitly from Study Design)	Reported Device Performance (Summary)
Analytical Precision	Consistent positive results for samples ≥ 25% above cutoff. Consistent negative results for samples ≤ 25% below cutoff. Acceptable percentage of positive/negative results at cutoff.	Observed Precision (Examples from various drugs and lots at cutoff): - AMP (1000 ng/mL): Lot I: 13-/37+, Lot II: 14-/36+, Lot III: 13-/37+ (out of 50 tests) - BAR (300 ng/mL): Lot I: 14-/36+, Lot II: 12-/38+, Lot III: 14-/36+ - COC (300 ng/mL): Lot II: 13-/37+, Lot III: 12-/38+ - MDMA (500 ng/mL): Lot I: 10-/40+, Lot II: 10-/40+, Lot III: 11-/39+ All samples ≥ +25% cutoff consistently showed "0-/50+" (0 negative, 50 positive). All samples ≤ -25% cutoff consistently showed "50-/0+" (50 negative, 0 positive).
Analytical Specificity	Minimal or no cross-reactivity with structurally unrelated compounds at specified concentrations. Acceptable cross-reactivity with structurally related compounds.	Extensive cross-reactivity tables provided (pages 13-22 in original document) for all 16 drugs. Many structurally related compounds showed cross-reactivity, requiring careful interpretation of results (e.g., Amphetamine panel detects other amphetamine-like substances). Many non-structurally related compounds showed no interference at 100 µg/mL.
Interference	Urinary pH (4-9) and Specific Gravity (1.000-1.035) should not affect results. Substances commonly found in urine should not interfere.	pH levels of 4-9 and specific gravity levels of 1.000-1.035 did not affect assay results. Over 100 non-structurally related compounds (e.g., acetaminophen, ibuprofen, glucose) showed no interference at 100 µg/mL. (Pages 22-23)
Method Comparison (Accuracy)	High concordance with a confirmed analytical method (LC-MS/MS) for both negative and positive samples, especially around the cutoff concentrations.	High concordance with LC-MS/MS. For each drug, 80 clinical samples (40 negative, 40 positive) were tested. The detailed tables (pages 24-27) show the breakdown of positive/negative calls by the dipcard vs. LC-MS/MS concentrations (drug-free, low negative, near cutoff negative, near cutoff positive, high positive). While some discordant results (false positives/negatives near cutoff) were observed, they are typical for qualitative immunoassay screening tests designed to be highly sensitive around the cutoff. The device generally performed as expected for a qualitative screening test.
Lay Person Usability	Lay users should be able to correctly interpret the device results and understand the instructions for use.	High (≥90%) correct result interpretation by lay users across various drug concentrations for the majority of tests. The "Percentage of correct results" for samples +/- 25% of cutoff varied (e.g., BAR 95%, BUP 90% for -25% cutoff; BUP 95% for +25% cutoff), indicating some variability by lay users near the cutoff, which is expected for visual interpretation of a qualitative test. All participants found the instructions easy to understand and follow, with a Flesch-Kincaid Grade Level of 7. (Pages 28-33)
Stability	The device should demonstrate stability over its claimed shelf life.	Demonstrated stability at 2-30°C for 36 months based on real-time stability study.

2. Sample Size and Data Provenance:

Test Set Sample Sizes:
- Precision/Reproducibility: For each drug and each of the three lots, 50 tests were performed at each of the 9 concentration levels around the cutoff (total of 450 tests per lot per drug for analytical precision). This was repeated for multiple lots.
- Method Comparison: 80 clinical urine samples were used for each drug. These 80 samples consisted of 40 negative and 40 positive samples, further categorized by their concentration relative to the cutoff (drug-free, low negative, near cutoff negative, near cutoff positive, high positive).
- Lay Person Study: 140 participants (79 male, 61 female for Configuration 1; 73 male, 67 female for Configuration 2). For each drug and concentration level, 20 samples were tested by lay users.
Data Provenance: The document generally indicates "in-house" studies for method comparison and precision. The clinical samples for method comparison were "unaltered urine clinical samples." The lay person study used pooled urine specimens spiked with drugs, confirmed by LC-MS/MS. The country of origin for the data is implied to be China, given the manufacturer's address (Guangzhou, China). The studies appear to be prospective in nature as they involved preparing samples and testing them using the device under controlled conditions to evaluate performance.

3. Number of Experts and Qualifications for Ground Truth:

This device is a qualitative immunoassay, not an AI/ML algorithm requiring expert interpretation of images. Therefore, the concept of "experts" to establish ground truth in the same way as for imaging AI is not directly applicable.
The ground truth for the analytical studies was established by LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate chemical method considered the gold standard for quantitative drug identification and concentration determination in urine.
For the method comparison study, "three operators" performed the tests. Their qualifications are not explicitly stated, but for a laboratory-based study of an immunoassay, these would typically be trained laboratory personnel or technicians.

4. Adjudication Method for the Test Set:

Not applicable in the context of an immunoassay device. The results are physical readouts (presence/absence of a line).
For the Method Comparison study, the device result (positive/negative) was compared directly to the quantitative LC-MS/MS result. Discordant results are individually listed (pages 27-28), showing which operators, if any, had differing readings from the LC-MS/MS ground truth. Since three operators independently read the same samples for the method comparison, consistency among them can be inferred, but formal "adjudication" is not described as they were simply recording what they observed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted for this device. This type of study is specifically designed for AI-assisted diagnostic tools (often in imaging) to compare human performance with and without AI assistance.
This device is a standalone diagnostic test; it does not "assist" human readers in the interpretation of complex data (like medical images).

6. Standalone (Algorithm Only) Performance:

Yes, in a sense. The "Performance Characteristics" section details the device's inherent analytical performance (precision, specificity, and method comparison against LC-MS/MS). These studies evaluate the device's ability to detect drugs independently of human interpretation nuances (though human "operators" did conduct the tests, the output is a visual line).
The "Lay Person Study" then evaluates the human interpretation of the device's output.

7. Type of Ground Truth Used:

The primary ground truth used throughout the studies (precision, method comparison) was GC/MS or LC/MS (Gas Chromatography/Mass Spectrometry or Liquid Chromatography/Mass Spectrometry) results. These are highly accurate, quantitative analytical chemistry methods considered definitive for drug presence and concentration.
For the lay person study, the "ground truth" for the samples was also established by LC-MS/MS confirmation of spiked drug concentrations.

8. Sample Size for the Training Set:

This device is a chemical immunoassay, not a machine learning model. Therefore, there is no "training set" in the context of algorithm development. The device's performance is inherent to its biochemical design.

9. How Ground Truth for Training Set was Established:

As stated above, no training set for an algorithm exists for this type of device. The scientific and engineering principles of immunoassay design and manufacturing determine its performance, which is then validated through the analytical and clinical studies described.

Summary

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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.

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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

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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

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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.

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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.

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.

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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.

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."

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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, NFTAmphetamine (AMP)	862.3100, Amphetamine Test System	Toxicology
DIS, PTHSecobarbital (BAR)	862.3150, Barbiturate Test System	Toxicology
DJG, NGLBuprenorphine (BUP)Morphine (MOP/OPI)Oxycodone (OXY)6-Monoacetylmorphine (6-MAM)	862.3650, Opiate Test System	Toxicology
JXM, NFVOxazepam (BZO)	862.3170, Benzodiazepine Test System	Toxicology
DIO, NFYCocaine (COC)	862.3250, Cocaine and cocainemetabolite test system	Toxicology
DJR, PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Methadone (MTD)	862.3620, Methadone Test System	Toxicology

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DJC, NGGMethylenedioxymethamphetamine(MDMA)Methamphetamine (MET)	862.3610,Methamphetamine Test System	Toxicology
LCM, NGMPhencyclidine (PCP)	Unclassified	Toxicology
JXN, QBFPropoxyphene (PPX)	862.3700 Propoxyphene test system.	Toxicology
LFG, QAWNortriptyline (TCA)	862.3910 Tricyclic antidepressantdrugs test system	Toxicology
LDJ, NFWCannabinoids (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

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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.

Device Description 8.

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

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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 flowimmunochromatographic assay based on antigen-antibody reaction	Same
Type of Test	Qualitative	Same
Specimen Type	Human urine	Same
Target Drugand CutoffValue	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

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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	LotNumber	+100%cutoff	+75%cutoff	+50%cutoff	+25%cutoff	Cutoff	-25%cutoff	-50%cutoff	-75%cutoff	-100%cut-off
AMP1000	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+
BAR300	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+
BUP10	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+
BZO300	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}------------------------------------------------

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

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-MethylenedioxymethamphetamineHCI(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-carboxyglucuronide
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)	<0.1%
	Buprenorphine	10,000(Negative)	<0.1%
	Dihydrocodeine	10,000(Negative)	<0.1%
	Nalorphine	5,000	0.2%
	Dextromethorphan	100,000(Negative)	Not detected
	Imipramine	100,000(Negative)	Not detected
	Levacetylmethadol (LAAM)	100,000(Negative)	Not detected
	Meperidine	100,000(Negative)	Not detected
	Methadone	100,000(Negative)	Not detected
	Mitragynine (kratom)	20,000(Negative)	<0.05%
	Morphine 6-D-glucuronide	100,000(Negative)	Not detected
	Naloxone	100,000(Negative)	Not detected
	Naltrexone	100,000(Negative)	Not detected
	Naproxen	100,000(Negative)	Not detected
	Norbuprenorphine	10,000(Negative)	<0.1%
	Norbuprenorphine glucuronide	100,000(Negative)	Not detected
	Norhydrocodone	100,000(Negative)	Not detected

	Noroxycodone	100,000(Negative)	Not detected
	Noroxymorphone	100,000(Negative)	Not detected
	Norpropoxyphene	100,000(Negative)	Not detected
	Oxymorphone-3β-D- glucuronide	100,000(Negative)	Not detected
	Tapentadol HCl	100,000(Negative)	Not detected
	Tramadol	100,000(Negative)	Not detected
	d-Amphetamine	500	100%
	d/l-Amphetamine	1,500	33.3%
	l-Amphetamine	25,000	2%
	(+/-) 3,4-methylenedioxyamphetamine(MDA)	2,500	20%
	Phentermine	1,500	33.3%
	Hydroxyamphetamine	5,000	10%
	d-Methamphetamine	100,000(Negative)	Not detected
	l-Methamphetamine	100,000(Negative)	Not detected
AMP 500	(+/-)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	0.5%
	Tyramine	100,000	0.5%
	p-Hydroxynorephedrine	100,000	0.5%
	Phenylpropanolamine	100,000(Negative)	Not detected
	(±)Phenylpropanolamine	100,000(Negative)	Not detected
	p-Hydroxyamphetamine	100,000	0.5%
	d/l-Norephedrine	100,000	0.5%
	Benzphetamine	100,000(Negative)	Not detected
	l-Epinephrine	100,000(Negative)	Not detected
	d/l-Epinephrine	100,000(Negative)	Not detected
COC 150	Benzoylecgonine	150	100%

	Cocaine HCl	500	30%
	Cocaethylene	5,000	3%
	Ecgonine	15,000	1%
	Ecgonine methyl ester	100,000(negative)	Not detected
	Norcocaine	100,000(negative)	Not detected
	d-Methamphetamine	500	100%
	d-Amphetamine	25,000	2%
	Chloroquine	25,000	2%
	(1R,2S)-(-)-Ephedrine	25,000	2%
	(-)-Methamphetamine	12,500	4%
	(+/-)3,4-methylenedioxumethamphetamine(MDMA)	2,000	25%
	β-Phenylethylamine	25,000	2%
	Trimethobenzamide	5,000	10%
	l-Amphetamine	50,000	1%
MET 500	(+/-)3,4-Methylenedioxyethylamphetamine(MDEA)	15,000	3.3%
	Mephentermine	25,000	2%
	Methoxyphenamine	25,000	2%
	Fenfluramine	37,500	1.3%
	Procaine	>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 (exceptMET 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:

Drugtest	Test DipcardResult	Drug-Free	LowNegative byLC-MS/MS(less than-50%)	Near CutoffNegative byLC-MS/MS(Between-50% andthe Cutoff)	Near CutoffPositive byLC-MS/MS(Betweenthe cutoffand +50%)	HighPositive byLC-MS/MS(greaterthan +50%)
AMP(AMP1000)	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(AMP500)	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(MOP2000)	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(MOP300)	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/MSResult (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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 correctresults (%)	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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect results (%)	100%	100%	100%	95%	100%	100%	100%
MDMA	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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 ofcorrect 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 correctresults (%)	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.

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).