(41 days)
Dochek® Multi-Drug Urine Test Cup is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 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 postive 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 Cup Pro is an immunoassay for the qualitative determination of single or multiple drugs in human urine at the following cutoff concentrations.
Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
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 Cup Pro and Dochek® Multi-Drug Urine Test Cup 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 single use in vitro diagnostic medical devices.
This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.
The provided text describes the Dochek® Multi-Drug Urine Test Cup and Dochek® Multi-Drug Urine Test Cup Pro, which are immunoassays for the qualitative determination of single or multiple drugs in human urine. The acceptance criteria and the studies performed to demonstrate performance are detailed below. It is important to note that the acceptance criteria are implied by the reported performance, as explicit criteria are not stated in terms of thresholds for sensitivity/specificity. Instead, the studies demonstrate accuracy and agreement against a reference method and other concentrations.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the goal of demonstrating substantial equivalence to a predicate device and achieving certain performance levels in precision, accuracy against a reference method, and lay user comprehension.
Notes on the tables below:
- "Cutoff" refers to the specified ng/mL for each drug.
- "+" indicates a preliminary positive result (drug detected).
- "-" indicates a negative result (drug not detected).
- LC-MS/MS is the reference method for confirming drug concentrations.
- The "Percentage of correct results (%)" in the Lay User Study is derived from the reported counts of negative and positive results compared to the expected outcome given the drug concentration relative to the cutoff. For example, a sample at -100% cutoff should be negative, and a sample at +100% cutoff should be positive.
1.1. Precision/Reproducibility Study (Fentanyl (FTY) Example)
| Drug | Lot Number | Drug Concentration Categories (relative to Cutoff = 1 ng/mL) | Reported Performance (Negative/Positive) | Implied Acceptance Criteria |
|---|---|---|---|---|
| FTY | Lot I | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 12-/38+ (76% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative | ||
| FTY | Lot II | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 11-/39+ (78% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative | ||
| FTY | Lot III | +100%, +75%, +50%, +25% | 0-/50+ (100% Positive) | 100% Positive |
| Cutoff (1 ng/mL) | 11-/39+ (78% Positive) | High % Positive | ||
| -25%, -50%, -75% | 50-/0+ (100% Negative) | 100% Negative | ||
| -100% | 50-/0+ (100% Negative) | 100% Negative |
1.2. Method Comparison Study (Fentanyl (FTY) Example)
This study compares the device's results to LC-MS/MS, a highly accurate confirmatory method. The "Discordant results" highlight where the device deviated from the LC-MS/MS findings.
| Drug | LC-MS/MS Result Category | Device Result | Viewer A | Viewer B | Viewer C | Implied Acceptance Criteria |
|---|---|---|---|---|---|---|
| FTY | Drug-Free (< -50% Cutoff) | + | 0 | 0 | 0 | High Specificity (True Negative Rate): Device results should almost always be negative for drug-free samples. High Sensitivity (True Positive Rate): Device results should almost always be positive for samples significantly above cutoff. Acceptable Performance near Cutoff: A certain level of agreement, but with some expected variability, is tolerated for samples near the cutoff, demonstrating the device's ability to discriminate around the threshold. |
| - | 10 | 10 | 10 | |||
| Low Negative (< -50% Cutoff) | + | 0 | 0 | 0 | ||
| - | 14 | 14 | 14 | |||
| Near Cutoff Negative (Between -50% and Cutoff) | + | 0 | 0 | 1 | ||
| - | 16 | 16 | 15 | |||
| Near Cutoff Positive (Between Cutoff and +50%) | + | 25 | 25 | 25 | ||
| - | 2 | 2 | 2 | |||
| High Positive (> +50% Cutoff) | + | 13 | 13 | 13 | ||
| - | 0 | 0 | 0 |
Summary of Discordant Fentanyl Results (FTY 1 ng/mL):
| Drug | Operator | Sample ID | LC-MS/MS Result (ng/mL) | Dochek Result (Viewer) | Expected Result (based on Cutoff=1 ng/mL) | Discordance type |
|---|---|---|---|---|---|---|
| FTY | Viewer C | F046 | 0.945 | + | - | False Positive |
| FTY | Viewer A, B, C | F062 | 1.012 | - | + | False Negative |
| FTY | Viewer A, C | F083 | 1.020 | - | + | False Negative |
| FTY | Viewer B | F049 | 1.044 | - | + | False Negative |
1.3. Lay Person Study (Configuration 1 & 2 - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, OPI, MTD, OXY, PCP, PPX, TCA, THC, 6-MAM, FTY)
This study evaluates the device's performance when used by non-professionals. Results are generally expected to be 100% correct for samples at -100% and +100% of the cutoff, and high percentages for other concentrations (e.g., ≥90-95% for +/-25% of cutoff).
| Drug (Cutoff shown) | Results Category | Drug Concentration Categories (relative to Cutoff) | Reported Performance (% Correct Results) | Implied Acceptance Criteria (Typically ≥95% at +/-25% cutoff, 100% elsewhere) |
|---|---|---|---|---|
| AMP (1000 ng/mL) | Correct | -100%, -75%, -50%, -25% | 100% | 100% |
| +25%, +50%, +75% | 100% | 100% | ||
| BAR (300 ng/mL) | Correct | -100%, -75%, -50%, -25% | 100% | 100% |
| +25% | 95% | high % (e.g., ≥90%) | ||
| +50%, +75% | 100% | 100% | ||
| ... similar data for many drugs ... | ||||
| FTY (1 ng/mL) | Correct | -100%, -75%, -50% | 100% | 100% |
| -25% | 95% | high % (e.g., ≥90%) | ||
| +25%, +50%, +75% | 100% | 100% |
2. Sample Size and Data Provenance
Precision Study:
- Sample Size (Test Set): For Fentanyl, 50 tests were performed at each of the 9 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff) across 3 lots, for a total of 9 concentrations * 50 measurements * 3 lots = 1350 tests.
- Data Provenance: Samples were prepared by spiking target drug in drug-free urine samples. The source of the drug-free urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study, with samples specifically prepared for the testing.
Method Comparison Study:
- Sample Size (Test Set): 80 unaltered clinical urine samples were used for each drug (40 negative and 40 positive). For Fentanyl, this means 80 samples were tested.
- Data Provenance: Unaltered clinical urine samples. The country of origin of these clinical samples is not specified. This appears to be a retrospective study using existing clinical samples.
Lay Person Study:
- Sample Size (Test Set): 280 lay users participated.
- Configuration 1: 140 users (68 male, 72 female).
- Configuration 2: 138 users (74 male, 64 female).
- Across 7 concentration levels (+/-100%, +/-75%, +/-50%, +/-25% of cutoff, and cutoff), with 20 samples per concentration level for each drug. This means for each drug, 7 * 20 = 140 results were generated by lay users.
- Data Provenance: Urine samples were prepared by spiking drug(s) into drug-free pooled urine specimens. The source of the drug-free pooled urine or spiked drugs is not explicitly stated in terms of country of origin. This was a prospective study.
3. Number of Experts and Qualifications for Ground Truth
- Precision Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. This method is a highly qualified and generally accepted gold standard for drug concentration determination, not relying on human expert interpretation of the test result itself.
- Method Comparison Study: Ground truth was established by LC-MS/MS results. The operators in this study were "three operators" (presumably laboratory personnel or technicians, but their specific qualifications are not detailed). These operators read the device results, which were then compared to the LC-MS/MS ground truth.
- Lay Person Study: Ground truth for sample concentrations was confirmed by LC-MS/MS. The lay users themselves provided the device readings, and the percentage of correct results was calculated against the LC-MS/MS confirmed concentrations.
4. Adjudication Method for the Test Set
- Precision Study: The results are quantitative (counts of positive/negative) based on pre-defined concentrations. No adjudication method is explicitly described for subjective interpretation as the test is qualitative and the results are directly read as positive or negative by trained personnel (implied).
- Method Comparison Study: "Three operators" read the device results. The individual results for each viewer (A, B, C) are presented. There is no explicit adjudication method (e.g., 2-out-of-3 consensus) mentioned to derive a single device result per sample if the operators disagreed. The discordant results table shows instances where operators disagreed, or where the device result from an individual operator disagreed with LC-MS/MS.
- Lay Person Study: Lay users performed the tests independently. There is no mention of an adjudication process among lay users for their readings. Each participant provided a single result for their assigned sample/device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned to quantify the improvement of human readers with AI assistance versus without AI assistance. The device is a lateral flow immunoassay, not an AI-powered diagnostic for image interpretation or similar tasks often associated with MRMC studies.
6. Standalone Performance Study
Yes, standalone performance was conducted for the device.
- Precision Study: The device's inherent precision was evaluated across different drug concentrations and lots, independent of human interpretation variability (though human reading is still involved for the qualitative result).
- Method Comparison Study: The device's performance against the gold standard (LC-MS/MS) was evaluated by three operators independently, representing a standalone assessment of the device's accuracy in a laboratory setting.
- Lay Person Study: This study specifically assessed the standalone performance of the device when used by the intended lay users, including their ability to follow instructions and interpret results correctly.
7. Type of Ground Truth Used
The primary ground truth used for evaluating the device's accuracy in all relevant studies (Precision, Method Comparison, Lay Person) was:
- LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry): This is a highly sensitive and specific analytical chemistry technique used to precisely confirm the presence and concentration of drugs and their metabolites in urine samples. This serves as the objective, quantitative ground truth for drug concentrations.
8. Sample Size for the Training Set
The provided document describes performance studies (precision, method comparison, lay person study) for the Dochek® Multi-Drug Urine Test Cup devices. These are immunoassay devices, not machine learning or AI-based devices that typically have "training sets" in the computational sense. The document does not describe any such training set for an algorithm. The development of the immunoassay itself relies on chemical and biological principles rather than algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since there is no "training set" in the context of a machine learning algorithm for this immunoassay device, this question is not applicable. The device's performance characteristics are inherent to its biochemical design.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
February 20, 2025
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, Guangdong 510663 China
Re: K250067
Trade/Device Name: Dochek® Multi-Drug Urine Test Cup: Dochek® Multi-Drug Urine Test Cup Pro Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL, NFT, PTH, NFV, NFY, PTG, NGG, NGM, QBF, QAW, NFW Dated: January 10, 2025 Received: January 10, 2025
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
{2}------------------------------------------------
assistance/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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is from Joseph A. Kotarek. The date of the signature is 2025.02.20, and the time is 09:07:05-05'00'.
Joseph Kotarek, Ph.D. Branch Chief 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) K250067
Device Name
Dochek® Multi-Drug Urine Test Cup Dochek® Multi-Drug Urine Test Cup Pro
Indications for Use (Describe)
Dochek® Multi-Drug Urine Test Cup 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 |
| Fentanyl (FTY) | 1 ng/mL |
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 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 postive 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 Cup Pro 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 |
{4}------------------------------------------------
| Nortriptyline (TCA) | 1000 ng/mL |
|---|---|
| Cannabinoids (THC) | 50 ng/mL |
| 6-Monoacetylmorphine (6-MAM) | 10 ng/mL |
| Fentanyl (FTY) | 1 ng/mL |
| Dochek® Multi Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration |
Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
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.
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}------------------------------------------------
510(k) SUMMARY
510(k) number: K250067
| 1. | Date: | February 17, 2025 |
|---|---|---|
| 2. | Submitter: | Guangzhou Decheng Biotechnology Co., Ltd.Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, ScienceCity, Huangpu District, Guangzhou, Guangdong, 510663, P.R. ChinaContact Person: Mango HuangContact Email Address: mango.huang@dochekbio.comTelephone: +86-020-82557192 |
| 3. | Correspondent: | Guangzhou Decheng Biotechnology Co., Ltd.Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, ScienceCity, Huangpu District, Guangzhou, Guangdong, 510663, P.R. ChinaContact Person: Mango HuangContact Email Address: mango.huang@dochekbio.comTelephone: (888) 695-5248 |
| 4. | Device Name: | Dochek® Multi-Drug Urine Test Cup ProDochek® Multi-Drug Urine Test Cup |
-
- Classification: Class II
| Product Code | Regulation Section | Panel |
|---|---|---|
| Target Drug | ||
| NFTAmphetamine (AMP) | 862.3100, Amphetamine TestSystem | Toxicology |
| PTHSecobarbital (BAR) | 862.3150, Barbiturate Test System | Toxicology |
| NGLBuprenorphine (BUP)Morphine (MOP/OPI)Oxycodone (OXY)6-Monoacetylmorphine (6-MAM)Fentanyl (FTY) | 862.3650, Opiate Test System | Toxicology |
| NFVOxazepam (BZO) | 862.3170, Benzodiazepine TestSystem | Toxicology |
| NFYCocaine (COC) | 862.3250, Cocaine and cocainemetabolite test system | Toxicology |
| PTG2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP)Methadone (MTD) | 862.3620, Methadone Test System | Toxicology |
{6}------------------------------------------------
| NGGMethylenedioxymethamphetamine(MDMA)Methamphetamine (MET) | 862.3610,Methamphetamine Test System | Toxicology |
|---|---|---|
| NGMPhencyclidine (PCP) | Unclassified | Toxicology |
| QBFPropoxyphene (PPX) | 862.3700 Propoxyphene testsystem. | Toxicology |
| QAWNortriptyline (TCA) | 862.3910 Tricyclic antidepressantdrugs test system | Toxicology |
| NFWCannabinoids (THC) | 862.3870, Cannabinoids TestSystem | Toxicology |
Purpose for Submission 6.
Modification of previously cleared devices (K232659) to add fentanyl device (1 ng/mL cutoff).
7. Predicate Devices
K232659 Dochek® Multi-Drug Urine Test Cup Rx Dochek® Multi-Drug Urine Test Cup
8. Intended Use
Dochek® Multi-Drug Urine Test Cup Pro 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 |
| Fentanyl (FTY) | 1 ng/mL |
{7}------------------------------------------------
Dochek® Multi-Drug Urine Test Cup Pro offers any combinations from 1 to 17 drugs but only one cutoff concentration under same drug condition will be included per device.
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 Cup 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 |
| Fentanyl (FTY) | 1 ng/mL |
Dochek® Multi-Drug Urine Test Cup offers any combinations from 1 to 17 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 9.
Dochek® Multi-Drug Urine Test Cup Pro and Dochek® Multi-Drug Urine Test Cup 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 single
{8}------------------------------------------------
use in vitro diagnostic medical devices.
This device is a cup format, with the test strips integrated into the plastic cup provided, and the urine sample is collected directly into the cup containing the strips. Each cup device is sealed in an aluminum foil pouch with two sachets of desiccant. The device is in a ready-to-use format and no longer requires assembly before use.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device(K232659) |
| Indication for use | Qualitative detection of drugs of abuse in urine. | Same |
| Intended use | For medical and other professional use, or over-the-counter use. | For prescription use or over-the-counter use. |
| Methodology | Competitive binding, lateral flowimmunochromatographic assay based on antigen-antibody reaction | Same |
| Type of Test | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Target Drug andCutoff Value | Target Drug | Cutoff (ng/mL) Same exceptFentanyl (FTY) 1 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 | |
| Fentanyl (FTY) | 1 | |
| Configurations | Test cup | Same |
| Differences | ||
| Number of drugsdetected | 17(Add fentanyl device with 1 ng/mL cutoff) | 16 |
10. Substantial Equivalence Information
{9}------------------------------------------------
11. Standard/Guidance Document Reference (if applicable)
None referenced.
12. Test Principle
Dochek® Multi-Drug Urine Test Cup Pro or Dochek® Multi-Drug Urine Test Cup is a 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.
13. Performance Characteristics
13.1. 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 and -100% cutoff. Samples with concentration of -100% cutoff were drug-free urines samples. 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 candidate device. The results for Fentanyl (FTY) are summarized in the following table. The precision data for Amphetamine (AMP), Secobarbital (BAR), Buprenorphine (BUP), Oxazepam (BZO), Cocaine (COC), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA), Morphine (MOP300/OPI2000), Methadone (MTD), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), Nortriptyline (TCA), Cannabinoids (THC) and 6-Monoacetylmorphine (6-MAM) were reported in K232659.
| Drug | LotNumber | +100%cutoff | +75%cutoff | +50%cutoff | +25%cutoff | Cutoff | -25%cutoff | -50%cutoff | -75%cutoff | -100%cut-off |
|---|---|---|---|---|---|---|---|---|---|---|
| FTY | 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+ |
{10}------------------------------------------------
B. Linearity/assay reportable range
Not applicable. This device is intended for qualitative use only.
C. Stability
The device is stable at 2-30℃ for 36 months based on real time stability study.
D. Detection Limit
Not applicable.
E. Analytical specificity/Interference
Specificity and Cross-Reactivity a.
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. The table below shows the minimum concentration of each compound that produced a positive result and its percent cross-reactivity. The cross-reactivity data for Amphetamine (AMP), Secobarbital (BAR), Buprenorphine (BUP), Oxazepam (BZO), Cocaine (COC), 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine (EDDP), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA), Morphine (MOP300/OPI2000), Methadone (MTD), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), Nortriptyline (TCA), Cannabinoids (THC) and 6-Monoacetylmorphine (6-MAM) were reported in K232659.
| Drug/Cutoff | Compound | Concentration(ng/mL) | % Cross-Reactivity |
|---|---|---|---|
| Fentanyl | 1.0 | 100% | |
| Acetyl fentanyl | 1.0 | 100% | |
| Acetyl norfentanyl | 10,000 | 0.01% | |
| Acrylfentanyl | 1.5 | 66.7% | |
| Butyryl fentanyl | 2.5 | 40% | |
| Fentanyl (FTY)(Cutoff = 1 ng/mL) | Carfentanil | 50 | 2% |
| (±)-3-cis-methylfentanyl | 50 | 2% | |
| 4-Fluoro-isobutyrylfentanyl | 5 | 20% | |
| Furanyl fentanyl | 2.8 | 35.7% | |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005% | |
| (±) β-hydroxythiofentanyl | 1.5 | 66.7% | |
| Isobutyryl fentanyl | 1.0 | 100% | |
| Ocfentanil | 1.8 | 55.6% | |
| Para-fluorobutyrylfentanyl (p-FBF) | 4 | 25% | |
| Para-fluoro fentanyl | 3 | 33.3% | |
| Sufentanil | 20 | 5% | |
| Valeryl fentanyl | 5 | 20% | |
| Alfentanil | 5,000 | 0.02% |
{11}------------------------------------------------
| Despropionyl fentanyl (4-ANPP) | 20,000 | 0.005% |
|---|---|---|
| Remifentanil | 10,000 | 0.01% |
| Norcarfentanil | 10,000 | 0.01% |
| Norfentanyl | 10,000 | 0.01% |
b. Interfering Substances
To evaluate the 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 level. Compounds that show no interference at a concentration of 100µg/mL are summarized in the following table.
| Acetaminophen | Dopamine HCl | Noscapine |
|---|---|---|
| Acetone (1000 mg/dL) | Doxepin (except TCA test) | Octopamine |
| Acetylsalicylic acid | Duloxetine | O-Hydroxyhippuric acid |
| Acyclovir | Ecgonine methyl ester | Omeprazole |
| Albumin (100 mg/dL) | Ephedrine (except MET test) | Oxalic acid (100 mg/dL) |
| Albuterol sulfate (Proair HFA) | Erythromycin | Oxazepam (except BZO test) |
| Aminophylline | Esomeprazole Magnesium | Oxolinic acid |
| Aminopyrine | Ethanol (1%) | Oxymetazoline |
| Amitriptyline (except TCA test) | Fenoprofen | Paliperidone (except FTY test) |
| Amobarbital (except BAR test) | Fluoxetine Hydrochloride | Papaverine |
| Amoxicillin | Fluphenazine | Penicillin G |
| Ampicillin | Furosemide | PenicillinV Potassium |
| Apomorphine | Gabapentin | Perphenazine |
| Aripiprazole | Galactose (10 mg/dL) | Phenacetin (Acetophenetidin) |
| Aspartame | Gamma Globulin (500mg/dL) | Phencyclidine (except PCP test) |
| Atomoxetine | Gentisic acid | Phenelzine |
| Atorvastatin Calcium | Glucose (3000 mg/dL) | Phenobarbital (except BAR test) |
| Atropine | Hemoglobin | Prednisone |
| Azithromycin | Hydralazine | Pregablin |
| Benzilic acid | Hydrochlorothiazide | Propoxyphene (except PPX test) |
| Benzocaine | Hydrocortisone | Propranolol |
| Benzoic acid | Ibuprofen | Pseudoephedrine |
| Benzoylecgonine (except COC test) | Imipramine (except TCA test) | Quinine |
| Bilirubin | Isoproterenol | Ranitidine |
| Boric Acid (1%) | Isoxsuprine | Rifampicin |
| Bupropion (except FTY test) | Ketamine | Risperidone (except FTY test) |
| Caffeine | Ketoprofen | Salicylic acid |
| Captopril | Labetalol | Secobarbital (except BAR test) |
| Carbamazepine | Levofloxacin Hydrochloride | Serotonin (5-Hydroxytyramine) |
| Cefradine | Levonorgestrel | Sertraline Hydrochloride |
| Cephalexin | Levothyroxine Sodium | Sildenafil Citrate |
| Chloral hydrate | Lidocaine | Simvastatin |
| Chloramphenicol | Lisinopril | Sulfamethazine |
| Chlorothiazide | Loperamide | Sulindac |
| Chlorpheniramine | Loratadine | Tetrahydrocortisone 3-(ß-D-glucuronide) |
| Chlorpromazine | Magnesium | Tetrahydrocortisone 3-acetate |
| Cholesterol | Maprotiline (except TCA test) | Tetrahydrozoline |
| Ciprofloxacin Hydrochloride | Meperidine | Theophylline |
| Citalopram | Meprobamate | Thiamine |
| Clarithromycin | Methapyrilene | Thioridazine |
| Clomipramine (except TCAtest) | Methaqualone | Tramadol Hydrochloride |
| Clonidine | Methoxyphenamine (exceptMET test) | Trazodone Hydrochloride |
| Clozapine | Metoprolol Tartrate | Triamterene |
| Conjugated Estrogens | Metronidazole | Trifluoperazine |
| Cortisone | Mifepristone | Trimethoprim |
| Cotinine | N-Acetylprocainamide | Tyramine (except AMP test) |
| Creatinine | NaCl (4000 mg/dL) | Urea (2000 mg/dL) |
| Cyclobenzaprine (except TCAtest) | Nalidixic acid | Uric acid |
| D,L-Tryptophan | Naloxone | Valproic acid (250 ug/mL) |
| D,L-Tyrosine | Naltrexone | Venlafaxine |
| Deoxycorticosterone | Naproxen | Verapamil |
| Desipramine (except TCAtest) | Niacinamide | Vitamin B2 |
| Dextromethorphan | Nicotine | Vitamin C (Ascorbic acid) |
| Diclofenac | Nifedipine | Zomepirac |
| Diflunisal | Nitroglycerin | ß-Estradiol |
| Digoxin | Norethindrone | |
| Diphenhydramine | Nortriptyline (except TCA test) |
{12}------------------------------------------------
{13}------------------------------------------------
Effect of Urinary pH and Specific Gravity ﻦ
Interference by 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 1.035 do not affect the results of the assays.
13.2 Method Comparison Study
A method comparison study for the candidate device was performed in-house by 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. The fentanyl results are presented in the table below. The accuracy data for Amphetamine (AMP), Secobarbital (BAR), Buprenorphine (BUP), Oxazepam (BZO), Cocaine (COC), 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Methamphetamine (MET), Methylenedioxymethamphetamine (MDMA), Morphine (MOP300/OPI2000), Methadone (MTD), Oxycodone (OXY), Phencyclidine (PCP), Propoxyphene (PPX), Nortriptyline (TCA), Cannabinoids (THC) and 6-Monoacetylmorphine (6-MAM) were reported in K232659.
| Drugtest | Test CupResult | 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%) | |
|---|---|---|---|---|---|---|---|
| FTY | Viewer A | + | 0 | 0 | 0 | 25 | 13 |
| - | 10 | 14 | 16 | 2 | 0 | ||
| Viewer B | + | 0 | 0 | 0 | 25 | 13 | |
| - | 10 | 14 | 16 | 2 | 0 | ||
| Viewer C | + | 0 | 0 | 1 | 25 | 13 | |
| - | 10 | 14 | 15 | 2 | 0 |
| Discordant results for fentanyl (FTY 1 ng/mL) are summarized below. | |||
|---|---|---|---|
| --------------------------------------------------------------------- | -- | -- | -- |
| Drug | Operator | Sample ID | LC-MS/MS Result(ng/mL) | Dochek Result |
|---|---|---|---|---|
| FTY | Viewer C | F046 | 0.945 | + |
| Viewer A, B, C | F062 | 1.012 | - | |
| Viewer A, C | F083 | 1.020 | - | |
| Viewer B | F049 | 1.044 | - |
{14}------------------------------------------------
13.3. Lay Person Study
A lay user study was conducted at three intended user sites by 280 lay users using three lots of the candidate device. The lay users had diverse educational and professional backgrounds and ranged in age from 21 to >50 years. 68 male and 72 female tested the Dochek® Multi-Drug Urine Test Cup for Configuration 1; 74 male and 64 female tested the Dochek® Multi-Drug Urine Test Cup for Configuration 2. Urine samples were prepared at the following concentrations: -100%, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug(s) into drug free-pooled urine specimens. The concentrations of the drugs in these 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 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 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| BUP | 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% | ||
| BZO | 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% | ||
| 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% | ||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | ||
| EDDP | 300 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | ||
| MDMA | 500 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | ||
| MET | 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% | ||
| 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% | ||
| Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | ||
| MTD | 300 | 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 | 19 | 0 | 0 | 0 | ||
| OXY | 100 | 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 | ||
| PCP | Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | ||
| 25 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | |
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 1 | 0 | 0 | ||
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | ||
| PPX | 300 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| TCA | Negative | 20 | 20 | 20 | 18 | 0 | 0 | 0 | |
| 1000 | Positive | 0 | 0 | 0 | 2 | 20 | 20 | 20 | |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 90% | 100% | 100% | 100% | ||
| 50 | Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | |
| Positive | 0 | 0 | 0 | 1 | 20 | 20 | 20 | ||
| THC | 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 | ||
| 6-MAM | 10 | 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 | ||
| Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 | ||
| FTY | 1 | Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% |
Results of Dochek® Multi-Drug Urine Test Cup for Configuration 1:
{15}------------------------------------------------
{16}------------------------------------------------
Results of Dochek® Multi-Drug Urine Test Cup for 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 | 20 | 1 | 0 | 0 |
| Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| BAR | 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% | ||
| 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 correctresults (%) | 100% | 100% | 100% | 100% | 100% | 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 | 150 | 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% | ||
| 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% | ||
| MDMA | 500 | 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% | ||
| 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 correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 19 | 0 | 0 | 0 | ||
| MOP | 300 | 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 | 19 | 1 | 0 | 0 | ||
| MTD | 300 | 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% | ||
| Negative | 20 | 20 | 20 | 20 | 2 | 0 | 0 | ||
| OXY | 100 | Positive | 0 | 0 | 0 | 0 | 18 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 90% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | ||
| PCP | 25 | 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 | 19 | 0 | 0 | 0 | ||
| PPX | 300 | 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 | 1 | 0 | 0 | ||
| TCA | 1000 | Positive | 0 | 0 | 0 | 0 | 19 | 20 | 20 |
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | ||
| THC | 50 | Positive | 0 | 0 | 0 | 0 | 20 | 20 | 20 |
| Negative | 20 | 20 | 20 | 20 | 0 | 0 | 0 | ||
| Total | 20 | 20 | 20 | 20 | 20 | 20 | 20 | ||
| Percentage of correctresults (%) | 100% | 100% | 100% | 100% | 100% | 100% | 100% | ||
| 6-MAM | 10 | 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 correctresults (%) | 100% | 100% | 100% | 100% | 95% | 100% | 100% | ||
| FTY | 1 | 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% |
{17}------------------------------------------------
{18}------------------------------------------------
{19}------------------------------------------------
Lay users completed given surveys on the ease of understanding the package insert. 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.
13.4 Clinical Studies
Not applicable.
14. 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 Cup Pro and Dochek® Multi-Drug Urine Test Cup are substantially equivalent to the predicate devices.
§ 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).