(175 days)
Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.
Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
The provided document is a 510(k) summary for the Dochek® Fentanyl Urine Test System. It describes the device's performance through various studies.
Here's an analysis of the acceptance criteria and study details:
Device: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus
Intended Use: Qualitative detection of Fentanyl (FTY) in human urine at a cut-off concentration of 1 ng/mL for in vitro diagnostic (OTC) use.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate, pre-defined set of thresholds. Instead, it presents performance data from various studies. For the purpose of this response, I will consider a general expectation for such devices to perform accurately around the cutoff.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|---|
| Precision/Reproducibility | Expected high agreement for samples significantly above/below cutoff; some variability near cutoff. | For all device types and lots, 0ng/mL, 0.25ng/mL, 0.5ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL showed 100% agreement. Samples at 0.75ng/mL and 1.25ng/mL (near cutoff) showed expected variability (ranging from 86.7% to 100% agreement for negative/positive results respectively). |
| Analytical Specificity | Low cross-reactivity with structurally similar compounds; no interference from common medications/substances. | Detailed list of cross-reactivity percentages provided, indicating acceptable specificity. No interference was shown from a comprehensive list of opioids and commonly ingested medications/substances. |
| Method Comparison | High agreement with a confirmed analytical method (LC/MS). | Overall agreement rates with LC/MS were consistently 97.5% for all device types and all lots/operators. Discordant results were very close to the cutoff concentration. |
| Lay Person Study | High agreement from lay users interpreting the test results. | Agreement rates ranged from 92.5% to 100% across all concentrations and device types. Near-cutoff samples showed slightly lower, but still high, agreement. |
| Stability | Device remains effective over its shelf-life. | Stable at 2-30°C for 24 months based on real-time stability study. |
2. Sample Size Used for the Test Set and Data Provenance:
- Precision/Reproducibility Study:
- Test Set Size: For each concentration (0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL), 60 determinations were made per lot, with two operators independently reading results, leading to 60 results per concentration per lot. With 3 lots, this is 180 determinations per concentration, or 360 individual readings (across two operators).
- Data Provenance: The specimens were "drug-free specimens spiked with Fentanyl." No specific country of origin is mentioned, but the study was conducted over 10 non-consecutive days using three different lots of the device. This appears to be a prospective study using prepared samples.
- Method Comparison Study:
- Test Set Size: 80 clinical urine specimens were used. These were analyzed by LC/MS and by 3 lots of each Dochek® Fentanyl Urine Test product (Strip, Card, Cup). Therefore, for each device type, 80 samples were tested 3 times (once per lot/operator).
- Data Provenance: "Clinical urine specimens." No specific country of origin is mentioned. This appears to be a retrospective study using existing clinical samples.
- Lay Person Study:
- Test Set Size: 980 lay persons participated. For each concentration (0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL), the number of determinations per lot was 40 for the Strip and Cup, and 30 for the Card (cassette and dipcard). Each participant tested one blind-labeled sample.
- Data Provenance: The urine samples were "prepared at the following concentrations... by spiking target drug fentanyl into drug free urine specimens." This indicates samples were prepared for the study. No specific country of origin is mentioned for the lay persons, but the study was conducted at "three intended user sites." This appears to be a prospective study using artificially prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Precision/Reproducibility Study: The ground truth for concentrations (0ng/mL, 0.25ng/mL, etc.) was established by LC-MS/MS. The document does not specify the number or qualifications of experts operating the LC-MS/MS. Device results were read in duplicate by "two different operators," but these are device operators, not ground truth experts.
- Method Comparison Study: The ground truth was established by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS. The study was conducted by "3 laboratory professionals at the manufacturer site" who performed the Dochek® tests.
- Lay Person Study: The ground truth for sample concentrations was confirmed by LC/MS. The document does not specify the number or qualifications of experts operating the LC/MS.
4. Adjudication Method for the Test Set:
- Precision/Reproducibility Study: Results for the Dochek device were "read in duplicate by two different operators." It doesn't explicitly state an adjudication method (e.g., 2+1, 3+1). It seems individual operator readings were recorded per sample.
- Method Comparison Study: The document lists results for "Lot 1, operator 1," "Lot 2, operator 2," and "Lot 3, operator 3" separately. This suggests that each operator's reading for each lot was compared directly to the LC/MS benchmark, rather than an adjudication among the operators' readings for a single sample.
- Lay Person Study: Each participant was given one device and one blind-labeled sample. The "Layer user Results" are presented as total positive/negative counts. There's no mention of adjudication among lay users' interpretations for the same sample.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance:
No MRMC comparative effectiveness study was mentioned. The device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic. Thus, questions regarding human reader improvement with AI assistance are not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The device itself is a standalone, read by a human. There is no algorithm component described that would operate without human-in-the-loop for reading the results. The studies assess the performance of the device as it is intended to be used (i.e., with human interpretation).
7. The Type of Ground Truth Used:
The primary ground truth method used across all studies (precision, method comparison, and lay person) was LC/MS or LC-MS/MS (Liquid Chromatography-Mass Spectrometry/Mass Spectrometry). This is a highly accurate and precise analytical chemistry method for identifying and quantifying substances.
8. The Sample Size for the Training Set:
The document describes performance studies for premarket notification. It does not mention a "training set" in the context of machine learning or AI. The product is a diagnostic device, and the data presented are for validation and verification, not for training an algorithm.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a "training set" for an algorithm, this question is not applicable. The ground truth for the various performance evaluation samples (spiked samples, clinical samples) was established through LC/MS or LC-MS/MS.
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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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 6, 2025
Guangzhou Decheng Biotechnology Co., Ltd. Jenny Mao Regulatory Affairs Supervisor Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road Science City, Huangpu District Guangzhou, Guangdong 510663 China
Re: K242428
Trade/Device Name: Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus Dochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: December 20, 2024 Received: December 20, 2024
Dear Jenny Mao:
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.
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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.
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
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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,
Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2025.02.06 09:05:30 -05'00'
Joseph Kotarek Branch Chief for Toxicology 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) K242428
Device Name
Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup Plus
Indications for Use (Describe)
Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
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.
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:
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{5}------------------------------------------------
Indications for Use
510(k) Number (if known) K242428
Device Name
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Cup
Indications for Use (Describe)
Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{6}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{7}------------------------------------------------
Section 5- 510(k) SUMMARY
K242428
| 1. | Date: | 2025/2/5 |
|---|---|---|
| 2. | Submitter: | Guangzhou Decheng Biotechnology Co., Ltd.Address: Floor 3/4/5/7, Building A1, No.12, Nanyun 1st Road, Science City,Huangpu District, Guangzhou, Guangdong, 510663, P.R. ChinaContact Person: Jenny MaoContact Email Address: jenny.mao@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, Science City,Huangpu District, Guangzhou, Guangdong, 510663, P.R. ChinaContact Person: Jenny MaoContact Email Address: jenny.mao@dochekbio.comTelephone: +86-020-82557192 |
| 4. | Device Name | |
| Common Name: | Fentanyl (FTY) Test System | |
| Proprietary names: | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip PlusDochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card PlusDochek® Fentanyl Urine Test Cup, Dochek® Fentanyl Urine Test Cup Plus |
ട്. Classification: Class II
| Product Code | Regulation Section | Panel |
|---|---|---|
| NGL | 21 CFR 862.3650, Opiate Test System | Toxicology |
Predicate Devices: 6.
AllTest Fentanyl Rapid Test (Urine) (K231698)
7. Intended Use
Dochek® Fentanyl Urine Test Strip is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentany] Urine Test Card is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL.
It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result,
{8}------------------------------------------------
particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] (FTY) in human urine at the cut-off concentration of 1 ng/mL. It is intended for over-the-counter (OTC) use. For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Strip Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentany] Urine Test Card Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Dochek® Fentanyl Urine Test Cup Plus is a competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl (FTY) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
The test provides only preliminary results. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when the preliminary result is positive.
Device Description 8.
Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentany1 Urine Test Card, Dochek® Fentany] Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus are immunochromatographic assays that use a lateral flow system for the qualitative detection of fentanyl in human urine.
Test Strip, Test Card and Test Cup use identical test strips made with same chemical formulation and manufacturing procedures.
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| Item | Device | Predicate (K231698) |
|---|---|---|
| Indication for use | Qualitative detection of fentanyl in urine | Same |
| Intended Use | Professional/HCP Use and Over-The-Counter Use | Prescription Use |
| Specimen | Urine | Same |
| Cutoff | 1 ng/mL | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, lateral flowimmunochromatographic assay based on theprinciple of antigen antibody immunochemistry | Same |
| Configuration | Strip, card and cup | Cassette |
| Storage | 2-30°C | Same |
Substantial Equivalence Information: 9.
10. Standard/Guidance Document Reference (if applicable)
Draft Guidance for Industry and FDA Staff: Premarket Submission and Labeling Recommendations for Drugs of Abuse Screening Tests
11. Test Principle
The Fentanyl (FTY) Test System is an immunoassay based on the principle of competitive binding that is used to screen for the presence of Fentanyl in urine. It is a chromatographic absorbent device in which Fentanyl in a sample competitively combined to a limited number of antibody-dye conjugate binding sites.
During testing, the urine specimen migrates upward by capillary action. Fentanyl, if present in the urine specimen below 1 ng/mL, will not saturate the binding sites of antibody-coated particles in the test device. The antibody-coated particles will then be captured by immobilized FTY conjugate and a visible colored line will appear in the test region (T) to indicate a negative result. The colored line will not appear in the test region (T) if the Fentanyl level exceeds 1 ng/mL because it will saturate all the binding sites of anti-FTY antibodies and prevent the development of a distinct colored line, which indicating a positive result.
To serve as a procedure control, a colored line will always appear at the control region (C), if the test has been performed properly.
12. Performance Characteristics
A. Analytical performance
a. Precision/Reproducibility
Precision study was performed using drug-free specimens spiked with Fentanyl at different concentrations: 0ng/mL, 0.25ng/mL, 0.75ng/mL, 1ng/mL, 1.25ng/mL, 1.5ng/mL, 1.75ng/mL, and 2ng/mL. All concentrations were confirmed with LC-MS/MS. The study was performed 3 runs per day and lasted for 10 non-consecutive days using three different lots of Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentany] Urine Test Cup. 30 determinations were made for each concentration, and a total of 60 results were obtained per concentration per lot (each result was read in duplicate by two different operators).
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| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Lot 1 | Lot 2 | Lot 3 | |||
|---|---|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |||
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 8 | 52 | 4 | 56 | 4 | 56 |
| 1ng/mL | cutoff | 60 | 38 | 22 | 34 | 26 | 34 | 26 |
| 1.25ng/mL | +25% cutoff | 60 | 54 | 6 | 58 | 2 | 56 | 4 |
| 1.5ng/mL | +50% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Dochek® Fentanyl Urine Test Strip
Dochek® Fentany1 Urine Test Card
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Lot 1 | Lot 2 | Lot 3 | |||
|---|---|---|---|---|---|---|---|---|
| Positive | Negative | Positive | Negative | Positive | Negative | |||
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 6 | 54 | 2 | 58 | 4 | 56 |
| 1ng/mL | cutoff | 60 | 32 | 28 | 34 | 26 | 34 | 26 |
| 1.25ng/mL | +25% cutoff | 60 | 58 | 2 | 58 | 2 | 54 | 6 |
| 1.5ng/mL | +50% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
Dochek® Fentanyl Urine Test Cup
| Approximateconcentration | % of cutoff | Number ofdeterminationsper lot | Lot 1 | Lot 2 | Lot 3 | |||
|---|---|---|---|---|---|---|---|---|
| of sample | Positive | Negative | Positive | Negative | Positive | Negative | ||
| 0ng/mL | Negative | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.25ng/mL | -75% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.5ng/mL | -50% cutoff | 60 | 0 | 60 | 0 | 60 | 0 | 60 |
| 0.75ng/mL | -25% cutoff | 60 | 4 | 56 | 2 | 58 | 2 | 58 |
| lng/mL | cutoff | 60 | 34 | 26 | 34 | 26 | 36 | 24 |
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| 1.25ng/mL | +25% cutoff | 60 | 56 | 4 | 58 | 2 | 56 | 4 |
|---|---|---|---|---|---|---|---|---|
| 1.5ng/mL | +50% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 1.75ng/mL | +75% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
| 2ng/mL | +100% cutoff | 60 | 60 | 0 | 60 | 0 | 60 | 0 |
b. Linearity/assay reportable range:
Not applicable. This device is intended for qualitative use only.
c. Stability:
The device is stable at 2-30°C for 24 months based on real time stability study.
d. Analytical specificity/Interference:
The following table lists the lowest concentration (ng/mL) of compounds that gave a positive result on the Dochek® Fentanyl Urine Test identified positive results.
| Compound | Lowest Concentration(ng/mL) | % Cross-Reactivity |
|---|---|---|
| Acetyl fentanyl | 1.0 | 100 |
| Acetyl norfentanyl | 10,000 | 0.01 |
| Acrylfentanyl | 1.5 | 66.7 |
| Butyryl fentanyl | 2.5 | 40 |
| 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 |
| (±) ß-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 |
| Despropionyl fentanyl (4-ANPP) | 20,000 | 0.005 |
| Remifentanil | 10,000 | 0.01 |
| Norcarfentanil | 10,000 | 0.01 |
| Norfentanyl | 10,000 | 0.01 |
e. Interference
Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine or drug positive urine containing Fentanyl with the concentration 50% below the cutoff and the concentration 50% above the cutoff, respectively. All potential interfering substances were added at a concentration of 100µg/mL or specified concentrations are summarized in the following tables. The urine specimens were tested with 3 lots of Dochek® Fentanyl Urine Test. None of the substances listed below were shown to interfere.
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Opioids compounds
| 6-Acetyl morphine | Amphetamine | Buprenorphine | Buprenorphineglucuronide |
|---|---|---|---|
| Codeine | Dextromethorphan | Dihydrocodeine | EDDP |
| EMDP | Fluoxetine | Heroin | Hydrocodone |
| Hydromorphone | Ketamine, | Levorphanol | Meperidine |
| Methadone | Morphine | Morphine-3-glucuronide | Naloxone |
| Naltrexone | Norbuprenorphine | Norcodeine | Norketamine |
| Normeperidine | Normorphine | Noroxycodone | Oxycodone |
| Oxymorphone | Pentazocine (Talwin) | Pipamperone | Risperidone |
| Tapentadol | Thioridazine | Tilidine | Tramadol |
| Tramadol-O-Desmethyl | Tramadol-N-Desmethyl | Trazodone |
Commonly ingested medications or substances
| Acetaminophen | Doxepin (50 ug/mL) | Nortriptyline (25 ug/mL) |
|---|---|---|
| Acetone (1000 mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Erythromycin | Octopamine |
| Albumin (100 mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline (35 ug/mL) | Furosemide | Oxymetazoline |
| Amobarbital | Galactose (10 mg/dL) | Papaverine |
| Amoxicillin | Gamma Globulin (500mg/dL) | Penicillin G |
| Ampicillin | Gentisic acid | Perphenazine |
| Apomorphine | Glucose (3000 mg/dL) | Phencyclidine |
| Ascorbic acid | Hemoglobin | Phenelzine |
| Aspartame | DL-Tyrosine | Prednisone |
| Atropine | Hydralazine | Propoxyphene (50 ug/mL) |
| Benzilic acid | Hydrochlorothiazide | Propranolol |
| Benzoic acid | Hydrocortisone | Pseudoephedrine |
| Benzoylecgonine | Hydroxytyramine | Quinine |
| Bilirubin | Ibuprofen | Ranitidine |
| Boric Acid (1%) | Imipramine (30 ug/mL) | Riboflavin (7.5 mg/dL) |
| Bupropion (50 ug/mL) | Isoproterenol | Salicylic acid |
| Caffeine | Isoxsuprine | Secobarbital |
| Carbamazepine | Ketoprofen | Serotonin (5-Hydroxytyramine) |
| Chloral hydrate | Labetalol | Sulfamethazine |
| Chloramphenicol | Lidocaine (50 ug/mL) | Sulindac |
| Chlorothiazide | Loperamide | Tetrahydrocortisone 3-(ß-Dglucuronide) |
| Chlorpromazine | Maprotiline (50 ug/mL) | Tetrahydrocortisone 3-acetate |
| Cholesterol | Meprobamate | Tetrahydrozoline |
| Clomipramine (50 ug/mL) | Methapyrilene (10 ug/mL) | Thiamine |
| Clonidine | Methaqualone (50 ug/mL) | Triamterene |
| Cortisone | Methoxyphenamine | Trifluoperazine |
| Cotinine | Metronidazole (300 ug/mL) | Trimethoprim |
| Creatinine | N-Acetylprocainamide | Tyramine |
| Cyclobenzaprine (10 ug/mL) | NaCl (4000 mg/dL) | Urea (2000 mg/dL) |
| Deoxycorticosterone | Nalidixic acid | Uric acid |
| Desipramine (50 ug/mL) | Naproxen | Valproic acid (250 ug/mL) |
| Diclofenac | Niacinamide | Venlafaxine |
| Diflunisal | Nicotine (10 ug/mL) | Verapamil |
| Digoxin | Nifedipine | Zomepirac |
| Diphenhydramine | Norethindrone | ß-Estradiol |
| DL-Tryptophan | Phenobarbital |
B. Method comparison study
80 clinical urine specimens were analyzed by LC/MS and by 3 lots of the corresponding Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Card and Dochek® Fentanyl Urine Test Cup. Samples were
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divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. The study was conducted by 3 laboratory professionals at the manufacturer site. Results were as follows.
| Dochek® Fentanyl Urine TestStrip | LC/MS | Agreement Rate | |||||
|---|---|---|---|---|---|---|---|
| Neg.(drug free) | Neg.(<-50%cutoff) | Near cutoff neg.(-50% cutoff tocutoff) | Near cutoff pos.(cutoff to +50%cutoff) | Pos.(>+50%cutoff) | |||
| Lot 1, operator 1 | Positive | 0 | 0 | 1 | |||
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 2, operator 2 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 3, operator 3 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) |
Comparison data of Dochek® Fentanyl Urine Test Strip
Analysis of Discordant Results (Strip)
| Dochek® Fentanyl Urine Test Strip | LC/MS Analysis | ||
|---|---|---|---|
| Lot No. and Operator | Test Result | Concentration range | Fentanyl Concentration(ng/mL) |
| Lot 1, operator 1 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.945 |
| Lot 1, operator 1 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.012 |
| Lot 2, operator 2 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.894 |
| Lot 2, operator 2 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.012 |
| Lot 3, operator 3 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.920 |
| Lot 3, operator 3 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.077 |
Comparison data of Dochek® Fentanyl Urine Test Card
| LC/MS | |||||||
|---|---|---|---|---|---|---|---|
| Dochek® Fentanyl Urine TestCard | Neg.(drugfree) | Neg.(<-50%cutoff) | Near cutoff neg.(-50% cutoff tocutoff) | Near cutoff pos.(cutoff to +50%cutoff) | Pos.(>+50%cutoff) | Agreement Rate | |
| Lot 1, operator 1 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 2, operator 2 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 3, operator 3 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) |
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| Dochek® Fentanyl Urine Test Card | LC/MS Analysis | ||
|---|---|---|---|
| Lot No. and Operator | Test Result | Concentration range | Fentanyl Concentration(ng/mL) |
| Lot 1, operator 1 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.885 |
| Lot 1, operator 1 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.012 |
| Lot 2, operator 2 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.894 |
| Lot 2, operator 2 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.020 |
| Lot 3, operator 3 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.945 |
| Lot 3, operator 3 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.012 |
Comparison data of Dochek® Fentanyl Urine Test Cup
| Dochek® Fentanyl Urine TestCup | LC/MS | Agreement Rate | |||||
|---|---|---|---|---|---|---|---|
| Neg.(drug free) | Neg.(<-50%cutoff) | Near cutoff neg.(-50% cutoff tocutoff) | Near cutoff pos.(cutoff to +50%cutoff) | Pos.(>+50%cutoff) | |||
| Lot 1, operator 1 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 2, operator 2 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) | |
| Lot 3, operator 3 | Positive | 0 | 0 | 1 | 26 | 13 | 97.5%(87.1%-99.6%) |
| Negative | 10 | 14 | 15 | 1 | 0 | 97.5%(87.1%-99.6%) |
Analysis of Discordant Results (Cup)
| Dochek® Fentanyl Urine Test Cup | LC/MS Analysis | ||
|---|---|---|---|
| Lot No. and Operator | Test Result | Concentration range | Fentanyl Concentration(ng/mL) |
| Lot 1, operator 1 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.894 |
| Lot 1, operator 1 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.044 |
| Lot 2, operator 2 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.945 |
| Lot 2, operator 2 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.044 |
| Lot 3, operator 3 | Positive | Near cutoff neg. (-50% cutoff to cutoff) | 0.920 |
| Lot 3, operator 3 | Negative | Near cutoff pos. (cutoff to +50% cutoff) | 1.012 |
C. Lay person study
Lay user studies were performed at three intended user sites with 980 lay persons. They had diverse educational and professional backgrounds and ranged in age from 20 to 65 years. Urine samples were prepared at the following concentrations: 0ng/mL, 0.25 ng/mL, 0.75ng/mL, 1.25ng/mL, 1.5ng/mL, 1.5ng/mL, 1.75ng/mL, cutoff by spiking target drug fentanyl into drug free urine specimens. The concentrations of samples were confirmed by
{15}------------------------------------------------
LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized. Each participant was provided with the English package insert, 1 blind labeled sample, and a device. Results were as follows:
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| Positive | Negative | ||||
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75% cutoff | 40 | 0 | 40 | 100% |
| 0.5ng/mL | -50% cutoff | 40 | 0 | 40 | 100% |
| 0.75ng/mL | -25% cutoff | 40 | 2 | 38 | 95% |
| 1.25ng/mL | +25% cutoff | 40 | 38 | 2 | 95% |
| 1.5ng/mL | +50% cutoff | 40 | 40 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 40 | 40 | 0 | 100% |
Lay user study data of Dochek® Fentanyl Urine Test Strip
Lay user study data of Dochek® Fentanyl Urine Test Card (cassette method)
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| Positive | Negative | ||||
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75% cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50% cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25% cutoff | 30 | 1 | 29 | 96.7% |
| 1.25ng/mL | +25% cutoff | 30 | 28 | 2 | 93.3% |
| 1.5ng/mL | +50% cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 30 | 30 | 0 | 100% |
Lay user study data of Dochek® Fentanyl Urine Test Card (dipcard method)
| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| Positive | Negative | ||||
| 0ng/mL | Negative | 30 | 0 | 30 | 100% |
| 0.25ng/mL | -75% cutoff | 30 | 0 | 30 | 100% |
| 0.5ng/mL | -50% cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/mL | -25% cutoff | 30 | 2 | 28 | 93.3% |
| 1.25ng/mL | +25% cutoff | 30 | 29 | 1 | 96.7% |
| 1.5ng/mL | +50% cutoff | 30 | 30 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 30 | 30 | 0 | 100% |
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| Approximateconcentrationof sample | % of cutoff | Number ofdeterminationsper lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| Positive | Negative | ||||
| 0ng/mL | Negative | 40 | 0 | 40 | 100% |
| 0.25ng/mL | -75% cutoff | 40 | 0 | 40 | 100% |
| 0.5ng/mL | -50% cutoff | 40 | 0 | 40 | 100% |
| 0.75ng/mL | -25% cutoff | 40 | 3 | 37 | 92.5% |
| 1.25ng/mL | +25% cutoff | 40 | 37 | 3 | 92.5% |
| 1.5ng/mL | +50% cutoff | 40 | 40 | 0 | 100% |
| 1.75ng/mL | +75% cutoff | 40 | 40 | 0 | 100% |
Lay user study data of Dochek® Fentanyl Urine Test Cup
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 a substantial equivalence decision.
§ 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).