(30 days)
Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. 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. Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL. For in vitro diagnostic use only. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred confirmatory method.
Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument. Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
The provided text describes a 510(k) premarket notification for a Rapid Urine Fentanyl (FYL) Test Strip and Dipcard. The device is a rapid screening test for the qualitative detection of Fentanyl in human urine at a cut-off concentration of 1 ng/mL. The approval is an addition of an OTC (Over-The-Counter) claim to a previously cleared prescription device (K231904).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" as a separate table. However, the performance is demonstrated through a lay user study, with the implicit acceptance being a high agreement with the confirmed sample concentrations.
| Sample Concentration (ng/mL) | % of Cutoff | Lay User Agreement (Test Strip) | Lay User Agreement (Test Dipcard) |
|---|---|---|---|
| 0 | Negative | 100% | 100% |
| 0.5 | -50% cutoff | 100% | 100% |
| 0.75 | -25% cutoff | 93% (2 Positive, 28 Negative) | 97% (1 Positive, 29 Negative) |
| 1.25 | +25% cutoff | 97% (29 Positive, 1 Negative) | 90% (27 Positive, 3 Negative) |
| 1.5 | +50% cutoff | 100% (30 Positive, 0 Negative) | 100% (30 Positive, 0 Negative) |
| 2 | +100% cutoff | 100% (30 Positive, 0 Negative) | 100% (30 Positive, 0 Negative) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The lay user study used 360 lay persons. For each device (Test Strip and Test Dipcard) and each concentration level, 30 determinations were made.
- Data Provenance: The text does not explicitly state the country of origin. The study was conducted at "three intended user sites." The study design indicates it was a prospective study where participants tested blinded, randomized samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The text states: "The concentrations of samples were confirmed by LC/MS." It does not specify the number of experts or their qualifications for this confirmation. LC/MS (Liquid Chromatography-Mass Spectrometry) is an analytical chemistry technique, and its use implies that the ground truth was established through a laboratory method, likely performed by trained laboratory personnel.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The text does not mention an adjudication method for the lay user results. Each participant's interpretation of their test result was recorded, and the "Agreement (%)" was calculated based on these individual interpretations compared to the known sample concentration.
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
This section is not applicable as the device is a rapid, screening test for drug detection and does not involve AI or human reader interpretation in the context of image analysis or diagnostic assistance. The "readers" in this case are the lay users interpreting the test strip/dipcard result.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a manual, rapid test. The "standalone" performance is essentially what the lay users demonstrated in their interpretation of the test results themselves. There is no algorithm or automated reading discussed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the test set samples was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is a highly specific and sensitive analytical chemical method for confirming the concentration of substances. The text explicitly states: "The concentrations of samples were confirmed by LC/MS."
8. The sample size for the training set
The document does not provide information about a "training set" for the device itself because it is an immunochromatographic assay, not an AI/machine learning device. The performance characteristics are inherent to the chemical formulation and manufacturing procedures. The 510(k) summary references "analytical performance in predicate K231904" and "studies in predicate K231904," which would include the foundational analytical performance data.
9. How the ground truth for the training set was established
As there is no "training set" in the context of AI/machine learning, this question is not applicable. The analytical performance and design of this type of device are established through various laboratory studies (e.g., specificity, sensitivity, precision, cross-reactivity) using reference standards and confirmed samples, as would have been documented for the predicate device (K231904).
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Image /page/0/Picture/0 description: The image shows 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.
Co-Innovation Biotech Co.,Ltd. Hong Feng Product Manager No.9 Baihe 3 Street, Economic And Technological Development East Zone Guangzhou, 510530, Guangdong P.R. China
Re: K241100
Trade/Device Name: Rapid Urine Fentanyl (FYL) Test Strip: Rapid Urine Fentanyl (FYL) Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL Dated: April 22, 2024 Received: April 22, 2024
Dear Hong Feng:
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.
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).
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2
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 OS 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A.
Kotarek -S
Digitally signed by Joseph A.
Kotarek -S
Date: 2024.05.22 12:02:56 -04'00"
Joseph Kotarek 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
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Indications for Use
510(k) Number (if known) K241100
Device Name
Rapid Urine Fentanyl (FYL) Test Strip Rapid Urine Fentanyl (FYL) Test Dipcard
Indications for Use (Describe)
Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
This assay provides only a preliminary analytical test result. 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.
Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. GC/MS is the preferred 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)
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Section 5 - 510(k) Summary
Date of Summary Preparation: May 22, 2024 510 (K) number:K241100
1. Submitter's Identifications
Submitter: Co-Innovation Biotech Co., Ltd. Address: No.9 Baihe 3 Street, Economic And Technological Development East Zone , Guangzhou,510530, Guangdong P.R. CHINA Contact Person: Hong Feng Contact Email Address: fenghongfda@126.com Telephone: + 86 -20-82109823 Fax: + 86 -20-82109823
2. Correspondent's Identifications
Correspondent's Name: Co-Innovation Biotech Co., Ltd. Address: No.9 Baihe 3 Street, Economic And Technological Development East Zone , Guangzhou,510530, Guangdong P.R. CHINA Contact Person: Hong Feng Contact Email Address: fenghongfda(@126.com Telephone: + 86 -20-82109823 Fax: + 86 -20-82109823
3. Name of the Device
Recommended classification regulation:
21 CFR 862.3650 Opiate test system
Device class: ClassII Panel: Toxicology (91) Product code: NGL Common Name:
Fentanyl (FYL) Test System
Proprietary names:
Rapid Urine Fentanyl (FYL) Test Strip Rapid Urine Fentanyl (FYL) Test Dipcard
4. The Predicate Devices
- K231904 Rapid Fentanyl (FYL) Test Strip Rapid Fentanyl (FYL) Test Dipcard
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5. Device Description
Rapid Urine Fentanyl (FYL) Test Strip and Rapid Urine Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl at or above the cut-off concentration of 1 ng/mL. The tests can be performed without the use of an instrument.
Test Strip and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.
6. Intended Use of Device
Rapid Urine Fentanyl (FYL) Test Strip is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
This assay provides only a preliminary analytical test result. 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.
Rapid Urine Fentanyl (FYL) Test Dipcard is a rapid, screening test for the qualitative detection of Fentanyl (FYL) in human urine at the cut-off concentration of 1 ng/mL.
For in vitro diagnostic use only.
This assay provides only a preliminary analytical test result. 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.
7. Substantial Equivalence Information:
A summary comparison of features of Rapid Urine Fentanyl (FYL) Test Strip, Rapid Urine Fentanyl (FYL) Test Dipcard and the predicate devices is provided in the following Table:
| Item | Device | Predicate (K231904) |
|---|---|---|
| Indication for use | Qualitative detection of fentanyl in urine | Same |
| Intended Use | Over-The-Counter Use | Prescription Use |
| Specimen | Urine | Same |
| Cutoff | 1 ng/mL | Same |
| Results | Qualitative | Same |
| Methodology | Competitive binding, Lateral flowimmunochromatographic assay basedon the principle of antigen antibody | Same |
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| immunochemistry | ||
|---|---|---|
| Configuration | Strip and Dipcard | Same |
| Platform Required | No | Same |
| Storage | 4-30°C | Same |
Remark:
The subject devices have all features of the predicate device except Intended Use.
8. Performance Characteristics:
8.1 Analytical Performance Clearance of candidate device is for addition of OTC claim. See analytical performance in predicate K231904.
8.2 Comparison Studies See studies in predicate K231904.
8.3 Lay User Study
A lay user study was performed at three intended user sites with 360 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to 65 years. Urine samples were prepared at the following concentrations: 0, +/- 50% cutoff, +/- 25% cutoff and +100% cutoff by spiking target drug fentanyl into drug free urine specimens. The concentrations of samples were confirmed by 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 ofdeterminations per lot | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| 0ng/ml | Negative | 30 | 0 | 30 | 100% |
| 0.5ng/ml | -50%cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/ml | -25%cutoff | 30 | 2 | 28 | 93% |
| 1.25ng/ml | +25%cutoff | 30 | 29 | 1 | 97% |
| 1.5ng/ml | +50%cutoff | 30 | 30 | 0 | 100% |
| 2ng/ml | +100%cutoff | 30 | 30 | 0 | 100% |
Rapid Urine Fentanyl (FYL) Test Strip:
Rapid Urine Fentanyl (FYL) Test Dipcard:
| Approximateconcentration | % of cutoff | Number ofdeterminations | Layer user Results | Agreement(%) | |
|---|---|---|---|---|---|
| Positive | Negative |
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| of sample | ons per lot | ||||
|---|---|---|---|---|---|
| 0ng/ml | Negative | 30 | 0 | 30 | 100% |
| 0.5ng/ml | -50%cutoff | 30 | 0 | 30 | 100% |
| 0.75ng/ml | -25%cutoff | 30 | 1 | 29 | 97% |
| 1.25ng/ml | +25%cutoff | 30 | 27 | 3 | 90% |
| 1.5ng/ml | +50%cutoff | 30 | 30 | 0 | 100% |
| 2ng/ml | +100%cutoff | 30 | 30 | 0 | 100% |
9. Conclusion:
Based on the test principle and performance characteristics of the device, it's concluded that Rapid Urine Fentanyl (FYL) Test is substantially equivalent to the predicate
§ 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).