(254 days)
The Rapid 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.
The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The Rapid 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.
The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
Rapid Fentanyl (FYL) Test Strip and Rapid 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 document describes the Co-Innovation Biotech Co.,Ltd. Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard, which are rapid screening tests for the qualitative detection of Fentanyl (FYL) in human urine at a cut-off concentration of 1 ng/mL. The document includes performance data to demonstrate substantial equivalence to a predicate device (K220046 Superbio Fentanyl Urine Detection Kit).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" with numerical targets for accuracy, sensitivity, or specificity. However, the precision study and accuracy study demonstrate performance relative to the cut-off concentration. The implied acceptance criteria are that the device should accurately detect fentanyl around the 1 ng/mL cut-off and exhibit minimal interference and cross-reactivity. The precision study illustrates the device's ability to classify samples correctly relative to the cut-off, and the accuracy study compares device results to LC/MS reference results.
| Performance Metric | Implied Acceptance Criteria (Based on typical drug screening test expectations) | Reported Device Performance (Rapid Fentanyl (FYL) Test Strip and Dipcard - data presented is identical for both) |
|---|---|---|
| Precision | Consistent results for samples below, at, and above the cut-off. | Rapid Fentanyl (FYL) Test Strip: - 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot). - 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 4/60 (Lot 2), 2/60 (Lot 3) positive results (majority negative). - 1 ng/mL (cutoff): 34/60 (Lot 1), 34/60 (Lot 2), 36/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff). - 1.25 ng/mL (+25% cutoff): 56/60 (Lot 1), 58/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive). - 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot).Rapid Fentanyl (FYL) Test Dipcard: - 0 ng/mL, 0.25 ng/mL, 0.5 ng/mL: 100% negative (60/60 for each lot). - 0.75 ng/mL (-25% cutoff): 4/60 (Lot 1), 2/60 (Lot 2), 6/60 (Lot 3) positive results (majority negative). - 1 ng/mL (cutoff): 36/60 (Lot 1), 34/60 (Lot 2), 32/60 (Lot 3) positive results (near 50% positive/negative as expected at cutoff). - 1.25 ng/mL (+25% cutoff): 54/60 (Lot 1), 56/60 (Lot 2), 56/60 (Lot 3) positive results (majority positive). - 1.5 ng/mL, 1.75 ng/mL, 2 ng/mL: 100% positive (60/60 for each lot). |
| Accuracy (Agreement with Reference Method) | High agreement with a confirmed analytical method (LC/MS). | Rapid Fentanyl (FYL) Test Strip & Dipcard: - Discordant results for both devices and all sites: One positive at 0.76 ng/mL (LC/MS result, below cutoff) and one negative at 1.04 ng/mL (LC/MS result, above cutoff). - Drug-free: 27/27 negative calls by device. - Less than half cutoff: 5/5 negative calls by device. - Near Cutoff Negative (0.5-1 ng/mL): 7/8 negative calls by device, 1/8 positive call (at 0.76ng/mL). - Near Cutoff Positive (1-1.5 ng/mL): 8/9 positive calls by device, 1/9 negative call (at 1.04ng/mL). - High Positive (>1.5 ng/mL): 31/31 positive calls by device. |
| Cross-reactivity | Minimal cross-reactivity with structurally similar compounds. | Fentanyl analogs showed varying degrees of cross-reactivity, some as low as 1.2 ng/mL (Acetyl fentanyl), while Norfentanyl and Acetyl norfentanyl showed very low (0.01%) cross-reactivity at 10,000 ng/mL. This indicates the device can detect some fentanyl analogs at relevant concentrations. |
| Interference | No interference from common opioids, medications, or endogenous substances. | None of the tested opioids, commonly ingested medications, or substances (at specified concentrations) were shown to interfere with the test. |
| Effect of urinary pH | Consistent results across a range of urinary pH. | Varying ranges of pH (3 to 9) did not interfere with performance. |
| Effect of urinary specific gravity | Consistent results across a range of urinary specific gravity. | Varying ranges of urinary specific gravity (1.000 to 1.040) did not affect the test result. |
2. Sample Size and Data Provenance for the Test Set:
- Precision Study (Test Set):
- Sample Size: 1620 observations in total (3 lots x 9 concentrations x 60 determinations/lot for each device type). Each concentration tested in 3 replicates daily for 10 non-consecutive days with 3 aliquots per location (2 operators per location, 3 locations).
- Data Provenance: Drug-free human urine spiked with target fentanyl at various concentrations. The document does not specify the country of origin but implies laboratory-controlled samples, not patient data. Retrospective, as urine samples were collected and then spiked.
- Accuracy Study (Test Set):
- Sample Size: 80 clinical urine specimens.
- Data Provenance: Clinical urine specimens. The country of origin is not specified. Retrospective.
3. Number of Experts (or Reference Method) and Qualifications to Establish Ground Truth for the Test Set:
- Precision Study: Ground truth was established by precise spiking of fentanyl into drug-free urine at known concentrations, confirmed by LC/MS. No human experts were involved in establishing the ground truth for these spiked samples, as the concentration was analytically determined.
- Accuracy Study: Ground truth was established by LC/MS (Gas Chromatography/ Mass spectrometry or Liquid chromatography/Mass spectrometry) analysis of the clinical urine specimens. LC/MS is the "preferred confirmatory method" and considered the gold standard for quantitative drug testing. The qualifications of the LC/MS operators or analysts are not specified.
4. Adjudication Method for the Test Set:
Not applicable in the conventional sense of expert adjudication.
- In the precision study, known concentrations (LC/MS confirmed) served as the reference.
- In the accuracy study, LC/MS served as the reference method. Discordant results were analyzed by comparing the device's reading to the objective LC/MS concentration around the cutoff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done in the context of human readers improving with AI vs. without AI assistance. This device is a rapid, screening test (immunochromatographic assay) and is not an AI-powered diagnostic imaging or interpretative device that augments human reader performance.
- However, the precision study did involve multiple operators (6 operators at 3 Point-of-Care sites) reading the results, although it wasn't designed as a comparative effectiveness study of human reader improvement. Each operator independently read the samples.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- Yes, this device is a standalone test. The "Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of fentanyl... The tests can be performed without the use of an instrument." The results are visually interpreted by a human operator, but the device itself does not involve an algorithm or AI. It functions as a direct chemical/immunological reaction.
7. Type of Ground Truth Used:
- Precision Study: Known concentrations of Fentanyl in urine, confirmed by LC/MS.
- Accuracy Study: Quantitative results from LC/MS analysis of clinical urine specimens.
8. Sample Size for the Training Set:
This information is typically not applicable or explicitly stated for rapid, immunoassay-based tests like the one described. These devices are developed through chemical and biological formulation and optimization rather than machine learning training on a "training set" of data. The document describes analytical validation studies, which are performance evaluations, not algorithm training.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the context of an AI/ML algorithm for this type of immunochromatographic device. The development process would involve optimizing reagent concentrations, membrane properties, and other manufacturing parameters to achieve the desired sensitivity and specificity, typically guided by analytical testing against known standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
Co-Innovation Biotech Co.,Ltd. Hong Feng Product Manager No.9 Baihe 3 Street, Economic And Technological Development East Zone, Guangzhou. Guangdong 510530 China
Re: K231904
Trade/Device Name: Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG Dated: February 2, 2024 Received: February 2, 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).
{1}------------------------------------------------
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
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
| Digitally signed by Joseph A. Kotarek -S |
|---|
| Date: 2024.03.08 11:37:33 |
| -05'00' |
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Indications for Use
510(k) Number (if known) K231904
Device Name Rapid Fentanyl (FYL) Test Strip Rapid Fentanyl (FYL) Test Dipcard
Indications for Use (Describe)
The Rapid 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.
The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The Rapid 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.
The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
| 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) |
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Section 5 - 510(k) Summary
Date of Summary Preparation: March 6, 2024 510 (K) number:K231904
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: DJG Common Name:
Fentanyl (FYL) Test System
Proprietary names:
Rapid Fentanyl (FYL) Test Strip Rapid Fentanyl (FYL) Test Dipcard
4. The Predicate Devices
K220046 Superbio Fentanyl Urine Detection Kit
5. Device Description
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Rapid Fentanyl (FYL) Test Strip and Rapid 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
The Rapid 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.
The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
The Rapid 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. The tests is intended for in vitro diagnostics use. It is intended for prescription use including point of care sites. This assay provides only a preliminary analytical test result. To obtain a confirmed analytical result, a more specific alternative chemical method must be used. Gas Chromatography/ Mass spectrometry (GC/MS) or Liquid chromatography/Mass spectrometry (LC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.
7. Comparison to Predicate Devices:
A summary comparison of features of the Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard and the predicate devices is provided in the following Table:
| Item | Device | Predicate (K220046) |
|---|---|---|
| Indication for use | Qualitative detection of fentanyl in urine | Same |
| Intended Users | Prescription Use | Same |
| Specimen | Urine | Same |
| Cutoff | 1 ng/mL | Same |
| Results | Qualitative | Same |
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| Methodology | Competitive binding, Lateral flowimmunochromatographic assay basedon the principle of antigen antibodyimmunochemistry | Same |
|---|---|---|
| Configuration | Strip and Dipcard | Same |
| Platform Required | No | Immunofluorescence Analyzer |
| Storage | 4-30°C | Same |
Remark:
The subject devices have all features of the predicate device except Platform Required.
8. Performance Data:
8.1 Cross-reactivity with structurally similar compounds
To test the cross reactivity of the test, 3 lots of test Strip and test Dipcard was used to test with drug metabolites and drug structurally similar compounds in urine. All the components were added to drug-free normal human urine. Each sample was tested in 3 replicates using 3 lots of Strip and test Dipcard. If any positive result was observed, the compounds were further diluted with known drug-free urine specimen sequentially to different concentrations and tested in quintuplicate, until the highest concentration that generates a negative result was identified. The cross reacting substances with the lowest concentration that produced a positive result was identified and is listed in the table below.
| Compound | LowestConcentration(ng/mL) | %Cross-reactivity |
|---|---|---|
| Norfentanyl | 10,000 | 0.01 |
| Acetyl fentanyl | 1.2 | 83.3 |
| Acetyl norfentanyl | 10,000 | 0.01 |
| Acrylfentanyl | 1.5 | 66.7 |
| Butyryl fentanyl | 1.6 | 62.5 |
| Carfentanil | 500 | 0.2 |
| (±)-3-cis-methylfentanyl | 5 | 20 |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.3 |
| Furanyl fentanyl | 1.8 | 55.6 |
| ω-1-Hydroxyfentanyl | 20,000 | 0.01 |
| (±) β-hydroxythiofentanyl | 2.8 | 35.7 |
| Isobutyryl fentanyl | 1.5 | 66.7 |
| Ocfentanil | 1.8 | 55.6 |
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| Para-fluorobutyrylfentanyl(p-FBF) | 3 | 33.3 |
|---|---|---|
| Para-fluoro fentanyl | 3 | 33.3 |
| Sufentanil | 625 | 0.16 |
| Valeryl fentanyl | 2.5 | 40 |
8.2 Interference
Clinical urine samples may contain substances that could potentially interfere with the test. The following compounds were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. All potential interfering substances were added at a concentration of 100µg/mL (despropionyl fentanyl (4-ANPP) at 50 ug/mL, norcarfentanil at 5 ug/mL and remifentanil at 10 ug/ mL) or specified concentrations are summarized in the following tables. The urine specimens were tested with 3 lots of test Strip and test Dipcard. None of the compounds listed below were shown to interfere.
Opioids compounds
| 6-Acetyl morphine | EDDP | Methadone | Normeperidine | Tapentadol |
|---|---|---|---|---|
| Alfentanil | EMDP | Morphine | Normorphine | Thioridazine |
| Amphetamine | Fluoxetine | Morphine-3-glucuronide | Noroxycodone | Tilidine |
| Buprenorphine | Heroin | Naloxone | Oxycodone | Tramadol |
| Buprenorphineglucuronide | Hydrocodone | Naltrexone | Oxymorphone | Tramadol-O-Desmethyl |
| Codeine | Hydromorphone | Norbuprenorphine | Pentazocine(Talwin) | Tramadol-N-Desmethyl |
| Despropionylfentanyl (4-ANPP)(50ug/mL) | Ketamine | Norcarfentanil(5ug/mL) | Pipamperone | Trazodone |
| Dextromethorphan | Levorphanol | Norcodeine | Remifentanil(10ug/mL) | |
| Dihydrocodeine | Meperidine | Norketamine | Risperidone |
Commonly ingested medications or substances
| Acetaminophen | Doxepin (50ug/ml) | Nortriptyline (25ug/ml) |
|---|---|---|
| Acetone (1000mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Erythromycin | Octopamine |
| Albumin (100mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline (35ug/ml) | Furosemide | Oxymetazoline |
| Amobarbital | Galactose (10mg/dL) | Papaverine |
| Amoxicillin | Gamma Globulin(500mg/dL) | Penicillin G |
| Ampicillin | Gentisic acid | Perphenazine |
| Apomorphine | Glucose (3000mg/dL) | Phencyclidine |
| Ascorbic acid | Hemoglobin | Phenelzine |
| Aspartame | Hydralazine | Phenobarbital |
| Atropine | Hydrochlorothiazide | Prednisone |
| Benzilic acid | Hydrocortisone | Propoxyphene (50ug/ml) |
| Benzoic acid | Hydroxytyramine | Propranolol |
| Benzoylecgonine | Ibuprofen | Pseudoephedrine |
| Bilirubin | Imipramine (30ug/ml) | Quinine |
| Boric Acid (1%) | Isoproterenol | Ranitidine |
| Bupropion (50ug/ml) | Isoxsuprine | Riboflavin (7.5mg/dL) |
| Caffeine | Ketamine | Salicylic acid |
| Carbamazepine | Ketoprofen | Secobarbital |
| Chloral hydrate | Labetalol | Serotonin(5-Hydroxytyramine) |
| Chloramphenicol | Lidocaine (50ug/ml) | Sulfamethazine |
| Chlorothiazide | Loperamide | Sulindac |
| Chlorpromazine | Maprotiline (50ug/ml) | Tetrahydrocortisone3-(β-Dglucuronide) |
| Cholesterol | Meperidine | Tetrahydrocortisone 3-acetate |
| Clomipramine (50ug/ml) | Meprobamate | Tetrahydrozoline |
| Clonidine | Methapyrilene (10ug/ml) | Thiamine |
| Cortisone | Methaqualone (50ug/ml) | Thioridazine |
| Cotinine | Methoxyphenamine | Triamterene |
| Creatinine | Metronidazole (300ug/ml) | Trifluoperazine |
| Cyclobenzaprine(10ug/ml) | N-Acetylprocainamide | Trimethoprim |
| Deoxycorticosterone | NaCl (4000mg/dL) | Tyramine |
| Desipramine (50ug/ml) | Nalidixic acid | Urea (2000mg/dL) |
| Dextromethorphan | Naloxone | Uric acid |
| Diclofenac | Naltrexone | Valproic acid (250ug/ml) |
| Diflunisal | Naproxen | Venlafaxine |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine (10ug/ml) | Zomepirac |
| DL-Tryptophan | Nifedipine | β-Estradiol |
| DL-Tyrosine | Norethindrone |
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8.3 Effect of urinary pH
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The pH of an aliquot negative urine pool is adjusted to a pH range of 3 to 9 in 1 pH unit increments and spiked with target fentanyl at 50% below and 50% above cutoff levels. Each sample was tested by 3 lots of test Strip and test Dipcard. The results demonstrate that varying ranges of pH do not interfere with the performance of the test.
8.4 Effect of Urinary specific gravity
The specific gravity studies were conducted on different specific gravity including 1.000,1.010, 1.020, 1.030, 1.040 specimens and spiked with target drug fentanyl with concentrations at 50% below and 50% above Cut-Off levels. Each sample was tested by 3 lots of test Strip and test Dipcard. The results demonstrate that varying ranges of urinary specific gravity do not affect the test result.
8.5 Precision
Precision studies were performed using 3 lots of test Strip and test Dipcard. Drug free specimens were spiked with target drug fentanyl at 0, ±75% cutoff, ±25% cutoff and +100% cutoff of drug. The concentrations of the target drugs were confirmed with LC/MS. Each concentration of the urine specimen was divided into aliquot was blindly labeled by a nonparticipant. Separate sets of blinded coded samples were assigned and randomized prior to testing. The study was conducted by 6 operators at 3 Point-of-Care sites. Two operators per location tested 3 aliquots at each concentration for each lot per day (3 runs/day) for 10 non-consecutive days using one device lot per location. One operator tested the test strip format and the second operator test dipcard format. There were 1620 observations by 3 sites at 9 concentrations.
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations perlot | Result | 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 | 4 | 56 | 2 | 58 | 6 | 54 | ||
| 1ng/ml | cutoff | 60 | 36 | 24 | 34 | 26 | 32 | 28 | ||
| 1.25ng/ml | +25%cutoff | 60 | 54 | 6 | 56 | 4 | 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 |
Rapid Fentanyl (FYL) Test Strip:
{9}------------------------------------------------
| Approximateconcentration of sample | % of cutoff | Number ofdeterminations per lot | Result | 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 | 4 | 56 | 4 | 56 | 2 | 58 | ||
| 1ng/ml | cutoff | 60 | 34 | 26 | 34 | 26 | 36 | 24 | ||
| 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 |
Rapid Fentanyl (FYL) Test Dipcard:
8.6 Accuracy
80 clinical urine specimens were analyzed by LC/MS and by 3 lots of Rapid Fentanyl (FYL) Test Strip and Rapid Fentanyl (FYL) Test Dipcard. Samples were divided by concentration into five categories: drug free, less than half the cutoff negative, near cutoff positive, and high positive. Results were as follows:
Rapid Fentanyl (FYL) Test Strip:
| Operator | Co-InnovationResult | Drugfree byLC/MSanalysis | Less thanhalf thecutoffconcentrationby LC/MSanalysis | Near CutoffNegative(Between50% belowthe cutoff andthe cutoffconcentration) | Near CutoffPositive(Between thecutoff and50% abovethe cutoffconcentration) | High Positive(greater than50% abovethe cutoffconcentration) | Total |
|---|---|---|---|---|---|---|---|
| Site1 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Negative | 27 | 5 | 7 | 1 | 0 | ||
| Site2 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Negative | 27 | 5 | 7 | 1 | 0 | ||
| Site3 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Negative | 27 | 5 | 7 | 1 | 0 |
Analysis of Discordant Results Rapid Fentanyl (FYL) Test Strip
{10}------------------------------------------------
| Rapid Fentanyl (FYL) Test Strip | LC/MS Analysis | |||
|---|---|---|---|---|
| Operator | Cutoff(ng/mL) | Test Result | Drug Concentration (ng/mL) | Drug in Urine |
| Site 1 | 1 | Positive | 0.76 | Fentanyl |
| 1 | Negative | 1.04 | Fentanyl | |
| Site 2 | 1 | Positive | 0.76 | Fentanyl |
| 1 | Negative | 1.04 | Fentanyl | |
| Site 3 | 1 | Positive | 0.76 | Fentanyl |
| 1 | Negative | 1.04 | Fentanyl |
Rapid Fentanyl (FYL) Test Dipcard:
| Operator | Co-Innovation Result | Drug free by LC/MS analysis | Less than half the cutoff concentration by LC/MS analysis | Near Cutoff Negative (Between 50% below the cutoff and the cutoff concentration) | Near Cutoff Positive (Between the cutoff and 50% above the cutoff concentration) | High Positive (greater than 50% above the cutoff concentration) | Total |
|---|---|---|---|---|---|---|---|
| Site1 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Site1 | Negative | 27 | 5 | 7 | 1 | 0 | 80 |
| Site2 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Site2 | Negative | 27 | 5 | 7 | 1 | 0 | 80 |
| Site3 | Positive | 0 | 0 | 1 | 8 | 31 | 80 |
| Site3 | Negative | 27 | 5 | 7 | 1 | 0 | 80 |
Analysis of Discordant Results Rapid Fentanyl (FYL) Test Dipcard
| Rapid Fentanyl (FYL) Test Dipcard | LC/MS Analysis | |||
|---|---|---|---|---|
| Operator | Cutoff(ng/mL) | Test Result | DrugConcentration(ng/mL) | Drug in Urine |
| Site 1 | 1 | Positive | 0.76 | Fentanyl |
| 1 | Negative | 1.04 | Fentanyl | |
| Site 2 | 1 | Positive | 0.76 | Fentanyl |
| 1 | Negative | 1.04 | Fentanyl | |
| Site 3 | 1 | Positive | 0.76 | Fentanyl |
{11}------------------------------------------------
| 11Negative | 4 / 41.V | Company of Children Company of ChildrenFentanyi | |||
|---|---|---|---|---|---|
| -- | -- | -- | ---------------- | -------------- | ----------------------------------------------------- |
9. Conclusion:
The data collected in the performance and accuracy studies demonstrate that the Rapid Fentanyl (FYL) Test are substantially equivalent to the predicate device.
--- End of this section ---
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).