(52 days)
Not Found
No
The device description and performance studies describe a standard lateral flow immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. There are no mentions of AI, ML, image processing, or data-driven decision-making beyond the chemical reaction itself.
No.
Explanation: The device is an in vitro diagnostic (IVD) test for detecting Fentanyl in human urine; it does not provide any therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only." for both variations of the test cassette.
No
The device description explicitly states that the device consists of a Test Cassette, a Dropper, and a package insert, which are physical components, not software. The intended use also describes a lateral flow immunochromatographic assay, which is a hardware-based test.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for both the Home Test and the Prescription Use version explicitly states: "For in vitro diagnostic use only."
- Nature of the Test: The device is a "competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine." This describes a test performed in vitro (outside the body) on a biological sample (urine) to diagnose or detect a substance.
- Purpose: The purpose is to detect Fentanyl in human urine, which is a diagnostic activity.
Therefore, based on the provided text, the CLUNGENE Fentanyl Test Cassette is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only.
The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.
This test provides only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS). Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.
Product codes
NGL
Device Description
The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE Fentanyl Test device consists of a Test Cassette, a Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Urine samples prepared at the following concentrations: -100%, +/-75%, +/-50%, +/-25% of the cut-off by spiking fentanyl into drug free-pooled urine specimens. The concentrations of the samples were confirmed by LC/MS. Each sample was aliquoted into individual containers, blind-labeled and randomized.
Summary of Performance Studies
- Analytical Performance - Precision Study: Samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off were used. These samples were prepared by spiking fentanyl in negative samples. Each fentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled. For each concentration, tests were performed two tests per lot per day per operator for 10 days in a randomized order.
- Results:
- Lot 1: -100% cut off (60-/0+), -75% cut off (60-/0+), -50% cut off (60-/0+), -25% cutoff (58-/2+), cut off (33-/27+), +25% cut off (60+/0-), +50% cut off (60+/0-), +75% cut off (60+/0-), +100% cut off (60+/0-).
- Lot 2: -100% cut off (60-/0+), -75% cut off (60-/0+), -50% cut off (60-/0+), -25% cutoff (60-/0+), cut off (26-/34+), +25% cut off (60+/0-), +50% cut off (60+/0-), +75% cut off (60+/0-), +100% cut off (60+/0-).
- Lot 3: -100% cut off (60-/0+), -75% cut off (60-/0+), -50% cut off (60-/0+), -25% cutoff (58-/2+), cut off (32-/28+), +25% cut off (60+/0-), +50% cut off (60+/0-), +75% cut off (60+/0-), +100% cut off (60+/0-).
- Results:
- Analytical Performance - Stability: The devices are stable at 39-86º F for 24 months based on the accelerated stability study.
- Analytical Performance - Interference: Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL or specified concentrations were summarized in tables.
- Analytical Performance - Specificity: Drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of device. The lowest concentration that caused a positive result for each compound was listed. Opioid compounds tested at 100 µg/mL resulted in negative findings, indicating no cross-reactivity.
- Analytical Performance - Effect of Urine Specific Gravity and Urine pH: Urine samples with 1.000 to 1.035 specific gravity or pH 4 to 9 were spiked with target fentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of device.
- Results: All samples at and above +50% Cut-Off were positive, and all samples at and below -50% Cut-Off were negative.
- Comparison Studies: Method comparison studies were performed by three different operators. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results.
- Results (for each of 3 operators):
- Negative LC/MS: 10 Negative (0 Positive)
- Low Negative by LC/MS (less than -50%): 16 Negative (0 Positive)
- Near Cutoff Negative by LC/MS (Between -50% and cutoff): 13 Negative (1 Positive)
- Near Cutoff Positive by LC/MS (Between the cutoff and +50%): 1 Negative (21 Positive for Operator 1, 2 Positive for Operators 2 & 3, 20 Positive for Operators 2 & 3)
- High Positive by LC/MS (greater than +50%): 0 Negative (18 Positive)
- Discordant Results:
- Operator 1: FYL57, LC/MS Result (0.953 ng/mL), Rapid Test Result (Positive)
- Operator 2: FYL66, LC/MS Result (0.987 ng/mL), Rapid Test Result (Positive)
- Operator 3: FYL66, LC/MS Result (0.987 ng/mL), Rapid Test Result (Positive)
- Operator 1: FYL38, LC/MS Result (1.073 ng/mL), Rapid Test Result (Negative)
- Operator 2: FYL19, LC/MS Result (1.083 ng/mL), Rapid Test Result (Negative)
- Operator 2: FYL55, LC/MS Result (1.004 ng/mL), Rapid Test Result (Negative)
- Operator 3: FYL24, LC/MS Result (1.073 ng/mL), Rapid Test Result (Negative)
- Operator 3: FYL55, LC/MS Result (1.004 ng/mL), Rapid Test Result (Negative)
- Results (for each of 3 operators):
- Lay-user study: A lay user study was performed at three testing sites with 140 lay persons.
- Results:
- -100% Cutoff (20 samples, 0 ng/mL by LC/MS): 0 Positive, 20 Negative (100% correct results)
- -75% Cutoff (20 samples, 0.23 ng/mL by LC/MS): 0 Positive, 20 Negative (100% correct results)
- -50% Cutoff (20 samples, 0.53 ng/mL by LC/MS): 0 Positive, 20 Negative (100% correct results)
- -25% Cutoff (20 samples, 0.75 ng/mL by LC/MS): 1 Positive, 19 Negative (95% correct results)
- +25% Cutoff (20 samples, 1.20 ng/mL by LC/MS): 20 Positive, 0 Negative (100% correct results)
- +50% Cutoff (20 samples, 1.46 ng/mL by LC/MS): 20 Positive, 0 Negative (100% correct results)
- +75% Cutoff (20 samples, 1.77 ng/mL by LC/MS): 20 Positive, 0 Negative (100% correct results)
- Additional results: All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis on the package insert revealed a reading grade level of less than 7.
- Results:
- Clinical Studies: Not applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
November 8, 2024
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Hangzhou Clongene Biotech Co.,Ltd. % Jenny Xia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K242802
Trade/Device Name: CLUNGENE Fentanyl Home Test Cassette: CLUNGENE Fentanyl Test Cassette Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: September 14, 2024 Received: September 17, 2024
Dear Jenny Xia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Joseph A. Digitally signed by Joseph A Kotarek -S Kotarek -S Date: 2024.11.08 08:51:37 -05'00' Joseph Kotarek, Ph.D. Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K242802
Device Name
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
Indications for Use (Describe)
The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentany] in human urine at the cut off concentration of 1.0 ng/mL. This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only.
The CLUNGENE Fentanyl Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.
This test provides only a preliminary result. A more specific alternative chemical must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS). Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.
| 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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510(k) SUMMARY K242802
| 1. Date: | September 13, 2024 |
|---|---|
| 2. Submitter: | Hangzhou Clongene Biotech Co., Ltd. |
| No.1 Yichuang Road, Yuhang District | |
| Hangzhou, China | |
| 3. Contact person: | Jenny Xia |
| LSI International Inc. | |
| 504E Diamond Ave., Suite H | |
| Gaithersburg, MD 20877 | |
| Telephone: 301-525-6856 | |
| Email: jxia@lsi-consulting.org | |
| 4. Device Names: | CLUNGENE Fentanyl Home Test Cassette |
| CLUNGENE Fentanyl Test Cassette |
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| NGL | II | 21 CFR § 862.3650 | |
| Opiate Test System | Toxicology (91) |
-
- Predicate Devices:
AllTest Fentanyl Urine Test Cassette (K233417)
- Predicate Devices:
-
- Indications for Use
The CLUNGENE Fentanyl Home Test Cassette is competitive binding, lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.
- Indications for Use
This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) is the preferred confirmatory method. Evaluate preliminary positive results carefully. For in vitro diagnostic use only.
binding, The Fentanyl Test Cassette is competitive CLUNGENE lateral flow immunochromatographic assay for the qualitative detection of Fentanyl in human urine at the cut off concentration of 1.0 ng/mL.
This test provides only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed presumptive positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem massspectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results. For in vitro diagnostic use only.
-
- Device Description
The CLUNGENE Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each CLUNGENE Fentanyl Test device consists of a Test Cassette, a
- Device Description
5
Dropper and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
-
- Substantial Equivalence Information
A summary comparison of features of the CLUNGENE Fentanyl Test and the predicate device is provided in following table.
- Substantial Equivalence Information
| Item | Device | Predicate - K233417 |
|---|---|---|
| Indication(s) | ||
| for Use | For the qualitative determination of | |
| fentanyl in human urine. | Same | |
| Calibrator and Cut-Off | ||
| Values | Fentanyl (FTY) | |
| 1 ng/ml | Same | |
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | ||
| on the principle of antigen antibody | ||
| immunochemistry. | Same | |
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For OTC use | Same |
| Configurations | Cassette | Same |
| Storage | 4-30°C | Same |
Table 1: Features Comparison of CLUNGENE Fentanyl Test and the Predicate Device
-
- Test Principle
The CLUNGENE Fentanyl Tests are immunoassays based on the principle of competitive binding.
- Test Principle
During testing, a 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 fentanyl conjugate and a visible colored line will show up in the test line region. The colored line will not form in the test line region if the fentanyl level exceeds 1 ng/mL because it will saturate all the binding sites of anti-fentanyl antibodies.
To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.
10. Performance Characteristics
-
- Analytical Performance
- Precision a.
Precision studies were carried out for samples with concentrations of -100% cut off, -75% cut off, -50% cut off, -25% cut off, cut off, +25% cut off, +50% cut off, +75% cut off and +100% cut off. These samples were prepared by spiking fentanyl in negative samples. Each fentanyl concentration was confirmed by LC/MS. All sample aliquots were blindly labeled by the person who prepared the samples and didn't take part in the
6
sample testing. For each concentration, tests were performed two tests per lot per day per operator for 10 days in a randomized order.
| Lot Number | -100% cut off | -75% cut off | -50% cut off | -25% cutoff | cut off | +25% cut off | +50% cut off | +75% cut off | +100% cut off |
|---|---|---|---|---|---|---|---|---|---|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 33-/27+ | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 26-/34+ | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 32-/28+ | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
c. Stability
The devices are stable at 39-86º F for 24 months based on the accelerated stability study.
d. Interference
Potential interfering substances found in human urine of physiological or pathological conditions were added to drug-free urine and target drug fentanyl urine with concentrations at 50% below and 50% above Cut-Off levels. These urine samples were tested using three batches of each device. Compounds that showed no interference at a concentration of 100µg/mL or specified concentrations are summarized in the following tables.
| Acetaminophen | Erythromycin | Octopamine |
|---|---|---|
| Acetone (1000 mg/dL) | Ethanol (1%) | O-Hydroxyhippuric acid |
| Acetophenetidin | Fenofibrate | Olanzapine |
| Acetylsalicylic acid | Fenoprofen | Omeprazole |
| Acyclovir | Fluphenazine | Oxalic acid (100 mg/dL) |
| Albumin (100mg/dL) | Furosemide | Oxazepam |
| Albuterol | Galactose (10 mg/dL) | Oxolinic acid |
| Aminopyrine | Gamma globulin (500 mg/dL) | Oxymetazoline |
| Amitriptyline | Gatifloxacin | Papaverine |
| Amobarbital | Gentisic acid | Penicillin G |
| Amoxicillin | Glibenclamide | Perphenazine |
| Ampicillin | Gliclazide | Phencyclidine |
| Apomorphine | Glucose (3000 mg/dL) | Phenelzine |
| Ascorbic acid | Hemoglobin | Phenobarbital |
| Aspartame | Hydralazine | Prednisone |
| Atropine | Hydrochlorothiazide | Procaine |
| Benzilic acid | Hydrocortisone | Promethazine |
| Benzoic acid | Hydroxytyramine | Propoxyphene (50 mg/dL) |
| Benzoylecgonine | Ibuprofen | Propranolol |
| Bilirubin | Imipramine | Propylthiouracil |
| Boric acid (1%) | Isoproterenol | Pseudoephedrine |
| Bupropion | Isoxsuprine | Quinine |
| Caffeine | Ketamine | Ranitidine |
| Captopril | Ketoprofen | Ribavirin |
| Carbamazepine | Labetalol | Riboflavin (10 mg/dL) |
| Chloral hydrate | Levonorgestrel | Rifampicin |
| Chloramphenicol | Lidocaine | Salicylic acid |
| Chlorothiazide | Loperamide | Secobarbital |
| Chlorpheniramine | Maprotiline | Serotonin (5-Hydroxytyramine) |
| Chlorpromazine | MDMA | Simvastatin |
| Cholesterol | Meperidine | Sulfamethazine |
| Clarithromycin | Meprobamate | Sulindac |
| Clomipramine | Methamphetamine | Tetrahydrocortisone 3-(β- Dglucuronide) |
7
| Clonidine | Methapyrilene | Tetrahydrocortisone 3-acetate |
|---|---|---|
| Cortisone | Methaqualone | Tetrahydrozoline |
| Cotinine | Methoxyphenamine | Theophylline |
| Creatinine | Metoprolol tartrate | Thiamine |
| Cyclobenzaprine | Metronidazole (300 µg/mL) | Thioridazine |
| Deoxycorticosterone | Mifepristone | Triamterene |
| Desipramine | Montelukast sodium | Trifluoperazine |
| Dextromethorphan | N-Acetylprocainamide | Trimethoprim |
| Diazepam | NaCl (4000 mg/dL) | Tyramine |
| Diclofenac | Nalidixic acid | Urea (2000 mg/dL) |
| Diflunisal | Naloxone | Uric acid |
| Digoxin | Naltrexone | Valproic acid (250 µg/mL) |
| Diphenhydramine | Naproxen | Venlafaxine |
| DL-Tryptophan | Niacinamide | Verapamil |
| DL-Tyrosine | Nicotine | Zomepirac |
| Doxepin | Nifedipine | β-Estradiol |
| Ecgonine methyl ester | Norethindrone | Δ9-THC |
| Ephedrine | Nortriptyline | / |
| Epinephrine hydrochloride | Noscapine |
e. Specificity
To test specificity, drug metabolites and other components that are likely to interfere in urine samples were tested using three batches of device. The lowest concentration that caused a positive result for each compound are listed below.
| Fentanyl (Cutoff=1ng/mL) | Minimum concentration required to obtain a positive result (ng/mL) | % Cross-Reactivity |
|---|---|---|
| Acetyl fentanyl | 1 | 100% |
| Acrylfentanyl | 1 | 100% |
| Isobutyryl fentanyl | 2.5 | 40% |
| Ocfentanil | 5 | 20% |
| Butyryl fentanyl | 5 | 20% |
| Furanyl fentanyl | 10 | 10% |
| Valeryl fentanyl | 5 | 20% |
| (±) β-hydroxythiofentanyl | 2.5 | 40% |
| 4-Fluoro-isobutyrylfentanyl | 10 | 10% |
| Para-fluorobutyryl fentanyl | 5 | 20% |
| Para-fluoro fentanyl | 2.5 | 40% |
| Carfentanil | 50 | 2% |
| Sufentanil | 25 | 4% |
| Alfentanil | 7500 | 0.01% |
| ω-1-Hydroxy fentanyl | 2500 | 0.04% |
| (±)-3-cis-methyl fentanyl | 75 | 1.33% |
| Despropionyl fentanyl (4-ANPP) | 2000 | 0.05% |
| β-hydroxyfentanyl | 100 | 1% |
| Thiofentanyl | 50 | 2% |
| Cyclopropyl Fentanyl | 10 | 10% |
| Trazodone | 1000 | 0.1% |
| Remifentanil | > 100000 | 100000 |
| % of Cutoff | Number
of
samples | Fentanyl Concentration
by LC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|------------------------------------------------|
| | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 0.23 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.53 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.75 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1.20 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.46 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.77 | 20 | 0 | 100 |
Lay-users were also given surveys on the ease of understanding the package insert instructions. All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis was performed on the package insert and the score revealed a reading grade level of less than 7.
-
- Clinical Studies
Not applicable.
- Clinical Studies
-
- Conclusion
Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, method comparison and Lay-user studies of the devices, it's concluded that the CLUNGENE Fentanyl Test is substantially equivalent to the predicate.
- Conclusion