(54 days)
Not Found
No
The device description and performance studies indicate a standard immunoassay for qualitative detection, with no mention of AI or ML components. The analysis of results is based on visual interpretation of the test panel, not algorithmic processing.
No
This device is an immunoassay intended for the qualitative detection of Fentanyl and Norfentanyl in human urine. It is a diagnostic device, not a therapeutic one, as it identifies substances in the body rather than treating a condition.
Yes
The device is described as an immunoassay intended for the "qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine", which is a diagnostic purpose to identify the presence of specific substances in a biological sample.
No
The device description clearly states it consists of a "Test Panel" and a "package insert," and that the Test Panel is sealed in an "aluminum pouch." This indicates a physical, hardware-based immunoassay test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to provide information about a person's health status (presence of specific drugs).
- Device Description: The description confirms it's an "immunoassay intended for the qualitative detection of fentanyl and norfentanyl in human urine." Immunoassays are a common type of IVD.
- Anatomical Site: The sample is "human urine," which is a biological specimen analyzed in vitro.
- Performance Studies: The document describes performance studies involving the analysis of clinical samples and comparison to a reference method (LC/MS), which are standard practices for evaluating IVDs.
- Predicate Device: The mention of a "Predicate Device" with a K number (K241969) indicates that this device is being compared to a previously cleared medical device, which is a requirement for certain types of IVD submissions to regulatory bodies like the FDA.
- Intended User / Care Setting: While it's intended for Over-The-Counter Use, this is a classification of how the IVD is used, not whether it is an IVD.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine. The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method.
The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine. The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
NGL
Device Description
The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) and ETERBIO Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel 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
For OTC use
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
1. Analytical Performance
- a. Precision: 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 for each target drug. These samples were prepared by spiking fentanyl or norfentanyl in negative urine samples. Each fentanyl or norfentanyl 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 sample testing. For each concentration, tests were performed six tests per day per device lot for 10 days in a randomized order.
- c. Stability: The devices are stable at 36-86F for 24 months based on the real 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.
- 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.
- f. Effect of Urine Specific Gravity and Urine pH: To investigate the effect of urine specific gravity and urine pH, urine samples, with 1.000 to 1.035 specific gravity or urine samples with pH 4 to 9 were spiked with targets fentanyl and norfentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of device. Results were all positive for samples at and above +50% Cut-Offs and all negative for samples at and below -50% Cut-Offs.
2. Comparison Studies
Method comparison studies for the ETERBIO Fentanyl Test 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.
3. Lay-user study
A lay user study was performed at three testing sites with 140 lay persons. They had diverse educational and professional backgrounds and ranged in age from 18 to >50 years. Urine samples were prepared at the following concentrations; -100%, +/-50%, +/-50%, +/-25% of the cut-offs by spiking drug(s) 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. Each participant was provided with the package insert, 1 blind labeled sample and a device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 20, 2024
Image /page/0/Picture/1 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.
Eterbio, Inc. % Jenny Xia Director LSI International Inc 504 E Diamond Ave Suite H Gaithersburg, Maryland 20877
Re: K243064
Trade/Device Name: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: September 26, 2024 Received: September 27, 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,
Image /page/2/Picture/3 description: The image shows a digital signature. The signature is for Joseph A. Kotarek -S. The date of the signature is 2024.11.20, and the time is 09:04:19 -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) K243064
Device Name
ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) ETERBIO Fentanyl/Norfentanyl Home Test
Indications for Use (Describe)
The ETERBIO Fentany]Norfentary] Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical is required. GC/MS or LC/MS is the preferred confirmatory method.
The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
| 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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4
510(k) SUMMARY
K243064
-
- Date: October 21, 2024 2. Submitter: Eterbio, Inc. 420, No. 1316, Caixia Street, Zhuhai, Guangdong China 3. Contact person: Jenny Xia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: jxia@lsi-consulting.org 4. Device Names: ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) ETERBIO Fentanyl/Norfentanyl Home Test
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| NGL | II | 21 CFR § 862.3650 | |
| Opiate Test System | Toxicology (91) |
-
- Predicate Devices:
Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel (K241969)
- Predicate Devices:
-
- Indications for Use
The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
- Indications for Use
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. It provides a preliminary screening result only. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
The ETERBIO Fentanyl Norfentanyl Home Test is an immunoassay intended for the qualitative detection of Fentanyl (FTY) /Norfentanyl (NFTY) in human urine:
| Drug (Identifier) | Calibrator | Cut-off Level |
|---|---|---|
| Fentanyl (FYL) | Fentanyl | 1ng/mL |
| Norfentanyl (NFYL) | Norfentanyl | 5ng/mL |
The test is available as a single panel for FYL or NFYL, or as a dual panel combining both FYL and NFYL. This test provides only preliminary results. For a confirmed analytical outcome, a more specific chemical method is required. GC/MS or LC/MS is the preferred confirmatory method.
5
-
- Device Description
Rapid Test ETERBIO Fentanyl/Norfentanyl Gold) and ETERBIO The Fentanyl/Norfentanyl Home Test are immunoassays intended for the qualitative detection of fentanyl and norfentanyl in human urine. Each ETERBIO fentanyl/norfentanyl urine test device consists of a Test Panel and a package insert. Each Test Panel is sealed with sachets of desiccant in an aluminum pouch.
- Device Description
- Substantial Equivalence Information A summary comparison of features of the ETERBIO Fentanyl Test and the predicate devices is provided in following table.
| Table 1: Features Comparison of ETERBIO Fentany] Test and the Predicate Device | |||
|---|---|---|---|
| Item | Device | Predicate – K241969 | |
| Indication(s) | |||
| for Use | For the qualitative determination of | ||
| fentanyl in human urine. | Same | ||
| Calibrator and Cut-Off | |||
| Values | Fentanyl (FTY) | ||
| 1 ng/ml | |||
| Norfentanyl (NFTY) | |||
| 5 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 | Panel | Same | |
| Storage | 2-30°C | Same |
-
- Test Principle
ETERBIO The ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) and Fentanyl/Norfentanyl Home Test are immunoassays based on the principle of competitive binding.
- Test Principle
During testing, a urine specimen migrates upward by capillary action. Each target drug, if present in the urine specimen below its cutoff, will not saturate the binding sites of antibodycoated particles in the test device. The antibody-coated particles will then be captured by immobilized drug 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 drug level exceeds the cutoff because it will saturate all the binding sites of anti-drug 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.
-
- Performance Characteristics
6
1. Analytical Performance
a. Precision
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 for each target drug. These samples were prepared by spiking fentanyl or norfentanyl in negative urine samples. Each fentanyl or norfentanyl 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 sample testing. For each concentration, tests were performed six tests per day per device lot for 10 days in a randomized order.
Fentanyl
| Lot
Number | -100%
cut off | -75%
cut off | -50%
cut off | -25%
cutoff | +25%
cut off | +50%
cut off | +75%
cut off | +100%
cut off |
|---------------|------------------|-----------------|-----------------|----------------|-----------------|-----------------|-----------------|------------------|
| Lot 1 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 27+/33- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 60-/0+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- |
Norfentanyl
| 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+ | 27+/33- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 59-/1+ | 26+/34- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
c. Stability
The devices are stable at 36-86F for 24 months based on the real 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 | Creatinine | Ketamine | Perphenazine |
|---|---|---|---|
| Acetone (1000mg/dL) | Cyclobenzaprine | Ketoprofen | Phencyclidine |
| Acetophenetidin | Deoxycorticosterone | Labetalol | Phenelzine |
| Acetylsalicylic acid | Desipramine | Lidocaine | Phenobarbital |
| Albumin (100mg/dL) | Dextromethorphan | Loperamide | Prednisone |
| Albuterol | Diclofenac | Maprotiline | Propoxyphene |
| Aminopyrine | Diflunisal | Meperidine | Propranolol |
| Amitriptyline | Digoxin | Meprobamate | Pseudoephedrine |
| Amobarbital | Diphenhydramine | Methapyrilene | Quinine |
| Amoxicillin | DL-Tryptophan | Methaqualone | Ranitidine |
| Ampicillin | DL-Tyrosine | Methoxyphenamine | Riboflavin (10mg/dL) |
| Apomorphine | Doxepin | Metronidazole | Salicylic acid |
| Ascorbic acid | Ecgonine methyl ester | N-Acetylprocainamide | Secobarbital |
| Aspartame | Ephedrine | NaCl (4000mg/dL) | Serotonin(5-Hydroxytyramine) |
| Atropine | Erythromycin | Nalidixic acid | Sulfamethazine |
| Benzilic acid | Ethanol (1%) | Naloxone | Sulindac |
| Benzoic acid | Fenoprofen | Naltrexone | Tetrahydrocortisone 3-(β- |
| Dglucuronide) | |||
| Benzoylecgonine | Fluphenazine | Naproxen | Tetrahydrocortisone 3-acetate |
| Bilirubin | Furosemide | Niacinamide | Tetrahydrozoline |
| Boric Acid (1%) | Galactose (10mg/dL) | Nicotine | Thiamine |
7
| Bupropion | Gamma Globulin (500mg/dL) | Nifedipine | Thioridazine |
|---|---|---|---|
| Caffeine | Gentisic acid | Norethindrone | Triamterene |
| Carbamazepine | Glucose (3000mg/dL) | Nortriptyline | Trifluoperazine |
| Chloral hydrate | Hemoglobin | Noscapine | Trimethoprim |
| Chloramphenicol | Hydralazine | O-Hydroxyhippuric acid | Tyramine |
| Chlorothiazide | Hydrochlorothiazide | Octopamine | Urea (2000mg/dL) |
| Chlorpromazine | Hydrocortisone | Oxalic acid (100mg/dL) | Uric acid |
| Cholesterol | Hydroxytyramine | Oxazepam | Valproic acid (250µg/mL) |
| Clomipramine | Ibuprofen | Oxolinic acid | Venlafaxine |
| Clonidine | Imipramine | Oxymetazoline | Verapamil |
| Cortisone | Isoproterenol | Papaverine | Zomepirac |
| Cotinine | Isoxsuprine (10µg/mL) | Penicillin G | β-Estradiol |
| α-Estradiol | Estrone | 7-Aminonitrazepam | Fenfluramine |
| Fenofibrate | Amlodipine besylate | Phentermine | Phenylethylamine |
| Fotemustine | Promazine | Promethazine | Gemfibrozil |
| Aspirin | Gentisic acid | Pyridoxine | Baclofen |
| Guaiacolglyceryl ether | Pyrilamine | Pyrogallol | Benzocaine |
| Hexobarbital | Quinidine | Quinolinic Acid | Benzylpiperiazine |
| Hydroxybutyric Acid | Bromo-2,5,Dimethoxyphenethylamine | Sodium Azide | Carisoprodol |
| Cetirizine | Lamotrigine | Tetracycline | Lisinopril |
| Chlordiazepoxide | Loratidine | Chlorpheniramine | Trifluoromethylphenyl-piperazine |
| Clofibrate | Tryptamine | Metoprolol | Creatine Hydrate |
| N-desmethyl Tapentadol | γ-Cyclodextrin | Zolpidem | Cyproheptadine |
| Demoxepam | 7-Aminoflunitrazepam | Metformin | Norpseudoephedrine |
| Nicotinic Acid | Oxazepam Glucuronide | Lorazepam Glucuronide | LSD |
| Dimethyl-aminoantipyrine | THC | L-thyroxine | Diphenylhydantoin |
| Methylphenidate | Norpropoxyphene |
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 |
|--------------------------------|--------------------------------------------------------------------------------|------------------------|
| (±) β-hydroxythiofentanyl | 2.8 | 35.7% |
| (±)-3-cis-methyl fentanyl | 5 | 20% |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.3% |
| 9-Hydroxy Risperidone | 10000 | 0.01% |
| Acetyl fentanyl | 1.2 | 83.3% |
| Acetyl norfentanyl | 10000 | 0.01% |
| Acrylfentanyl | 1.2 | 83.3% |
| Alfentanil | 100000 | 0.001% |
| Butyryl fentanyl | 1.6 | 62.5% |
| Carfentanil | 500 | 0.20% |
| Despropionyl fentanyl (4-ANPP) | 50000 | 0.002% |
| Fentanyl | 1 | 100% |
| Furanyl fentanyl | 1.75 | 57.1% |
| Isobutyryl fentanyl | 1.5 | 66.7% |
| Labetalol Hydrochloride | 100000 | 0.001% |
| MT-45 | 10000 | 0.01% |
| Norcarfentanil | 10000 | 0.01% |
8
| Norfentanyl | 5000 | 0.02% |
|---|---|---|
| Ocfentanil | 1.5 | 66.7% |
| Para-fluoro fentanyl | 3 | 33.3% |
| Para-fluorobutyryl fentanyl | 3 | 33.3% |
| Remifentanil | 10000 | 0.01% |
| Risperidone | 1000 | 0.1% |
| Sufentanil | 625 | 0.16% |
| Thienyl Fentnayl | 1000 | 0.1% |
| Trans-d, I 3-Methylfentanyl | 1000 | 0.1% |
| Trazodone | 1000 | 0.1% |
| U-47700 | 100000 | 0.001% |
| Valeryl fentanyl | 2.5 | 40 % |
| ω- 1-Hydroxyfentanyl | 20000 | 0.005% |
| Norfentanyl (Cutoff=5ng/mL) | Minimum
concentration
required to obtain a
positive result
(ng/mL) | % Cross-
Reactivity |
|--------------------------------|--------------------------------------------------------------------------------|------------------------|
| (+) β-hydroxythiofentanyl | 7 | 71.4% |
| (+)-3-cis-methyl fentanyl | 10 | 50% |
| 4-Fluoro-isobutyrylfentanyl | 25 | 20% |
| 9-Hydroxy Risperidone | 10000 | 0.05% |
| Acetyl fentanyl | 10 | 50% |
| Acetyl norfentanyl | 200 | 2.5% |
| Acry lfentanyl | 10 | 50% |
| Alfentanil | >100000/mL | 100000/mL | 100000/mL | 100000/mL | 100000/mL | 100000/mL | 50 years. Urine samples were prepared at the following concentrations; -100%, +/-50%, +/-50%, +/-25% of the cut-offs by spiking drug(s) 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. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:
| % of Cutoff | Number | Fentanyl Concentration | Lay person results | The |
|---|---|---|---|---|
| ------------- | -------- | ------------------------ | -------------------- | ----- |
11
| | of
samples | by LC/MS
(ng/mL) | No. of
Positive | No. of
Negative | percentage of
correct results
(%) |
|--------------|---------------|---------------------|--------------------|--------------------|-----------------------------------------|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100.0% |
| -75% Cutoff | 20 | 0.25 | 0 | 20 | 100.0% |
| -50% Cutoff | 20 | 0.52 | 0 | 20 | 100.0% |
| -25% Cutoff | 20 | 0.75 | 1 | 19 | 95.0% |
| +25% Cutoff | 20 | 1.30 | 20 | 0 | 100.0% |
| +50% Cutoff | 20 | 1.55 | 20 | 0 | 100.0% |
| +75% Cutoff | 20 | 1.65 | 20 | 0 | 100.0% |
| % of Cutoff | Number of samples | Norfentanyl Concentration by LC/MS (ng/mL) | Lay person results | The percentage of correct results (%) | |
|---|---|---|---|---|---|
| -100% Cutoff | 20 | 0 | 0 | 20 | 100.0% |
| -75% Cutoff | 20 | 1.27 | 0 | 20 | 100.0% |
| -50% Cutoff | 20 | 2.54 | 0 | 20 | 100.0% |
| -25% Cutoff | 20 | 3.78 | 0 | 20 | 100.0% |
| +25% Cutoff | 20 | 6.55 | 20 | 0 | 100.0% |
| +50% Cutoff | 20 | 7.85 | 20 | 0 | 100.0% |
| +75% Cutoff | 20 | 8.95 | 20 | 0 | 100.0% |
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 a substantial equivalence decision.
- Conclusion