(29 days)
Not Found
No
The device is a lateral flow immunoassay, which is a chemical test that provides a visual result. There is no mention of any computational analysis or algorithms being used to interpret the results.
No
This device is for in vitro diagnostic use, specifically for qualitative detection of 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." multiple times.
No
The device description explicitly states it consists of a "Test Device in format of Cassette or Dip Card" 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 section for all listed variations of the SAFElife™ Fentanyl Urine Test explicitly states: "For in vitro diagnostic use."
- Nature of the Test: The device is designed to detect a substance (Fentanyl) in a biological sample (human urine) outside of the body, which is the definition of an in vitro diagnostic test.
- Intended Use: The purpose is to provide a preliminary test result for the presence of Fentanyl, which is a diagnostic step, even though confirmation by a more specific method is required.
N/A
Intended Use / Indications for Use
The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
lt is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
NGL
Device Description
The Wondfo SAFElife™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Wondfo SAFElife™ Fentanyl Test consists of a Test Device in format of Cassette or Dip Card, and a package insert. Each Test Device 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For Over The Counter (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)
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 sample testing. For each concentration, tests were performed two tests per day for 25 days per device lot in a randomized order.
Method comparison studies for the Wondfo SAFElife™ Fentanyl Test were performed using three different lots of the device. Operators ran 84 (41 negative and 43 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results.
A lay user study was performed at three intended user sites with 140 lay persons for each device format. 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%, +/-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. Each participant was provided with the package insert, 1 blind labeled sample and a device.
Key results from lay-user study (Cassette and Dip Card):
-100% Cutoff (0 ng/mL): 100% correct results (0 positive, 20 negative)
-75% Cutoff (0.2 ng/mL): 100% correct results (0 positive, 20 negative)
-50% Cutoff (0.5 ng/mL): 100% correct results (0 positive, 20 negative)
-25% Cutoff (0.7 ng/mL): 95% correct results (1 positive, 19 negative)
+25% Cutoff (1.2 ng/mL): 100% correct results (20 positive, 0 negative)
+50% Cutoff (1.4 ng/mL): 100% correct results (20 positive, 0 negative)
+75% Cutoff (1.7 ng/mL): 100% correct results (20 positive, 0 negative)
Lay-users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis of the package insert 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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Guangzhou Wondfo Biotech Co., Ltd. % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K241741
Trade/Device Name: SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentany) (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: June 13, 2024 Received: June 17, 2024
Dear Joe Shia:
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.
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
1
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, Digitally signed by
Joseph A. Kotarek Joseph A. Kotarek -S Date: 2024.07.16
11:44:38 -04'00' 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241741 Device Name
SAFElife™ Fentanyl Urine Home Test (Cassette); SAFElife™ Fentanyl (FTY) Urine Test Cassette; SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card); SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel
Indications for Use (Describe)
The SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatoqraphic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
lt is not intended to distinquish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/ MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
3
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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4
510(k) SUMMARY K241741
| 1. Date: | July 8, 2024 |
|---|---|
| 2. Submitter: | Guangzhou Wondfo Biotech Co., Ltd. |
| No.8 Lizhishan Road, Science City, Huangpu District | |
| Guangzhou, China | |
| 3. Contact person: | Joe Shia |
| LSI International Inc. | |
| 504E Diamond Ave., Suite H | |
| Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Email: shiajl@yahoo.com | |
| 4. Device Names: | SAFElife™ Fentanyl Urine Home Test (Cassette) |
| SAFElife™ Fentanyl (FTY) Urine Test Cassette | |
| SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) | |
| SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel |
| 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 SAFElife™ Fentanyl Urine Home Test (Cassette) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentany] in human urine at cutoff concentration of 1 ng/mL.
- Indications for Use
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ Fentanyl (FTY) Urine Test Cassette is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
5
The SAFElife™ T-Dip Fentanyl Urine Home Test (Dip Card) is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentany] in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use. For Over The Counter (OTC) use.
The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
The SAFElife™ T-Dip Fentanyl (FTY) Urine Test Panel is a competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl (FTY) in human urine at cutoff concentration of 1 ng/mL.
For in vitro diagnostic use.
It is not intended to distinguish between prescription drug or abuse of the drug. Clinical consideration and professional judgment should be applied to the drug of abuse test result, particularly in evaluating a preliminary positive result. The test provides only preliminary test results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the recommended confirmatory method.
-
- Device Description
The Wondfo SAFElife™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each Wondfo SAFElife™ Fentanyl Test consists of a Test Device in format of Cassette or Dip Card, and a package insert. Each Test Device is sealed with sachets of desiccant in an aluminum pouch.
- Device Description
-
- Substantial Equivalence Information
A summary comparison of features of the Wondfo SAFElife™ Fentanyl Test and the predicate devices 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, Dip Card | Cassette |
| Storage | 4-30°C | Same |
Table 1: Features Comparison of Wondfo SAFElife™ Fentanyl Test and the Predicate Device
6
9. Test Principle
The Wondfo SAFElife™ Fentanyl Tests are immunoassays based on the principle of competitive binding.
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
- 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. 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 sample testing. For each concentration, tests were performed two tests per day for 25 days per device lot in a randomized order.
Cassette
| 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 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 46-/4+ | 27+/23- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 25+/25- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
Dip Card
| 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 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 24+/26- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 2 | 50-/0+ | 50-/0+ | 50-/0+ | 47-/3+ | 28+/22- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
| Lot 3 | 50-/0+ | 50-/0+ | 50-/0+ | 48-/2+ | 23+/27- | 50+/0- | 50+/0- | 50+/0- | 50+/0- |
c. Stability
The devices are stable at 36-86F 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 | Doxepin | Nortriptyline |
|---|---|---|
| Acetone (1000 mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Erythromycin | Octopamine |
| Albumin (100 mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline | Furosemide | Oxymetazoline |
| Amobarbital | Galactose (10 mg/dL) | Papaverine |
| Amoxicillin | Gamma globulin (500 mg/dL) | Penicillin G |
| Ampicillin | Gentisic acid | Perphenazine |
| Apomorphine | Glucose (3000 mg/dL) | Phencyclidine |
| Ascorbic Acid | Hemoglobin | Phenelzine |
| Aspartame | Hydralazine | Phenobarbital |
| Atropine | Hydrochlorothiazide | Prednisone |
| Benzilic acid | Hydrocortisone | Propoxyphene (50 µg/mL) |
| Benzoic acid | Hydroxytyramine | Propranolol |
| Benzoylecgonine | Ibuprofen | Pseudoephedrine |
| Bilirubin | Imipramine | Quinine |
| Boric acid (1% w/v) | Isoproterenol | Ranitidine |
| Bupropion | Isoxsuprine | Riboflavin (10 mg/dL) |
| Caffeine | Ketamine | Salicylic acid |
| Carbamazepine | Ketoprofen | Secobarbital |
| Chloral hydrate | Labetalol | Serotonin (5-hydroxytyramine) |
| Chloramphenicol | Lidocaine | Sulfamethazine |
| Chlorothiazide | Loperamide | Sulindac |
| Chlorpromazine | Maprotiline | Tetrahydrocortisone 3-(β- |
| Dglucuronide) | ||
| Cholesterol | Meperidine (50 µg/mL) | Tetrahydrocortisone 3-acetate |
| Clomipramine | Meprobamate | Tetrahydrozoline |
| Clonidine | Methapyrilene | Thiamine |
| Cortisone | Methaqualone | Thioridazine |
| Cotinine | Methoxyphenamine | Triamterene |
| Creatinine | Metronidazole (300 µg/mL) | Trifluoperazine |
| Cyclobenzaprine | N-Acetylprocainamide | Trimethoprim |
| Deoxycorticosterone | NaCl (4000 mg/dL) | Tyramine |
| Desipramine | Nalidixic acid | Urea (2000 mg/dL) |
| Dextromethorphan | Naloxone | Uric acid |
| Diclofenac | Naltrexone | Valproic acid (250 µg/mL) |
| Diflunisal | Naproxen | Venlafaxine |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine | Zomepirac |
| DL-Tryptophan | Nifedipine | β-Estradiol |
| DL-Tyrosine | Norethindrone |
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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. There are no differences in the test results for different device format.
8
| Fentanyl (Cutoff=1ng/mL) | Minimum
concentration required
to obtain a positive
result (ng/mL) | % Cross-Reactivity |
|--------------------------------|-----------------------------------------------------------------------------|--------------------|
| Acetyl fentanyl | 16 | 6.25% |
| Acrylfentanyl | 1 | 100.00% |
| ω-1-Hydroxyfentanyl | 20,000 | 0.005% |
| Isobutyryl fentanyl | 1 | 100.00% |
| Ocfentanil | 2.3 | 43.48% |
| Butyryl fentanyl | 2 | 50.00% |
| Furanyl fentanyl | 1 | 100.00% |
| Valeryl fentanyl | 2.5 | 40.00% |
| (±) β-hydroxythiofentanyl | 2.5 | 40.00% |
| 4-Fluoro-isobutyrylfentanyl | 3 | 33.33% |
| Para-fluorobutyryl fentanyl | 4 | 25.00% |
| Para-fluoro fentanyl | 2.5 | 40.00% |
| (+)-3-cis-methyl fentanyl | 50 | 2.00% |
| Carfentanil | 2 | 50.00% |
| Sufentanil | 15 | 6.67% |
| Alfentanil | 7500 | 0.01% |
| Despropionyl fentanyl (4-ANPP) | 2,000 | 0.05% |
| Remifentanil | >100 µg/mL | 100 µg/mL | 100 µg/mL | 100 µg/mL | 50 years. Urine samples were 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. Each participant was provided with the package insert, 1 blind labeled sample and a device. The results are summarized below:
| | Number
of
samples | Fentanyl Concentration
by LC/MS
(ng/mL) | Lay person results | | The
percentage of
correct results
(%) |
|--------------|-------------------------|-----------------------------------------------|--------------------|--------------------|------------------------------------------------|
| % of Cutoff | | | No. of
Positive | No. of
Negative | |
| -100% Cutoff | 20 | 0 | 0 | 20 | 100 |
| -75% Cutoff | 20 | 0.2 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.5 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.7 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1.2 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.4 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.7 | 20 | 0 | 100 |
Cassette
Dip Card
| % 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 | 0.2 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.5 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.7 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1.2 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.4 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.7 | 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
11
reading analysis was performed on the package insert and the score revealed a reading grade level of less than 7.
4. Clinical Studies
Not applicable.
11. 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.