(30 days)
Not Found
No
The device is described as a rapid visual immunoassay, which relies on chemical reactions and visual interpretation, not AI/ML algorithms. There is no mention of AI, ML, or related terms in the summary.
No.
This device is an in vitro diagnostic device used for the qualitative, presumptive detection of Fentanyl in human urine specimens, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states, "It is for in vitro diagnostic use only," which directly indicates its function as a diagnostic device.
No
The device description explicitly states that the device consists of a Test Cassette and a Dropper, which are physical hardware components. The performance studies also describe testing these physical devices with urine samples.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "It is for in vitro diagnostic use only."
- Nature of the Test: The device performs a "rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens." This is a laboratory test performed on a biological sample (urine) outside of the body, which is the definition of an in vitro diagnostic test.
- Purpose: The purpose is to detect a substance (Fentanyl) in a biological sample for diagnostic or screening purposes (in this case, presumptive detection of Fentanyl use).
The other information provided, such as the device description, performance studies, and intended user (Over-The-Counter Use), further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
The FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Product codes
NGL
Device Description
The FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ 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 specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter 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)
Analytical Performance
- 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 10 days per device lot in a randomized order. Results for Lot 1: 60-/0+ for -100%, -75%, -50% cut off; 58-/2+ for -25% cut off; 35+/25- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off. Results for Lot 2: 60-/0+ for -100%, -75%, -50% cut off; 58-/2+ for -25% cut off; 36+/24- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off. Results for Lot 3: 60-/0+ for -100%, -75%, -50% cut off; 57-/3+ for -25% cut off; 35+/25- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off.
- Stability: The devices are stable at 36-86F for 24 months based on the real-time stability study.
- 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 (list of compounds provided).
- 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 was listed (table provided). Opioid compounds tested at 100ug/mL showed negative results, indicating no cross-reactivity.
- 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 were all positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.
Comparison Studies
- Method Comparison: Performed using three different lots of the device. Operators ran 82 (42 negative and 40 positive) unaltered clinical samples. Samples were blind labeled and compared to LC/MS results.
- Operator 1: 0 positive for Negative, Low Negative; 2 positive for Near Cutoff Negative; 16 positive for Near Cutoff Positive; 22 positive for High Positive. 5 negative for Negative; 16 negative for Low Negative; 19 negative for Near Cutoff Negative; 2 negative for Near Cutoff Positive; 0 negative for High Positive.
- Operator 2: 0 positive for Negative, Low Negative; 2 positive for Near Cutoff Negative; 16 positive for Near Cutoff Positive; 22 positive for High Positive. 5 negative for Negative; 16 negative for Low Negative; 19 negative for Near Cutoff Negative; 2 negative for Near Cutoff Positive; 0 negative for High Positive.
- Operator 3: 0 positive for Negative, Low Negative; 3 positive for Near Cutoff Negative; 17 positive for Near Cutoff Positive; 22 positive for High Positive. 5 negative for Negative; 16 negative for Low Negative; 18 negative for Near Cutoff Negative; 1 negative for Near Cutoff Positive; 0 negative for High Positive.
- Discordant Results:
- Operator 1: Sample F0031 (0.89 ng/mL) -> +, Sample F0094 (0.94 ng/mL) -> +, Sample F0001 (1 ng/mL) -> -, Sample F0084 (1.1 ng/mL) -> -.
- Operator 2: Sample F0048 (0.93 ng/mL) -> +, Sample F0094 (0.94 ng/mL) -> +, Sample F0001 (1 ng/mL) -> -, Sample F0084 (1.1 ng/mL) -> -.
- Operator 3: Sample F0031 (0.89 ng/mL) -> +, Sample F0048 (0.93 ng/mL) -> +, Sample F0094 (0.94 ng/mL) -> +, Sample F0001 (1 ng/mL) -> -.
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 20 to >50 years. Urine samples were prepared at specified concentrations relative to the cut-off (-100%, +/-75%, +/-50%, +/-25%). Concentrations 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.
- Results:
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct).
- -75% Cutoff (0.28 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct).
- -50% Cutoff (0.51 ng/mL, 20 samples): 0 Positive, 20 Negative (100% correct).
- -25% Cutoff (0.73 ng/mL, 20 samples): 1 Positive, 19 Negative (95% correct).
- +25% Cutoff (1.23 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct).
- +50% Cutoff (1.48 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct).
- +75% Cutoff (1.75 ng/mL, 20 samples): 20 Positive, 0 Negative (100% correct).
- All lay users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis revealed a reading grade level of less than 7 for the package insert.
Clinical Studies
- Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (specific metrics like sensitivity, specificity, PPV, NPV are not explicitly presented, but raw counts from comparison studies are available.)
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
Image /page/0/Picture/0 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 USA seal. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".
Assure Tech LLC % Joe Shia Director LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K240351
Trade/Device Name: FaStep™ Fentanyl Rapid Test Device (Urine); FaStep™ Rapid Fentanyl Urine Test (Urine) Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL Dated: February 2, 2024 Received: February 5, 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the 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.
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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Joseph A. Digitally signed by Kotarek -S Date: 2024.03.06
19-05'00'
Joseph Kotarek Branch Chief for Toxicology Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K240351
Device Name
FaStep™ Fentanyl Rapid Test Device (Urine) FaStep™ Rapid Fentanyl Urine Test (Urine)
Indications for Use (Describe)
The FaStep 111 Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL.
It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
| 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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3
510(k) SUMMARY K240351
-
- Date: March 5, 2024 2. Submitter: Assure Tech. LLC. 1521 Concord Pike, Suite 201 Wilmington, DE 19803 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
- FaStepTM Fentanyl Rapid Test Device (Urine) 4. Device Names: FaStepTM Rapid Fentanyl Urine Test (Urine)
| 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 FaStep™ Fentanyl Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentany] in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
- Indications for Use
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
The FaStep™ Rapid Fentanyl Urine Test (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of Fentanyl in human urine specimens at a cut-off concentration of 1.0 ng/mL. It is for in vitro diagnostic use only.
The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
-
- Device Description
The FaStep™ Fentanyl Tests are immunoassays intended for the qualitative detection of fentanyl in human urine. Each FaStep™ 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.
- Device Description
-
- Substantial Equivalence Information
4
A summary comparison of features of the FaStep™ Fentanyl Test and the predicate devices is provided in following table.
| 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 FaStep™ Fentanyl Test and the Predicate Device
-
- Test Principle
The FaStepTM 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.
- Test Principle
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 10 days per device lot in a randomized order.
5
| 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+ | 35+/25- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 58-/2+ | 36+/24- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 57-/3+ | 35+/25- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
c. Stability
The devices are stable at 36-86F for 24 months based on the real-time 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 |
| 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 | Tetrahydrocortisone 3-acetate |
| Clomipramine | Meprobamate | Tetrahydrozoline |
| Clonidine | Methapyrilene | Thiamine |
| Cortisone | Methaqualone | Thioridazine |
| Cotinine | Methoxyphenamine | Triamterene |
| Creatinine | Metronidazole (300 µg/mL) | Trifluoperazine |
6
| 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 ug/mL) |
| Diflunisal | Naproxen | Venlafaxine |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine | Zomepirac |
| DL-Tryptophan | Nifedipine | B-Estradiol |
| DL-Tyrosine | Norethindrone |
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 | 5 | 20.00 |
| Acrylfentanyl | 5 | 20.00 |
| ω-1-Hydroxyfentanyl | 50000 | 0.002 |
| Isobutyryl fentanyl | 5 | 20.00 |
| Ocfentanil | 100 | 1.00 |
| Butyryl fentanyl | 25 | 4.00 |
| Furanyl fentanyl | 10 | 10.00 |
| Valeryl fentanyl | 50 | 2.00 |
| (±) β-hydroxythiofentanyl | 5 | 20.00 |
| 4-Fluoro-isobutyrylfentanyl | 50 | 2.00 |
| Para-fluorobutyryl fentanyl | 25 | 4.00 |
| Para-fluoro fentanyl | 25 | 4.00 |
| (±)-3-cis-methyl fentanyl | 50 | 2.00 |
| Carfentanil | 10000 | 0.01 |
| Despropionyl fentanyl (4-ANPP) | 50000 | 0.002 |
| Sufentanil | >10000 | 100000 | 10000 | 100000 | 100000 | 10000 | 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:
| % 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 | 0.28 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.51 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.73 | 1 | 19 | 95 |
| +25% Cutoff | 20 | 1.23 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.48 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.75 | 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.
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.