(93 days)
Not Found
No
The device is a lateral flow immunoassay, which is a chemical test, and the summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No.
This device is an in vitro diagnostic device used for the qualitative detection of fentanyl in human urine, providing preliminary test results. It does not provide any therapeutic benefit or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only," which directly indicates it is a diagnostic device.
No
The device description explicitly states it consists of a "Test Dip Card" and a "package insert," which are physical components, not software. The device is a lateral flow immunoassay, a hardware-based diagnostic method.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states:
- "For in vitro diagnostic use only." in the Intended Use / Indications for Use section.
- "It is for in vitro diagnostic use only." in the Intended Use / Indications for Use section.
- "AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine." in the Device Description section, which describes the device's function in testing a biological sample (human urine) outside of the body.
N/A
Intended Use / Indications for Use
AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL.
The test provides 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. For in vitro diagnostic use only.
The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL.
This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is for in vitro diagnostic use only.
Product codes (comma separated list FDA assigned to the subject device)
NGL
Device Description
AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card 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 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
- 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.
- Lot 1: 60-/0+ for -100%, -75%, -50% cut off; 46-/14+ for -25% cutoff; 28+/32- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off.
- Lot 2: 60-/0+ for -100%, -75%, -50% cut off; 44-/16+ for -25% cutoff; 28+/32- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off.
- Lot 3: 60-/0+ for -100%, -75%, -50% cut off; 45-/15+ for -25% cutoff; 30+/30- for cut off; 60+/0- for +25%, +50%, +75%, +100% cut off.
- Stability: The devices are stable at 2-30 ℃ for 24 months based on the accelerated 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 are summarized in the following tables. (Table includes 90+ compounds like Acetaminophen, Acetone, Albumin, Ethanol, Glucose, etc. with no interference)
- 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. (Table includes various fentanyl derivatives like Norfentanyl, Acetyl fentanyl, Acrylfentanyl, etc. and other opioids like 6-Acetyl morphine, Amphetamine, Buprenorphine, etc. with their minimum concentration for positive result or 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.
2. Comparison Studies
Method comparison studies for the AllSource Drug Detector Fentanyl Test were performed at three different testing sites. Operators ran 80 (40 negative and 40 positive) unaltered clinical samples. The samples were blind labeled and compared to LC/MS results.
- Site 1: 0 positive for Low Negative by LC/MS, 4 positive for Near Cutoff Negative, 22 positive for Near Cutoff Positive, 17 positive for High Positive. 10 negative for Low Negative by LC/MS, 9 negative for Near Cutoff Negative, 1 negative for Near Cutoff Positive, 0 negative for High Positive.
- Site 2: 0 positive for Low Negative by LC/MS, 6 positive for Near Cutoff Negative, 21 positive for Near Cutoff Positive, 17 positive for High Positive. 10 negative for Low Negative by LC/MS, 7 negative for Near Cutoff Negative, 2 negative for Near Cutoff Positive, 0 negative for High Positive.
- Site 3: 0 positive for Low Negative by LC/MS, 6 positive for Near Cutoff Negative, 21 positive for Near Cutoff Positive, 17 positive for High Positive. 10 negative for Low Negative by LC/MS, 7 negative for Near Cutoff Negative, 2 negative for Near Cutoff Positive, 0 negative for High Positive.
- Discordant Results: A table lists specific sample numbers with LC-MS/MS results and AllSource results showing some discordant results (e.g., LC-MS/MS result 0.835, AllSource Result Positive; LC-MS/MS result 1.059, AllSource Result Negative). (20 discordant results listed across 3 sites)
3. Lay-user study
A lay user study was performed at three intended user 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%, +/-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.
- -100% Cutoff (0 ng/mL, 20 samples): 0 Positive, 20 Negative. 100% correct.
- -75% Cutoff (0.31 ng/mL, 20 samples): 0 Positive, 20 Negative. 100% correct.
- -50% Cutoff (0.48 ng/mL, 20 samples): 0 Positive, 20 Negative. 100% correct.
- -25% Cutoff (0.77 ng/mL, 20 samples): 5 Positive, 15 Negative. 75% correct.
- +25% Cutoff (1.22 ng/mL, 20 samples): 20 Positive, 0 Negative. 100% correct.
- +50% Cutoff (1.42 ng/mL, 20 samples): 20 Positive, 0 Negative. 100% correct.
- +75% Cutoff (1.78 ng/mL, 20 samples): 20 Positive, 0 Negative. 100% correct.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found (Specific numeric values for sensitivity, specificity, PPV, NPV are not explicitly stated, though raw data for positive/negative results are provided in the performance studies).
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 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.
AllSource Screening Solutions % Joe Shia Director LSI International Inc 504 E Diamond Ave. Gaithersburg, Maryland 20877
Re: K234006
Trade/Device Name: AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL Dated: February 9, 2024 Received: February 12, 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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Joseph A. Digitally signed by Kotarek - S Date: 2024.03.21 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) K234006
Device Name
AllSource Drug Detector FenTest AllSource Drug Detector Fentanyl Test
Indications for Use (Describe)
AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL.
The test provides 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. For in vitro diagnostic use only.
The AllSource Drug Detector Fentany] Test is a rapid, one-step immunoassay for the qualitative detection of fentary] in human urine at the cutoff concentrations of 1 ng/mL.
This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GCMS is the preferred confirmatory method. Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated. It is 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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3
510(k) SUMMARY K234006
- March 7, 2024 1. Date: 2. Submitter: AllSource Screening Solutions 1401 Pontiac Court Export, PA 15632 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com
-
- Device Names: AllSource Drug Detector FenTest AllSource Drug Detector Fentanyl Test
| 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
AllSource Drug Detector FenTest is competitive binding, lateral flow immunochromatographic assay for qualitative detection of Fentanyl in human urine at the cutoff concentrations of 1 ng/mL. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/MS or LC/MS is the preferred confirmatory method.
- Indications for Use
For in vitro diagnostic use only.
The AllSource Drug Detector Fentanyl Test is a rapid, one-step immunoassay for the qualitative detection of fentanyl in human urine at the cutoff concentrations of 1 ng/mL.
This device provides only preliminary drug test results. To obtain a quantitative result or a confirmation of a presumptive positive result, a more specific alternative method must be used. GC/MS or LC/MS is the preferred confirmatory method.
Professional judgment should be applied to drug test results, particularly when preliminary positive results are indicated.
It is for in vitro diagnostic use only.
-
- Device Description
AllSource Drug Detector Fentanyl Test is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllSource Drug Detector Fentanyl Test device consists of a Test Dip Card and a package insert. Each Test Dip Card is sealed with sachets of desiccant in an aluminum pouch.
- Device Description
4
-
- Substantial Equivalence Information
A summary comparison of features of the AllSource Drug Detector Fentanyl Test and the predicate devices is provided in following table.
- Substantial Equivalence Information
Table 1: Features Comparison of AllSource Drug Detector Fentanyl Test and the Predicate Device
| 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 | Dip Card | Cassette |
| Storage | 4-30°C | Same |
-
- Test Principle
AllSource Drug Detector Fentanyl Test is a competitive and immunochromatography assay, and uses monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine. The test cassette contains fentanyl test strip. The nitrocellulose membrane test area (T) of the test strip is correspondingly coated with fentanyl-bovine serum albumin conjugate, and the quality control area (C) is coated with goat anti-rabbit IgG polyclonal antibody. When the concentration of fentanyl in the sample is higher than or equal to the cut-off of the product, it will compete with the corresponding conjugate coated on the test area (T) to bind to the monoclonal antibody, the test line is inhibited and the result is positive; while when the sample does not contain fentanyl or its concentration is lower than the cut-off of the product, the corresponding conjugate on the test line reacts with sufficient monoclonal antibodies, the test line will be visible and the result is negative. No matter whether the sample contains the corresponding analyte or not, the quality control area (C) will develop a colored line, which is the criteria for judging whether the chromatography process is normal or not.
- Test Principle
-
- 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
5
sample testing. For each concentration, tests were performed two tests per day for 10 days per device lot 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+ | 46-/14+ | 28+/32- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 44-/16+ | 28+/32- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 45-/15+ | 30+/30- | 60+/0- | 60+/0- | 60+/0- | 60+/0- |
c. Stability
The devices are stable at 2-30 ℃ 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 (1000mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
| Acetylsalicylic acid | Erythromycin | Octopamine |
| Albumin (100mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline | Furosemide | Oxymetazoline |
| Amobarbital | Galactose (10mg/dL) | Papaverine |
| Amoxicillin | Gamma Globulin (500mg/dL) | Penicillin G |
| Ampicillin | Gentisic acid | Perphenazine |
| Apomorphine | Glucose (3000mg/dL) | Phencyclidine |
| Ascorbic acid | Hemoglobin | Phenelzine |
| Aspartame | Hydralazine | Phenobarbital |
| Atropine | Hydrochlorothiazide | Prednisone |
| Benzilic acid | Hydrocortisone | Propoxyphene (50ug/ml) |
| Benzoic acid | Hydroxytyramine | Propranolol |
| Benzoylecgonine | Ibuprofen | Pseudoephedrine |
| Bilirubin | Imipramine | Quinine |
| Boric Acid (1%) | Isoproterenol | Ranitidine |
| Bupropion | Isoxsuprine | Riboflavin (10mg/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 |
6
| Creatinine | Metronidazole (300ug/ml) | Trifluoperazine |
|---|---|---|
| Cyclobenzaprine | N-Acetylprocainamide | Trimethoprim |
| Deoxycorticosterone | NaCl (4000mg/dL) | Tyramine |
| Desipramine | Nalidixic acid | Urea (2000mg/dL) |
| Dextromethorphan | Naloxone | Uric acid |
| Diclofenac | Naltrexone | Valproic acid (250ug/ml) |
| Diflunisal | Naproxen | Venlafaxine |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine | Zomepirac |
| DL-Tryptophan | Nifedipine | ß-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 |
|------------------------------------|-----------------------------------------------------------------------------|--------------------|
| Norfentanyl | 50 | 2% |
| Acetyl fentanyl | 1 | 100% |
| Acrylfentanyl | 10 | 10% |
| Isobutyryl fentanyl | 2.5 | 40% |
| Ocfentanil | 10 | 10% |
| Butyryl fentanyl | 2.5 | 40% |
| Furanyl fentanyl | 7.5 | 13.3% |
| Valeryl fentanyl | 10 | 10% |
| (±) β-hydroxythiofentanyl | 5 | 20% |
| Para-fluorobutyrylfentanyl (p-FBF) | 10 | 10% |
| Para-fluoro fentanyl | 1 | 100% |
| (±)-3-cis-methylfentanyl | 10 | 10% |
| Carfentanil | 10000 | 0.01% |
| Sufentanil | 10000 | 0.01% |
| Norcarfentanil | 100000 | 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 | 0.31 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.48 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.77 | 5 | 15 | 75 |
| +25% Cutoff | 20 | 1.22 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.42 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.78 | 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
9
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.