(342 days)
Not Found
No
The description details a standard immunoassay and a fluorescence analyzer that reads the results. There is no mention of AI/ML in the device description, intended use, or performance studies. The analysis is based on the presence or absence of fluorescence signals at specific locations on the test strip, which is a deterministic process, not one involving learning or complex pattern recognition typically associated with AI/ML in medical devices.
No.
The device is an in vitro diagnostic device used for the qualitative detection of fentanyl in human urine, which provides preliminary test results. It does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is for prescription use only." This directly indicates its purpose as a diagnostic tool.
No
The device description clearly outlines a physical test strip and an "Immunofluorescence Analyzer EASY-11" which is described as a "portable fluorescence instrument". This indicates the device includes significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "This in vitro diagnostic device is for prescription use only."
- Intended Use: The device is intended for the qualitative detection of fentanyl in human urine, which is a clinical specimen. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for clinical purposes.
- Device Description: The description details a test that analyzes a human urine sample using a lateral flow immunoassay. This is a common method used in IVD tests.
- Associated Analyzer: The device is intended for use with the Superbio Immunofluorescence Analyzer EASY-11, which is also described as being "for in vitro diagnostic use only."
- Performance Studies: The document describes various performance studies (precision, stability, interference, specificity, comparison studies) which are typical evaluations performed for IVD devices to demonstrate their analytical and clinical performance.
- Predicate Devices: The document lists predicate devices with K numbers, which are FDA clearance numbers for medical devices, including IVDs.
All of these factors clearly indicate that the Superbio Fentanyl Urine Detection Kit is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only.
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.
The Superbio Immunofluorescence Analyzer EASY-11 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or in a point-of-care setting.
Product codes
DJG, KHO
Device Description
This test uses a lateral flow design with location-dependent lines and zones. The Immunofluorescence Analyzer EASY-11 scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad.
Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the detection limit, the antigen in the sample and the fluorescence-labeled antibody bind to the FTY antigen-antibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line and the antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures no fluorescence signal. When the samples do not contain fentanyl antigen or levels below the detection limit, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of sheep antirabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.
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
This in vitro diagnostic device is for prescription use only.
This analyzer can be used in a laboratory or in a point-of-care setting.
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, +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 six runs per day for 10 days per device lot in a randomized order. Each device was read on one Superbio Immunofluorescence Analyzer EASY-11.
- Lot 1:
- -100% cut off: 60-/0+
- -75% cut off: 60-/0+
- -50% cut off: 60-/0+
- -25% cutoff: 56-/4+
- cut off: 27-/33+
- +25% cut off: 56+/4-
- +50% cut off: 60+/0-
- +75% cut off: 60+/0-
- +100% cut off: 60+/0-
- Lot 2:
- -100% cut off: 60-/0+
- -75% cut off: 60-/0+
- -50% cut off: 60-/0+
- -25% cutoff: 57-/3+
- cut off: 32-/28+
- +25% cut off: 57+/3-
- +50% cut off: 60+/0-
- +75% cut off: 60+/0-
- +100% cut off: 60+/0-
- Lot 3:
- -100% cut off: 60-/0+
- -75% cut off: 60-/0+
- -50% cut off: 60-/0+
- -25% cutoff: 56-/4+
- cut off: 27-/33+
- +25% cut off: 55+/5-
- +50% cut off: 60+/0-
- +75% cut off: 60+/0-
- +100% cut off: 60+/0-
- Lot 1:
- Stability: The devices are stable at 4-30 ℃ for 12 months based on the accelerated stability study at 45 °C. The real time stability study is ongoing.
- 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 tables.
- 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 with their % Cross-Reactivity. For example, Norfentanyl showed 0.01% cross-reactivity at 10000 ng/mL, while Acetyl fentanyl showed 83.33% cross-reactivity at 1.20 ng/mL. Many opioid compounds were tested at 100ug/mL (or specified concentrations for some) and yielded 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 fentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots of the device. All results were positive for samples at and above +50% Cut-Off and all negative for samples at and below -50% Cut-Off.
Comparison Studies
Method comparison studies for the Superbio Fentanyl Urine Detection Kit 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:
- Positive results: 0 (Negative), 0 (Low Negative), 3 (Near Cutoff Negative), 21 (Near Cutoff Positive), 16 (High Positive)
- Negative results: 7 (Negative), 17 (Low Negative), 13 (Near Cutoff Negative), 3 (Near Cutoff Positive), 0 (High Positive)
- Site 2:
- Positive results: 0 (Negative), 0 (Low Negative), 3 (Near Cutoff Negative), 21 (Near Cutoff Positive), 16 (High Positive)
- Negative results: 7 (Negative), 17 (Low Negative), 13 (Near Cutoff Negative), 3 (Near Cutoff Positive), 0 (High Positive)
- Site 3:
- Positive results: 0 (Negative), 0 (Low Negative), 3 (Near Cutoff Negative), 22 (Near Cutoff Positive), 16 (High Positive)
- Negative results: 7 (Negative), 17 (Low Negative), 13 (Near Cutoff Negative), 2 (Near Cutoff Positive), 0 (High Positive)
Discordant Results (Sample Number, LC/MS Result, SUPERBIO Results)
- Site 1: FM015 (0.984, Positive), FM026 (0.866, Positive), FM058 (0.921, Positive), FM031 (1.05, Negative), FM051 (1.18, Negative), FM065 (1.07, Negative)
- Site 2: FM012 (0.833, Positive), FM015 (0.984, Positive), FM026 (0.866, Positive), FM013 (1.09, Negative), FM074 (1.1, Negative), FM098 (1.14, Negative)
- Site 3: FM012 (0.833, Positive), FM016 (0.953, Positive), FM032 (0.815, Positive), FM065 (1.07, Negative), FM091 (1.12, Negative)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
December 13, 2022
Shenzhen Superbio Technology Co., Ltd. % Joe Shia, Director LSI 504 E Diamond Ave., Suite I Gaithersburg, MD 20877
Re: K220046
Trade/Device Name: Superbio Fentany] Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, KHO Dated: August 29, 2022 Received: August 29, 2022
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 (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 located 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 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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Paula Paula Caposino -S Caposino -S Date: 2022.12.13
17:19:25 -05'00'
Paula V. Caposino, Ph.D. Acting Deputy Director 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
510(k) Number (if known) K220046
Device Name Superbio Fentanyl Urine Detection Kit Superbio Immunofluorescence Analyzer EASY-11
Indications for Use (Describe)
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only.
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.
The Superbio Immunofluorescence Analyzer EASY-11 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or in a point-of-care setting.
| 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 K220046
-
- Date: December 2, 2022 2. Submitter: Shenzhen Superbio Technology Co., Ltd. Building B. Xinzheng, 71 Area, Xinan Sub-District, Baoan Shenzhen, China 518101 3. Contact person: Joe Shia LSI International Inc. 504E Diamond Ave., Suite I Gaithersburg, MD 20877 Telephone: 240-505-7880 Email: shiajl@yahoo.com 4. Device Names: Superbio Fentanyl Urine Detection Kit Superbio Immunofluorescence Analyzer EASY-11
| Classification: | Class 2 | ||
|---|---|---|---|
| Product Code | Classification | Regulation Section | Panel |
| DJG | II | 21 CFR § 862.3650 | |
| Opiate Test System | Toxicology (91) | ||
| KHO | I | 21 CFR § 862.2560 | |
| Fluorometer for clinical use | Clinical Chemistry |
-
- Indications for Use
The Superbio Fentanyl Urine Detection Kit is a fluorescence immunoassay intended for the qualitative detection of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with Superbio Immunofluorescence Analyzer EASY-11. This in vitro diagnostic device is for prescription use only.
- Indications for Use
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.
The Superbio Immunofluorescence Analyzer EASY-11 is a portable fluorescence instrument for in vitro diagnostic use only. The analyzer is designed to perform in vitro diagnostic tests on clinical specimens. This analyzer can be used in a laboratory or in a point-of-care setting.
-
- Device Description
This test uses a lateral flow design with location-dependent lines and zones. The Immunofluorescence Analyzer EASY-11 scans the test strip and displays results. The sample is added to the sample well of the test card, and the sample is drawn by capillary action into and through the fluorescent labeled pad, through the nitrocellulose strip and into the adsorption pad.
- Device Description
4
Within the fluorescent labeled pad, the specimen comes into contact with antibodies conjugated with fluorescent microspheres. During this interaction, if the amount of fentanyl antigen in the sample is greater than or equal to the detection limit, the antigen in the sample and the fluorescencelabeled antibody bind to the FTY antigen-antibody complex when the sample passes through a pad of fluorescence-microbead-labeled antibody conjugate. As the sample flows and reaches the FTY antigen coated by the T-line of nitrocellulose membrane, the FTY antigen coated by the T-line and the antigen in the sample competitively bind the FTY antibody labeled with fluorescence, then the T-line captures no fluorescence signal. When the samples do not contain fentanyl antigen or levels below the detection limit, as the sample flow, fluorescent microsphere labeled antibody to nitrocellulose membrane T line captures fluorescent signal. Whether or not FTY antigen was present in the sample, the rabbit IgG fluorescent microsphere conjugate not bound to the test line continued to flow with the rest of the sample and soon encountered a control line composed of sheep antirabbit IgG. The position of C-line will accumulate fluorescence signal. The C-line control area was scanned to confirm that adequate sample flow had occurred. High resolution, narrow band SMD LED was used as light source in the Immunofluorescence Analyzer. The central wavelength of the excitation spectrum is 365nm. The central response wavelength is 610nm.
-
- Substantial Equivalence Information
A summary comparison of features of the Superbio Fentanyl Urine Detection Kit and the predicate devices is provided in following table.
- Substantial Equivalence Information
| Item | Device | Predicate - K180427 |
|---|---|---|
| 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. | Homogenous enzyme | |
| immunoassay | ||
| (EIA) | ||
| Type of Test | Qualitative | Same |
| Specimen Type | Human Urine | Same |
| Intended Use | For prescription use | Same |
| Configurations | Dip Card and Strip | Cup |
| Platform Required | Immunofluorescence Analyzer | Automated clinical chemistry |
| analyzer | ||
| Storage | 4-30°C | 2-8°C |
Table 1: Features Comparison of Superbio Fentanyl Urine Detection Kit and the Predicate Devices
Table 2: Instrument Similarities and Differences
| Item | Predicate - K973547 | Subject Device |
|---|---|---|
| Intended Use/ | ||
| Indication for Use | Immunofluorescence analyzer | |
| designed to perform in vitro | ||
| diagnostic tests on clinical specimens | ||
| including drug urine test. | Same | |
| Principles of Assay | ||
| Operation | Sandwich immunofluorescence | |
| immunoassay | Same | |
| Calibration Check | Run two levels or POS and NEG external | |
| liquid control samples as appropriate with | ||
| each new lot of reagents and once every | ||
| 30 days with continued use of the same | ||
| reagent lot number | A Quality control card is supplied | |
| with Easy-11 and used for check | ||
| Easy-11 optics and calculation. | ||
| systems. | ||
| Development Modes | one test mode | |
| • Run Test | Two basic assay development | |
| modes: | ||
| • Standard test: In standard test, the | ||
| user immediately inserts Test | ||
| Cassette into Easy-11 and click | ||
| "start test". Easy-11 automatically | ||
| counts the time. | ||
| • Quick test: Manually timing, then | ||
| insert the test card into Easy-11, and | ||
| click "Start Test". The instrument | ||
| will read the results. | ||
| User interface | 4 inch LCD Screen display | 8 inch Color LCD touchscreen |
| display | ||
| Barcode scanner | ||
| (sample) | External Barcode Scanner (optional) | Same |
| Assay/instrument | ||
| interface | Drawer | Same |
| Light Source | Laser Diode | LED Light |
| Power Supply | 6v DC at 1 amp – supplied via 4 AA | |
| batteries or AC/DC Converter | AC100-240V | |
| Dimensions | 22.5 cm x 19 cm x 7 cm | 24.5 cm x 27 cm x 16 cm |
| Weight | ~1.5 lbs | ~4.5 lbs |
5
-
- Test Principle
Superbio Fentanyl Urine Detection Kit is a competitive and fluorescence immunochromatography assay, and uses fluorescence microspheres-labeled monoclonal antibody as the indicator marker to qualitatively detect fentanyl in human urine.
- Test Principle
6
The test card 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. Both Fentanyl monoclonal antibody and rabbit IgG polyclonal antibody labeled with fluorescent microspheres were embedded on the conjugate pad. When the concentration of fentany] 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 fluorescently-labeled monoclonal antibody, the fluorescence rendering of 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 fluorescently-labeled monoclonal antibodies, the test line will have fluorescence and the result is negative. No matter whether the sample contains the corresponding analyte or not, the quality control area (C) will develop fluorescence, which is the criteria for judging whether the chromatography process is normal or not. The test card is tested by the Superbio Immunofluorescence Analyzer EASY-11 and the results are interpreted by the analyzer.
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, +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 six runs per day for 10 days per device lot in a randomized order. Each device was read on one Superbio Immunofluorescence Analyzer EASY-11. The results obtained are summarized in the following tables.
| 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+ | 56-/4+ | 27-/33+ | 56+/4- | 60+/0- | 60+/0- | 60+/0- |
| Lot 2 | 60-/0+ | 60-/0+ | 60-/0+ | 57-/3+ | 32-/28+ | 57+/3- | 60+/0- | 60+/0- | 60+/0- |
| Lot 3 | 60-/0+ | 60-/0+ | 60-/0+ | 56-/4+ | 27-/33+ | 55+/5- | 60+/0- | 60+/0- | 60+/0- |
c. Stability
The devices are stable at 4-30 ℃ for 12 months based on the accelerated stability study at 45 °C. The real time stability study is ongoing.
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 (50ug/ml) | Nortriptyline (25ug/ml) |
|---|---|---|
| Acetone (1000mg/dL) | Ecgonine methyl ester | Noscapine |
| Acetophenetidin | Ephedrine | O-Hydroxyhippuric acid |
7
| Acetylsalicylic acid | Erythromycin | Octopamine |
|---|---|---|
| Albumin (100mg/dL) | Ethanol (1%) | Oxalic acid (100 mg/dL) |
| Albuterol | Fenoprofen | Oxazepam |
| Aminopyrine | Fluphenazine | Oxolinic acid |
| Amitriptyline (35ug/ml) | 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 (30ug/ml) | Quinine |
| Boric Acid (1%) | Isoproterenol | Ranitidine |
| Bupropion (50ug/ml) | Isoxsuprine | Riboflavin (7.5mg/dL) |
| Caffeine | Ketamine | Salicylic acid |
| Carbamazepine | Ketoprofen | Secobarbital |
| Chloral hydrate | Labetalol | Serotonin (5-Hydroxytyramine) |
| Chloramphenicol | Lidocaine (50ug/ml) | Sulfamethazine |
| Chlorothiazide | Loperamide | Sulindac |
| Chlorpromazine | Maprotiline (50ug/ml) | Tetrahydrocortisone 3-(β- Dglucuronide) |
| Cholesterol | Meperidine | Tetrahydrocortisone 3-acetate |
| Clomipramine (50ug/ml) | Meprobamate | Tetrahydrozoline |
| Clonidine | Methapyrilene (10ug/ml) | Thiamine |
| Cortisone | Methaqualone (50ug/ml) | Thioridazine |
| Cotinine | Methoxyphenamine | Triamterene |
| Creatinine | Metronidazole (300ug/ml) | Trifluoperazine |
| Cyclobenzaprine | ||
| (10ug/ml) | N-Acetylprocainamide | Trimethoprim |
| Deoxycorticosterone | NaCl (4000mg/dL) | Tyramine |
| Desipramine (50ug/ml) | Nalidixic acid | Urea (2000mg/dL) |
| Dextromethorphan | Naloxone | Uric acid |
| Diclofenac | Naltrexone | Valproic acid (250ug/ml) |
| Diflunisal | Naproxen | Venlafaxine |
| Digoxin | Niacinamide | Verapamil |
| Diphenhydramine | Nicotine (10ug/ml) | Zomepirac |
| DL-Tryptophan | Nifedipine | β-Estradiol |
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 | 10000 | 0.01 |
| Acetyl fentanyl | 1.20 | 83.33 |
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| Acrylfentanyl | 1.20 | 83.33 |
|---|---|---|
| ω-1-Hydroxyfentanyl | 20000 | 0.005 |
| Isobutyryl fentanyl | 1.50 | 66.67 |
| Ocfentanil | 1.50 | 66.67 |
| Butyryl fentanyl | 1.60 | 62.50 |
| Furanyl fentanyl | 1.75 | 57.14 |
| Valeryl fentanyl | 2.50 | 40.00 |
| (±) β-hydroxythiofentanyl | 2.80 | 35.71 |
| 4-Fluoro-isobutyrylfentanyl | 3.00 | 33.33 |
| Para-fluorobutyrylfentanyl (p-FBF) | 3.00 | 33.33 |
| Para-fluoro fentanyl | 3.00 | 33.33 |
| (±)-3-cis-methylfentanyl | 5.00 | 20.00 |
| Carfentanil | 500 | 0.20 |
| Sufentanil | 625 | 0.16 |
| Acetyl norfentanyl | 10,000 | 0.01 |
The following opioids compounds were tested at a concentration of 100ug/mL (despropionyl fentanyl (4-ANPP) was tested at 50 ug/mL, norcarfentanil was tested at 5 ug/mL and remifentanil was tested at 10 ug/mL). Negative results were obtained for all these compounds. There is no cross-reactivity for these compounds using the Superbio Fentanyl Urine Detection Kit
| 6-Acetyl morphine | Naltrexone |
|---|---|
| Amphetamine | Norbuprenorphine |
| Buprenorphine | Norcodeine |
| Buprenorphineglucuronide | Norketamine |
| Codeine | Normeperidine |
| Dextromethorphan | Normorphine |
| Dihydrocodeine | Noroxycodone |
| EDDP | Oxycodone |
| EMDP | Oxymorphone |
| Fluoxetine | Pentazocine (Talwin) |
| Heroin | Pipamperone |
| Hydrocodone | Risperidone |
| Hydromorphone | Tapentadol |
| Ketamine | Thioridazine |
| Levorphanol | Tilidine |
| Meperidine | Tramadol |
| Methadone | Tramadol-O- Desmethyl |
| Morphine | Tramadol-N- Desmethyl |
| Morphine-3-glucuronide | Trazodone |
| Naloxone | Alfentanil |
| Despropionyl fentanyl (4-ANPP) (50 ug/mL) | Norcarfentanil (5 ug/mL) |
| Norcarfentanil (10 ug/mL) |
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 target fentanyl at 50% below and 50% above Cut-Off levels. These samples were tested using three lots
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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 Superbio Fentanyl Urine Detection Kit 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 are presented in the tables below.
| | | Negative | Low Negative by
LC/MS
(less than
-50%) | Near Cutoff
Negative by
LC/MS
(Between
-50% and
cutoff) | Near Cutoff
Positive by
LC/MS
(Between the
cutoff and
+50%) | High Positive
by LC/MS
(greater than
+50%) |
|-----------|----------|----------|-------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Site
1 | Positive | 0 | 0 | 3 | 21 | 16 |
| | Negative | 7 | 17 | 13 | 3 | 0 |
| Site
2 | Positive | 0 | 0 | 3 | 21 | 16 |
| | Negative | 7 | 17 | 13 | 3 | 0 |
| Site
3 | Positive | 0 | 0 | 3 | 22 | 16 |
| | Negative | 7 | 17 | 13 | 2 | 0 |
Discordant Results
| Operator | Sample Number | LC/MS Result | SUPERBIO
Results |
|----------|---------------|--------------|---------------------|
| Site 1 | FM015 | 0.984 | Positive |
| Site 1 | FM026 | 0.866 | Positive |
| Site 1 | FM058 | 0.921 | Positive |
| Site 1 | FM031 | 1.05 | Negative |
| Site 1 | FM051 | 1.18 | Negative |
| Site 1 | FM065 | 1.07 | Negative |
| Site 2 | FM012 | 0.833 | Positive |
| Site 2 | FM015 | 0.984 | Positive |
| Site 2 | FM026 | 0.866 | Positive |
| Site 2 | FM013 | 1.09 | Negative |
| Site 2 | FM074 | 1.1 | Negative |
| Site 2 | FM098 | 1.14 | Negative |
| Site 3 | FM012 | 0.833 | Positive |
| Site 3 | FM016 | 0.953 | Positive |
| Site 3 | FM032 | 0.815 | Positive |
| Site 3 | FM065 | 1.07 | Negative |
| Site 3 | FM091 | 1.12 | Negative |
-
- Clinical Studies
Not applicable.
- Clinical Studies
-
- Conclusion
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Based on the test principle and acceptable performance characteristics including precision, cut-off, interference, specificity, and method comparison studies of the devices, it's concluded a substantial equivalence decision.