(99 days)
No
The document describes a fluorescence immunoassay test kit and a reader that scans the test cassettes and displays results. There is no mention of AI or ML in the intended use, device description, or performance studies. The reader appears to be a simple instrument for reading fluorescence signals, not for complex data analysis or pattern recognition typically associated with AI/ML.
No.
The device is an in vitro diagnostic (IVD) device used for the qualitative determination of fentanyl in human urine, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "BioSieve™ Fentanyl FIA Pro Test Kit... It is for in vitro diagnostic use only." and "BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only."
No
The device description explicitly states that the BioSieve™ Toxismart Reader is a "portable fluorescence instrument" and that the test kits are "physical devices." This indicates the presence of 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 for the BioSieve™ Fentanyl FIA Pro Test Kit and the BioSieve™ Toxismart Reader explicitly states "It is for in vitro diagnostic use only." and "for in vitro diagnostic use only" respectively.
- Nature of the Test: The device performs a test on a biological sample (human urine) outside of the body to determine the presence of a substance (fentanyl). This is the core definition of an in vitro diagnostic test.
- Purpose: The test is intended to provide information about the presence of fentanyl in a person's system, which is a diagnostic purpose.
While the BioSieve™ Fentanyl FIA Home Test Kit doesn't explicitly state "in vitro diagnostic use only" in its intended use, its function and the fact that it's used with the BioSieve™ Toxismart Reader (which is explicitly an IVD) strongly indicate that it is also an IVD. The "Home Test Kit" designation refers to the intended user/care setting (Over-The-Counter Use), not a different type of diagnostic test.
N/A
Intended Use / Indications for Use
BioSieve™ Fentanyl FIA Home Test Kit
BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.
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.
BioSieve™ Fentanyl FIA Pro Test Kit
BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only.
The tests provide only preliminary results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
BioSieve™ Toxismart Reader
BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.
Product codes
NGL, KHO
Device Description
BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch.
BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] FIA Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
BioSieve™ Fentanyl FIA Home Test Kit: Home setting, Over-The-Counter Use
BioSieve™ Fentanyl FIA Pro Test Kit: For in vitro diagnostic use only (professional use implied)
BioSieve™ Toxismart Reader: 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
A lay user study was performed at three intended user sites with 140 lay persons. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Lay-user study:
Sample size: 140 lay persons.
Sample concentrations tested (Fentanyl Concentration by LC/MS in ng/mL): 0, 0.248, 0.504, 0.745, 1.267, 1.508, 1.768.
Key Results:
- For -100% (0 ng/mL), -75% (0.248 ng/mL), -50% (0.504 ng/mL), -25% (0.745 ng/mL) of cutoff, 100% negative results (20 samples each).
- For +25% (1.267 ng/mL), +50% (1.508 ng/mL), +75% (1.768 ng/mL) of cutoff, 100% positive results (20 samples each).
- The percentage of correct results was 100% for all concentration levels tested.
- Lay-users indicated that the device instructions can be easily followed. A Flesch-Kincaid reading analysis of the package insert scored a reading grade level of less than 8.
Analytical Performance and Comparison Studies: See analytical performance and studies in predicate K240124.
Clinical Studies: Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Based on the lay-user study, for the samples tested, the device demonstrated 100% correct results across all fentanyl concentrations relative to the cutoff, indicating high accuracy in this specific study.
- For samples below the cutoff (0 ng/mL, 0.248 ng/mL, 0.504 ng/mL, 0.745 ng/mL), 100% were correctly identified as negative.
- For samples above the cutoff (1.267 ng/mL, 1.508 ng/mL, 1.768 ng/mL), 100% were correctly identified as positive.
Predicate Device(s)
K240124 BioSieve™ Fentanyl FIA Test Kit
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 shows 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 is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
VivaChek Biotech (Hangzhou) Co., Ltd % Jenny Xia LSI International Inc 504E Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K241869
Trade/Device Name: BioSieve™ Fentanyl FIA Home Test Kit; BioSieve™ Fentanyl FIA Pro Test Kit; BioSieve™ Toxismart Reader Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: NGL; KHO Dated: June 27, 2024 Received: June 27, 2024
Dear Jenny Xia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2024.10.04 13:18:32 -04'00'
Joseph Kotarek, PhD Toxicology Branch Chief Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241869
Device Name BioSieve™ Fentanyl FIA Home Test Kit BioSieve™ Fentanyl FIA Pro Test Kit BioSieve™ Toxismart Reader
Indications for Use (Describe)
BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.
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.
BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader. It is for in vitro diagnostic use only.
The tests provide only preliminary results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method.
Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.
| 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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510(k) SUMMARY K241869
| 1. Date: | September 27, 2024 |
|---|---|
| 2. Submitter: | VivaChek Biotech (Hangzhou) Co., Ltd. |
| Level 2, Block 2, 146 East Chaofeng Rd. | |
| Yuhang Economy Development Zone | |
| Hangzhou, Zhejiang, China 311100 | |
| 3. Contact person: | Jenny Xia |
| LSI International Inc. | |
| 504 East Diamond Ave., Suite H | |
| Gaithersburg, MD 20877 | |
| Telephone: 301-525-6856 | |
| Email:jxia@lsi-consulting.org | |
| 4. Device Name: | BioSieve™ Fentanyl FIA Home Test Kit |
| BioSieve™ Fentanyl FIA Pro Test Kit | |
| BioSieve™ Toxismart Reader |
| Classification: Class II | |||
|---|---|---|---|
| Product Code | Classification | CFR # | Panel |
| NGL | II | 21 CFR § 862.3650 | |
| Opiate Test System | Toxicology | ||
| KHO | I | 21 CFR § 862.2560 | |
| Fluorometer for clinical use | Clinical Chemistry |
- Predicate Devices: K240124 BioSieve™ Fentanyl FIA Test Kit
BioSieve™ Toxismart FIA Reader
6. Intended Use:
BioSieve™ Fentanyl FIA Home Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.
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 is the preferred confirmatory method.
5
BioSieve™ Fentanyl FIA Pro Test Kit is a fluorescence immunoassay (FIA) for the qualitative determination of fentanyl in human urine at a cutoff concentration of 1.0 ng/mL. The assay is intended for use with BioSieve™ Toxismart Reader.
It is for in vitro diagnostic use only.
The tests provide only preliminary results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC/MS-MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test result is positive.
BioSieve™ Toxismart Reader is a portable fluorescence instrument for in vitro diagnostic use only. The Reader is designed to perform in vitro diagnostic tests on urine specimens. This Reader is intended for OTC use.
-
- Device Description:
BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit are immunoassays intended for the qualitative detection of fentanyl in human urine. These candidate test kits are the same physical devices as the predicate device cleared in K240124. Each BioSieve™ Fentanyl Test Kit consists of a test cassette and a package insert. Each test cassette is sealed with sachets of desiccant in an aluminum pouch.
- Device Description:
BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] FIA Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.
8. Substantial Equivalence Information
Table 1: Features Comparison of BioSieve™ Fentanyl FIA Home/Pro Test Kit to the Predicate Device
| Item | Device | Predicate - K240124 |
|---|---|---|
| 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 |
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| Type of Test | Qualitative | Same |
|---|---|---|
| Specimen Type | Human Urine | Same |
| Intended Use | Over-The-Counter Use | For prescription use |
| Configurations | Cassette | Same |
| Storage | 2-30°C | Same |
Table 2: Features Comparison of BioSieve™ Toxismart Reader to the Predicate Device
| Item | Device | Predicate - K240124 |
|---|---|---|
| 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 | Competitive immunofluorescence | |
| immunoassay | Same | |
| Calibration Check | A Quality control test device is supplied | |
| with the Reader and used to check the | ||
| Reader optics and calculation systems. | Same | |
| Development Modes | One basic assay development mode: | |
| Standard test: In standard test, the user | ||
| inserts into the Reader immediately | ||
| after adding the sample, and the Reader | ||
| will display the test result when the | ||
| countdown is finished. | Two basic assay development | |
| modes: | ||
| Standard test: In standard test, | ||
| the user inserts into the Reader | ||
| immediately after adding the | ||
| sample, and the Reader will | ||
| display the test result when the | ||
| countdown is finished. | ||
| Quick test: In the quick test, | ||
| the user inserts into the Reader | ||
| after the reaction time is | ||
| completed, and the Reader will | ||
| display test results in a few | ||
| seconds. | ||
| User interface | 1.54 inch LCD Screen display | Same |
| Barcode scanner (sample) | Not equipped with a barcode scanner | Same |
| Assay/instrument | ||
| interface | Drawer | Same |
| Light Source | LED Light | Same |
| Power Supply | Powered by a 3.7V lithium-ion battery | |
| Two charging methods: | ||
| 1.Type C & USB 2 in 1 cable (computer | ||
| charging) | ||
| 2.Type C & USB 2 in 1 cable with the | ||
| AC adapter (wall charging) | ||
| Input: 100-240V~, 50/60Hz, 0.2A Max; | ||
| Output: 5.0V=, 1.0A | Same | |
| Dimensions | 12.45 cm x 7.25 cm x 4 cm | Same |
| Weight | ~0.36 lbs | Same |
| Bluetooth | Disabled | Enabled |
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9. Test Principle
BioSieve™ Fentanyl Test Kit uses the principle of competitive and fluorescence immunochromatography assay. 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 lgG polyclonal antibody. Both Fentanyl monoclonal antibody and rabbit lgG polyclonal antibody labeled with fluorescent microspheres were embedded on the conjugate pad. The labeled antibody will flow forward with the sample, when the urine sample is applied to the sample well of the test device. When the concentration of fentanyl 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 signal 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 fluorescent-labeled monoclonal antibodies, the test line will have fluorescence signal and the result is negative. The quality control area (C) will develop fluorescence signal, which is the criteria for judging whether the test process is normal or not. Signal intensity of fluorescence is detected by BioSieve™ ToxiSmart Reader.
10. Performance Characteristics
8
-
- Analytical Performance: See analytical performance in predicate K240124.
-
- Comparison Studies: See studies in predicate K240124
-
- 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. 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 | 0.248 | 0 | 20 | 100 |
| -50% Cutoff | 20 | 0.504 | 0 | 20 | 100 |
| -25% Cutoff | 20 | 0.745 | 0 | 20 | 100 |
| +25% Cutoff | 20 | 1.267 | 20 | 0 | 100 |
| +50% Cutoff | 20 | 1.508 | 20 | 0 | 100 |
| +75% Cutoff | 20 | 1.768 | 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 8.
-
- Clinical Studies
Not applicable.
- Clinical Studies
-
- Conclusion
Based on the test principle and performance characteristics of the device, it's concluded that BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentanyl FIA Pro Test Kit and BioSieve™ Toxismart Reader are substantially equivalent to the predicate.
- Conclusion