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.

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.

BioSieve™ Toxismart Reader is a portable fluorescence instrument that is intended for use with the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Fentany] Pro Test Kit. The Reader scans the test cassettes included in the Test Kits and displays the results.

AI/ML Overview

The provided FDA 510(k) summary (K241869) describes the BioSieve™ Fentanyl FIA Home Test Kit, BioSieve™ Fentanyl FIA Pro Test Kit, and BioSieve™ Toxismart Reader. The document focuses on demonstrating substantial equivalence to a predicate device (K240124) and includes details of a lay-user study.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., that the device must meet for clearance. Instead, the performance is demonstrated through a lay-user study, and the implied acceptance is 100% correct results for all tested samples across various concentrations relative to the cutoff.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Lay-user study)
Accuracy at -100% Cutoff (0 ng/mL Fentanyl)	100% correct negative results	100% correct negative results (20/20)
Accuracy at -75% Cutoff (0.248 ng/mL Fentanyl)	100% correct negative results	100% correct negative results (20/20)
Accuracy at -50% Cutoff (0.504 ng/mL Fentanyl)	100% correct negative results	100% correct negative results (20/20)
Accuracy at -25% Cutoff (0.745 ng/mL Fentanyl)	100% correct negative results	100% correct negative results (20/20)
Accuracy at +25% Cutoff (1.267 ng/mL Fentanyl)	100% correct positive results	100% correct positive results (20/20)
Accuracy at +50% Cutoff (1.508 ng/mL Fentanyl)	100% correct positive results	100% correct positive results (20/20)
Accuracy at +75% Cutoff (1.768 ng/mL Fentanyl)	100% correct positive results	100% correct positive results (20/20)
Ease of Instructions	Instructions can be easily followed	All lay users indicated instructions were easily followed
Reading Grade Level (Package Insert)	Less than 8th-grade level	Less than 8th-grade level (via Flesch-Kincaid)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: 140 lay persons (participants). Each participant was provided with 1 blind-labeled sample. The total number of individual urine samples prepared for the study across all concentration levels was $20 \times 7 = 140$ samples.
Data Provenance: The document states "Urine samples were prepared... by spiking fentanyl into drug free-pooled urine specimens." This indicates the samples were laboratory-prepared (spiked) rather than naturally occurring clinical samples. The country of origin for the data is not specified, but the submitter is VivaChek Biotech (Hangzhou) Co., Ltd. from China. The study appears to be prospective in nature, as it involved lay users actively interacting with the device and samples.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not explicitly stated as a panel of experts.
Qualifications of Experts: The ground truth for the fentanyl concentrations in the prepared urine samples was established by LC/MS (Liquid Chromatography/Mass Spectrometry). This is a highly accurate analytical method for quantifying substances, and its operation would typically be performed by trained laboratory personnel/chemists rather than medical experts like radiologists. The document does not specify the qualifications of the individuals who performed the LC/MS analysis. The reference method is considered the "ground truth."

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method involving multiple human readers or a consensus process for the results of the device tests. The lay users performed the tests, and their readings (positive/negative) were compared directly against the LC/MS confirmed concentrations of the spiked samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a lay-user study evaluating the device's performance when used by intended lay users, not a comparison of human readers with and without AI assistance, nor does the device itself involve AI assistance for interpretation beyond the Toxismart Reader's automated reporting.

6. Standalone (Algorithm Only) Performance

Yes, a form of standalone performance was implicitly evaluated. The "lay-user study" assessed the BioSieve™ Fentanyl FIA Home Test Kit and BioSieve™ Toxismart Reader system (which includes interpretation by the reader) in an "algorithm only without human-in-the-loop performance" sense, as the lay users were simply operating the device and reading its output. The reader itself performs the detection and displays the result.

7. Type of Ground Truth Used

The ground truth used was analytical confirmation by LC/MS. This is an objective quantitative method considered highly accurate for determining the precise concentration of fentanyl in the spiked urine samples.

8. Sample Size for the Training Set

The document states: "1. Analytical Performance: See analytical performance in predicate K240124. 2. Comparison Studies: See studies in predicate K240124". This implies that the training (or development/optimization) data for the device's analytical performance and the reader's algorithm were part of the predicate device's submission (K240124) and are not detailed in this 510(k) summary. Therefore, the sample size for the training set is not provided in the current document.

9. How the Ground Truth for the Training Set Was Established

Similar to the above, the methods for establishing ground truth for any training set related to the development of the device or reader would be found in the predicate device's documentation (K240124) and are not detailed in this summary. It can be inferred that for a diagnostic device like this, ground truth would likely involve a combination of spiked samples with known concentrations and potentially confirmed clinical samples using a reference method like GC/MS or LC/MS.

Summary

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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.

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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

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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

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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)

Clinical consideration and professional judgment should be exercised with any drug test result, particularly when the preliminary test 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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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 ZoneHangzhou, Zhejiang, China 311100
3. Contact person:	Jenny XiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 301-525-6856Email:jxia@lsi-consulting.org
4. Device Name:	BioSieve™ Fentanyl FIA Home Test KitBioSieve™ Fentanyl FIA Pro Test KitBioSieve™ Toxismart Reader

Classification: Class II
Product Code	Classification	CFR #	Panel
NGL	II	21 CFR § 862.3650Opiate Test System	Toxicology
KHO	I	21 CFR § 862.2560Fluorometer for clinical use	Clinical Chemistry

Predicate Devices: K240124 BioSieve™ Fentanyl FIA Test Kit

BioSieve™ Toxismart FIA Reader

6. Intended 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 is the preferred confirmatory method.

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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.

1. 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.

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 offentanyl in human urine.	Same
Calibrator and Cut-OffValues	Fentanyl (FTY)1 ng/ml	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	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 forUse	Immunofluorescence analyzer designed toperform in vitro diagnostic tests on clinicalspecimens including drug urine test.	Same
Principles of AssayOperation	Competitive immunofluorescenceimmunoassay	Same
Calibration Check	A Quality control test device is suppliedwith the Reader and used to check theReader optics and calculation systems.	Same
Development Modes	One basic assay development mode:Standard test: In standard test, the userinserts into the Reader immediatelyafter adding the sample, and the Readerwill display the test result when thecountdown is finished.	Two basic assay developmentmodes:Standard test: In standard test,the user inserts into the Readerimmediately after adding thesample, and the Reader willdisplay the test result when thecountdown is finished.Quick test: In the quick test,the user inserts into the Readerafter the reaction time iscompleted, and the Reader willdisplay test results in a fewseconds.
User interface	1.54 inch LCD Screen display	Same
Barcode scanner (sample)	Not equipped with a barcode scanner	Same
Assay/instrumentinterface	Drawer	Same
Light Source	LED Light	Same
Power Supply	Powered by a 3.7V lithium-ion batteryTwo charging methods:1.Type C & USB 2 in 1 cable (computercharging)2.Type C & USB 2 in 1 cable with theAC 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

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1. Analytical Performance: See analytical performance in predicate K240124.
1. Comparison Studies: See studies in predicate K240124
1. 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	Numberofsamples	Fentanyl Concentrationby LC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
			No. ofPositive	No. ofNegative
-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.

1. Clinical Studies
  Not applicable.
1. 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.

Regulation Number and Section

§ 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).