AllTest Fentanyl Urine Test Cassette is 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.

Device Description

AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the AllTest Fentanyl Urine Test Cassette, based on the provided FDA 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on the lay user study demonstrating accurate detection of fentanyl at various concentrations relative to the 1 ng/mL cutoff. The reported device performance is indicated by the percentage of correct results from the lay user study, demonstrating high accuracy across different spiked concentrations.

Acceptance Criteria (Implicit)	Reported Device Performance (Lay User Study)
Ability to correctly identify negative samples at various concentrations below cutoff (e.g., -100%, -75%, -50%, -25% of cutoff)	100% correct for -100%, -75%, -50% cutoff samples; 95% correct for -25% cutoff samples.
Ability to correctly identify positive samples at various concentrations above cutoff (e.g., +25%, +50%, +75% of cutoff)	100% correct for +25%, +50%, +75% cutoff samples.
Ease of understanding package insert instructions by lay users.	All lay users indicated instructions were easily followed. Flesch-Kincaid score < 7.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: 140 lay persons participated in the study. Each participant tested one sample, resulting in 140 test results. The samples were prepared at 7 different concentrations, with 20 samples per concentration level.
- Data Provenance: The data provenance is not explicitly stated as a country of origin for the prepared samples or participants. The study was performed "at three intended user sites," implying it was conducted specifically for this application, making it a prospective study. The samples were "spiked fentanyl into drug free-pooled urine specimens."
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not specify the number or qualifications of experts used to establish the ground truth for the test set.
- The ground truth for the prepared samples was confirmed by LC/MS (Liquid Chromatography-Mass Spectrometry). This is a highly accurate analytical method, which serves as the gold standard for confirming drug concentrations.
Adjudication Method for the Test Set:
- No adjudication method (e.g., 2+1, 3+1) was explicitly performed for the lay user results. The results are reported directly from the lay person's interpretation.
- However, the ground truth of the samples was established by LC/MS, acting as the definitive reference.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. A traditional MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed. This device is a standalone diagnostic test, not an AI-powered image analysis tool. The lay user study focused on the device's performance when used by individuals with no special training.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, in essence, the "algorithm" is the test cassette itself. The lay user study is testing the standalone performance of the device when used by a lay person, without expert intervention or interpretation during the test execution. The accuracy of the device's output is directly assessed against the LC/MS confirmed concentrations.
The Type of Ground Truth Used:
- The ground truth for the test samples was LC/MS confirmation. This is a highly reliable and recognized analytical method for determining drug concentrations.
The Sample Size for the Training Set:
- The document does not provide details about a specific "training set" for the device itself or any underlying machine learning model. This is an immunoassay device, not typically requiring a training set in the context of AI/ML. The analytical performance (sensitivity, specificity, etc.) would have been established through laboratory studies, but specific training set details for those are not given here. The document states: "See analytical performance in predicate K231698," implying that foundational analytical characteristics were established elsewhere.
How the Ground Truth for the Training Set Was Established:
- As no specific "training set" for an AI/ML model is mentioned, this question is not directly applicable. For the analytical performance mentioned, it would typically be established using known, precisely prepared samples with confirmed concentrations (similar to the LC/MS confirmation for the lay user study samples).

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

Hangzhou AllTest Biotech Co.,Ltd % Joe Shia Director LSI International, Inc. 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877

Re: K233417

Trade/Device Name: AllTest Fentanyl Urine Test Cassette Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: Class II Product Code: NGL Dated: October 6, 2023 Received: October 10, 2023

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).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Joseph A. Joseph A. Kotarek -S Kotarek -S Date: 2023.10.26

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

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Indications for Use

Submission Number (if known)

K233417

Device Name

AllTest Fentanyl Urine Test Cassette

Indications for Use (Describe)

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 K233417

1. Date:	October 26, 2023
2. Submitter:	Hangzhou Alltest Biotech Co., Ltd.#550, Yinhai StreetHangzhou, Zhejiang, China 310018
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite HGaithersburg, MD 20877Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com

AllTest Fentanyl Urine Test Cassette 4. Device Name:

Classification:	Class II
Product Code	CFR #		Panel
NGL	21 CFR, 862.3650	Opiate Test System	Toxicology

1. Predicate Devices: K231698 AllTest Fentanyl Rapid Test (Urine)
1. Intended Use:

AllTest Fentanyl Urine Test Cassette is 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 is the preferred confirmatory method. For in vitro diagnostic use only.

1. Device Description:
  AllTest Fentanyl Urine Test Cassette is an immunoassay intended for the qualitative detection of fentanyl in human urine. Each AllTest Fentanyl Urine Test Cassette consists of a Test Cassette and a package insert. Each Test Cassette is sealed with sachets of desiccant in an aluminum pouch.
1. Substantial Equivalence Information

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Item	Device	Predicate – K231698
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
Type of Test	Qualitative	Same
Specimen Type	Human Urine	Same
Intended Use	Over-The-Counter Use	For prescription use
Configurations	Cassette	Same
Storage	4-30°C	Same

9. Test Principle

AllTest Fentanyl Urine Test Cassette 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 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 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.

10. Performance Characteristics

1. Analytical Performance Clearance of candidate device is for addition of OTC claim. See analytical performance in predicate K231698.

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1. Comparison Studies See studies in predicate K231698
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 21 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	0.27	0	20	100
-50% Cutoff	20	0.52	0	20	100
-25% Cutoff	20	0.74	1	19	95
+25% Cutoff	20	1.17	20	0	100
+50% Cutoff	20	1.48	20	0	100
+75% Cutoff	20	1.72	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.

1. Clinical Studies
  Not applicable.
1. Conclusion
  Based on the test principle and performance characteristics of the device, it's concluded that AllTest Fentanyl Urine Test Cassette is 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).