Wondfo Buprenorphine Urine Test is an immunochromatographic assay for the qualitative determination of Buprenorphine in human urine at a cutoff concentration of 10 ng/mL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. This product is only intended for prescription use and is not intended for point-of-care use.

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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Wondfo Oxycodone Urine Test is an immunochromatographic assay for the qualitative determination of Oxycodone in human urine at a cutoff concentration of 100 ng/mL. The test is available in a dip card format and a cup format. For in vitro diagnostic use only. This product is intended for over-the-counter and prescription 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. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

Immunochromatograph assay for Buprenorphine and Oxycodone Urine Test using a lateral flow, one step system for the qualitative detection of Buprenorphine, Oxycodone(target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

AI/ML Overview

The provided document is a 510(k) premarket notification for in vitro diagnostic devices, specifically urine tests for Buprenorphine and Oxycodone. It describes the devices, their intended use, and compares them to predicate devices to establish substantial equivalence. However, this document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or accuracy.

Instead, it relies on establishing "substantial equivalence" to predicate devices, meaning the new device is as safe and effective as a legally marketed device. The information provided heavily focuses on the features and intended use comparison rather than detailed performance study results against predefined acceptance criteria.

Therefore, many of the requested items cannot be extracted from this document, as a performance study with acceptance criteria, ground truth, sample sizes for test and training sets, and expert involvement is not described.

Here's what can be extracted based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not provide a table of acceptance criteria (e.g., minimum sensitivity, specificity) for device performance, nor does it report specific diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) from a clinical study. The "performance" described is in terms of general characteristics and methodology, establishing similarity to predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not specified.
Data provenance: Not specified. The document is a regulatory submission for a device manufactured by "Guangzhou Wondfo Biotech Co., Ltd." in China, but it doesn't specify the origin of any testing data. The "test set" in the context of a diagnostic performance study is not described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as a formal performance study with expert-established ground truth for a test set is not detailed in this document.

4. Adjudication method for the test set:

This information is not provided as a formal performance study with a test set and adjudication is not detailed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. These devices are simple, qualitative immunochromatographic assays for drug detection in urine, run by technicians. They are not AI-powered image analysis tools that would involve "human readers" in the context of an MRMC study.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:

Yes, in essence, the device is designed for standalone performance in that it provides a visual qualitative result (positive/negative line). Its performance is evaluated by how accurately it detects the target analyte at a given cutoff concentration, which is an "algorithm only" type of assessment for these types of tests. However, specific standalone performance metrics (sensitivity, specificity, accuracy) are not detailed within this summary, nor is the study design for such an evaluation. The document states "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." This implies that the device's "standalone" result is considered preliminary and requires further confirmation by a gold standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The document implies that the "ground truth" for confirming results would be GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry), which are highly sensitive and specific analytical chemical methods. This is explicitly stated: "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."

8. The sample size for the training set:

Not applicable / Not provided. These are immunoassay devices, not AI/ML algorithms that typically involve "training sets" in the conventional sense. Any development or optimization would involve laboratory testing, but a distinct "training set" as understood in machine learning is not relevant here.

9. How the ground truth for the training set was established:

Not applicable / Not provided. As mentioned above, the concept of a "training set" with established ground truth is not relevant for this type of device in the way it's typically understood for AI/ML.

Summary

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K113624

TABLE 4

SUMMARY

1. Date the summary was prepared:
1. Submitter's name: Address:

Phone:

Name of contact person:

March 1, 2012

MAR 1 2 2012

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069

Joe Shia

LSI International.Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6231

Name of the device

Common or usual name:

Trade or proprietary name:

Buprenorphine Urine Test Oxycodone Urine Test Wondfo Buprenorphine Urine Test Wondfo Oxycodone Urine Test

Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:

Product Code	CFR #
DJG	21 CFR 862.3650
DJG	21 CFR 862.3650

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

1. Acon Laboratories, Inc. Acon BUP One Step Buprenorphene Test Strip and Acon BUP One Step Buprenorphene Test Device, K060466.
1. Acon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip and Acon OXY One Step Oxycodone Test Device, K033047

Description of the device:

Assay Principle: Immunochromatograph assay for Buprenorphine and Oxycodone Urine Test using a lateral flow, one step system for the qualitative detection of Buprenorphine, Oxycodone(target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.

Intended use of the device:

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format and a cup format. For in vitro diagnostic use only. This product is only intended for prescription use and is not intended for point-of-care use.

Comparison to the predicate device

A summary comparison of the features of the Wondfo Buprenorphine Urine Test and Wondfo Oxycodone Urine Test and the predicate devices is provided in the Table 1 & Table 2.

Table 1: Features comparison of Wondfo Buprenorphine Urine Test and the predicate device

Item	Device	Predicate - K060466
Indication(s) for use	For the qualitative determination ofBuprenorphine in human urine.	Same
Calibrator	Buprenorphine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibody immunochemistry.	Same
Type Of Test	Immunoassay principles that rely onantigen-antibody interactions to indicatepositive or negative result	Same
Specimen Type	Human urine	Same
Cut Off Values	10 ng/ml	Same
Configurations	Cup, dip card	Strip, Device
Intended Use	Prescription Use	Same

Table 2: Features comparison of Wondfo Oxycodone Urine Test and the predicate device

Item	Device	Predicate - K033047
Indication(s)foruse	For the qualitative determination ofOxycodone in human urine.	Same
Calibrator	Oxycodone	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based on	Same

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	the principle of antigen antibodyimmunochemistry.
Type Of Test	Immunoassay principles that rely onantigen-antibody interactions to indicatepositive or negative result	Same
Specimen Type	Human urine	Same
Cut Off Values	100 ng/ml	Same
Configurations	Cup, dip card	Strip, Device
Intended Use	OTC Use & Prescription Use	Prescription Use

. .

The Wondfo Buprenorphine Urine Test and the Wondfo Oxycodone Urine Test have similar technological characteristics and performances to the predicates. The Wondfo test devices and predicates are equivalent.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines, suggesting a profile view of a person's head and shoulders.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

Guangzhou Wondfo Biotech Co., Ltd c/o Mr. Joe Shia 504 East Diamond Ave, Suite F Gaithersburg, MD 20878

MAR 1 2 2012

Re: K113624

Trade Name: Wondfo Buprenorphine Urine Test, Wondfo Oxycodone Urine Test Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Codes: DJG Dated: February 22, 2012 Received: February 27, 2012

Dear Mr. 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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours.

Signature

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use Form

510(k) Number (if known): K113624

Device Name: Wondfo Buprenorphine Urine Test

Indications for Use:

The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or LC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

(Please do Not WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE (F NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K113624

Page 1 of 2

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Indications for Use Form

510(k) Number (if known): K113624

Device Name: Wondfo Oxycodone Urine Test

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K11 3624

Page 2 of

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).