Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, and Wondfo One Step Propoxyphene Urine Test Strip are intended for the qualitative determination of Buprenorphine, Oxycodone, d-Propoxyphene at the specific cut-off concentration in human urine. They are intended for healthcare professionals in a central laboratory setting only and that it is not for use in point-of-care settings.

Device Description

Immunochromatographic assay for drugs of abuse using a lateral flow, one step system for the qualitative detection of specific drugs in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.

AI/ML Overview

This document describes the validation study for the Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, and Wondfo One Step Propoxyphene Urine Test Strip.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the need to demonstrate substantial equivalence to predicate devices, which generally involves showing high agreement rates with a gold standard method. Specific numerical acceptance criteria are not explicitly stated in the provided document. However, the reported performance metrics (percentage agreement and 95% Confidence Intervals) indicate the device's accuracy. We will present the lowest reported agreement rates across all viewers for each drug as representative performance.

Drug	Acceptance Criteria (Implied)	Reported Device Performance (Lowest %) (95% CI)
Buprenorphine	High agreement with GC-MS for positives and negatives.	Positive Agreement: 90% (74.5% - 100%)Negative Agreement: 95% (79.5% - 100%)
Oxycodone	High agreement with GC-MS for positives and negatives.	Positive Agreement: 90% (74.5% - 100%)Negative Agreement: 95% (79.5% - 100%)
Propoxyphene	High agreement with GC-MS for positives and negatives.	Positive Agreement: 87.5% (72.0% - 100%)Negative Agreement: 95% (79.5% - 100%)

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

Test Set Sample Size:
- For each drug (Buprenorphine, Oxycodone, Propoxyphene): 80 clinical urine specimens (40 negative and 40 positive).
- Total test samples across all three drugs: 240 specimens (80 for each drug).
Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Guangzhou Wondfo Biotech Co., Ltd. in Guangzhou, P.R. China, and samples were partly from "Shenzhen Drug Addiction Recovery Center," suggesting data originated from China.
- Retrospective or Prospective: Retrospective. The samples were "clinical urine specimens" and existing "drug clinical samples" were used.

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

Number of Experts for Ground Truth: Not applicable in the traditional sense of human experts interpreting images or complex data. The ground truth was established by Gas Chromatography-Mass Spectrometry (GC-MS) analysis, which is a highly accurate analytical method, not human interpretation.
Qualifications of Experts (for device reading): The Wondfo tests were read by "three viewers." No specific qualifications for these viewers are provided (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document states, "Each Wondfo test was read by three viewers." However, it presents separate agreement rates for each "Viewer A," "Viewer B," and "Viewer C." This indicates that there was no explicit adjudication method mentioned to combine or reconcile differences between the three viewers' readings to establish a single device result per sample. Each viewer's interpretation was compared independently against the GC-MS ground truth.

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 MRMC comparative effectiveness study was done in the context of human readers improving with AI assistance. This study evaluates the standalone performance of the test strips, which are non-AI diagnostic devices. The "readers" are interpreting the strip results, not using AI.

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

Yes, a standalone study was done. The Wondfo One Step Urine Test Strips are lateral flow immunochromatographic assays. Their "performance" is inherently standalone, as they produce a visual result (a line or lack thereof) without an AI algorithm or human intervention to process the result beyond visual interpretation. The reported agreement percentages are for the interpretation of the test strip's result against the GC-MS ground truth.

7. The type of ground truth used

The ground truth used was Gas Chromatography-Mass Spectrometry (GC-MS) analysis. This is an analytical chemistry method that provides definitive identification and quantification of substances, making it a highly reliable gold standard for drug detection in urine.

8. The sample size for the training set

Not applicable. This device is an immunochromatographic assay, not an AI/machine learning model. Therefore, there is no "training set" in the context of an algorithm learning from data. The reference to "Originally 25 drug clinical samples of varying concentrations were from Cutoff Value section" and "10 negative samples and additional 45 clinical samples were from Shenzhen Drug Addiction Recovery Center" within the "Sample description" for the test set seems to describe the origin of samples for the performance evaluation, not a separate training phase.

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

Not applicable. As there is no training set for an AI/machine learning algorithm, the concept of establishing ground truth for a training set does not apply. The ground truth for the performance evaluation samples was established by GC-MS.

Summary

{0}------------------------------------------------

Premarket Notification - Guangzhou Wondfo Biotech Co. Ltd.

510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)

K093175 AUG 25 2010

Date the summary was prepared: August 18, 2010
Submitter's name: Address:

Phone: Fax:

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 00-86-20-8711-1274-8999 00-86-20-8711-1434

Name of contact person:

Howard Mann SHERBO ASSOCIATES 1 Congressional Drive, Apt. C, Greenville, DE 19807 Phone: 215-369-3785 Fax: 215-369-5246 Email: sheryl@sherboassociates

Name of the device

Common or usual name:

Immunochromatographic test for the qualitative detection of: Buprenorphine Oxycodone Propoxyphene

Trade or Proprietary or model name:

Trade or Proprietary or model name	Model Number
1. Wondfo One Step Buprenorphine Urine Test Strip	W13-S
2. Wondfo One Step Oxycodone Urine Test Strip	W21-S
3. Wondfo One Step Propoxyphene Urine Test Strip	W57-S

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

Product Code	CFR #
DJG	21CFR 862.3650
DJG	21CFR 862.3650
JXN	21CFR 862.3700

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Acon Laboratories, Inc. Acon BUP One Step Buprenorphene Test Strip, K060466.
Acon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip, K033047
Acon Laboratories, Inc. Acon PPX One Step Propoxyphene Test Strip, K040445

{1}------------------------------------------------

5. Description of the device:

Assay Principle: Immunochromatographic assay for drugs of abuse using a lateral flow, one step system for the qualitative detection of specific drugs in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.

6. Intended use of the device:

7. Comparison to the predicate device

A summary comparison of the features of the Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, Wondfo One Step Propoxyphene Urine Test Strip and the predicate devices Is provided in the Table 1.

Similarities
Item	Device	Predicate
Intended Use	Same	For the qualitative determination of buprenorphine,oxycodone, propoxyphene individual in human urine.
Calibrator	Same	Buprenorphine (buprenorphine)Oxycodone (oxycodone)Propoxyphene (propoxyphene)
Methodology	Same	Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibody immunochemistry.
Type Of Test	Same	Immunoassay principles that rely on antigen-antibodyinteractions to indicate positive or negative result
Specimen Type	Same	Human urine
Cut Off Values	Same	Buprenorphine (buprenorphine):10ng/mlOxycodone (oxycodone): 100 ng/mlPropoxyphene (propoxyphene): 300 ng/ml
Configurations	Strip	Strip, Device

Table 1: Features comparison of Wondfo assays and the predicate devices

8. Performance data

8.1 Accuracy

240 (eighty of each drug) clinical urine specimens were analyzed by GC-MS and by each corresponding Wondfo one step drug of abuse test. Each Wondfo test was read by three viewers. Samples were divided by concentration into four categories: less than half the cutoff, near cutoff negative, near cutoff

{2}------------------------------------------------

positive, and high positive.

Sample description: Unaltered clinical urine samples were evaluated. The testing samples include a total of 80 samples (40 negative and 40 positive) for each drug. Originally 25 drug clinical samples of varying concentrations were from Cutoff Value section, 10 negative samples and additional 45 clinical samples were from Shenzhen Drug Addiction Recovery Center. All these samples concentration were confirmed by GC-MS. The concentrations of drug urine samples range from < - 50% cutoff-cutoff, Cutoff-+50%cutoff, >+50%cutoff.

Number of study sites: one Type of study site: Our internal facility Operator description: Our internal staff

The following results are tabulated from comparison studies:

Buprenorphine Method Comparison Study Results

Viewer A:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	1	16	20
Negative	10	10	19	4	0

% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)

% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)

Viewer B:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	2	16	20
Negative	10	10	18	4	0

% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)

% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)

Viewer C:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	0	16	20
Negative	10	10	20	4	0

{3}------------------------------------------------

% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%) % agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)

Viewer A: Wondfo Negative Less than half Near Cutoff Near Cutoff High Positive Result the cutoff Negative Positive (greater than (Between the 50% above the concentration (Between 50% by GC/MS below the cutoff cutoff and 50% cutoff above the cutoff concentration) analysis and the cutoff concentration) concentration) 0 15 23 Positive 0 1

Oxycodone Method Comparison Study Results

10 % agreement among positives is 95% (95% Confidence Interval 79.5% - 100%)

% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)

Viewer B:

Negative

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	2	14	23
Negative	10	10	18	3	0

% agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%)

% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)

Viewer C:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	0	13	23
Negative	10	10	20	4	0

% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)

% agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%

Propoxyphene Method Comparison Study Results

Viewer A

Viewer A.
WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	2	17	19
Negative	10	16	12	4	0

% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)

{4}------------------------------------------------

% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)

Viewer B:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	1	18	19
Negative	10	16	13	3	0

% agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%)

% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)

Viewer C:

WondfoResult	Negative	Less than halfthe cutoffconcentrationby GC/MSanalysis	Near CutoffNegative(Between 50%below the cutoffand the cutoffconcentration)	Near CutoffPositive(Between thecutoff and 50%above the cutoffconcentration)	High Positive(greater than50% above thecutoffconcentration)
Positive	0	0	0	16	19
Negative	10	16	14	5	0

% agreement among positives is 87.5% (95% Confidence Interval 72.0% - 100%)

% agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)

8.2 Performance Characteristics and Other information

The performance characteristics of the Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, and Wondfo One Step Propoxyphene Urine Test Strip were verified by cutoff value, specificity and cross-reactivity, interfering substances, effect of specified gravity of urine pH, precision, stability study. Study results indicate that these test devices are robust and can be stable during the shelf life time when used according to the package inserts.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Guangzhou Wondfo Biotech Co., Ltd. c/o Mr. Howard Mann 1 Congressional Drive, Apt. C Greenville, DE 19807

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

AUG 25 2010

Re: K093175

Trade/Device Name: Wondfo One Step Bruprenorphine Urine Test Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, JXN Dated: August 20, 2010 Received: August 24, 2010

Dear Mr. Mann:

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 class II (Special Controls), 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). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

{6}------------------------------------------------

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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Signature

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

INDICATIONS FOR USE FORM

K093175

510(k) Number (if known): · K093175

Device Name: Wondfo One Step Buprenorphine Urine Test Strip

Indication For Use: The Wondfo One Step Buprenorphine Urine Test Strip is intended for the qualitative determination of buprenorphine in human urine at the cut-off concentration of 10 ng/ml.

The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatographylmass spectrometry (GCMS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.

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 IF NEEDED)

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

Doug Rheinheimer

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

510(k)

Page 1 of 3

{8}------------------------------------------------

K093175

INDICATIONS FOR USE.FORM

510(k) Number (if known): _K093175

Device Name: Wondfo One Step Oxycodone Urine Test Strip

Indication For Use: The Wondfo One Step Oxycodone Urine Test Strip is intended for the qualitative determination of oxycodone in human urine at the cut-off concentration of 100 ng/ml.

The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.

This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.

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 IF NEEDED)

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

Doug Rheinhi

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

Kos3175 510(k)

Page 2 of 3

{9}------------------------------------------------

INDICATIONS FOR USE FORM

K093175

510(k) Number (if known): K093175

Device Name: Wondfo One Step Propoxyphene Urine Test Strip

Indication For Use: The Wondfo One Step Propoxyphene Urine Test Strip is intended for the qualitative determination of propoxyphene in human urine at the cut-off concentration of 300 ng/ml.

The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.

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 IF NEEDED)

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

Dong Rheinheim

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

510(k) . k 09 3175

Page 3 of 3

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).