Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter 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. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even at or above therapentic doses. There is no uniformly recognized cutoff concentration for d-Propoxyphene. It is not intended to distinguish between prescription use or abuse of this drug. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

Device Description

The Wondfo Propoxyphene Urine Test uses immunochromatographic assays for d-Propoxyphene. The test is a lateral flow system for the qualitative detection of d-Propoxyphene in human urine. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Wondfo Propoxyphene Urine Test devices, as extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on a "Lay-user study" for establishing performance in the context of an OTC claim addition. The acceptance criteria for this study are implied by the desired percentage of correct results for various d-Propoxyphene concentrations relative to the 300 ng/mL cutoff. While explicit numerical acceptance criteria (e.g., "must achieve X% accuracy") are not stated, the study demonstrates desired performance.

Urine Sample Concentration (% of Cutoff)	d-Propoxyphene Concentration by GC/MS (ng/mL)	Acceptance Criteria (Implied: High % Correct)	Reported Device Performance - Cup Format (% Correct Results by Lay Person)	Reported Device Performance - DipCard Format (% Correct Results by Lay Person)
-100% of Cutoff (0 ng/mL)	0	100% Negative	100%	100%
-75% of Cutoff	75.6	100% Negative	100%	100%
-50% of Cutoff	148.3	100% Negative	100%	100%
-25% of Cutoff	226.7	High % Negative (e.g., >90%)	90.0%	90.0%
+25% of Cutoff	378.2	High % Positive (e.g., >90%)	90.0%	90.0%
+50% of Cutoff	452.4	100% Positive	100%	100%
+75% of Cutoff	523.1	100% Positive	100%	100%

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

Sample Size for Test Set:
- Lay-user study: 280 lay persons in total, with 140 testing the cup format and 140 testing the dip card format. Each lay person tested one blind-labeled sample.
- For each concentration level represented in the table above, there were 20 samples for the cup format and 20 samples for the dip card format.
Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given that the submitter is Guangzhou Wondfo Biotech Co., Ltd. from China, and the study was performed "at three intended user sites," it's likely the samples and study were conducted in China, and it appears to be a prospective study designed for this submission.

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

Number of Experts: Not applicable in the context of expert review for ground truth in this lay-user study.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The "ground truth" was established independently by GC/MS and then compared directly to the lay user's interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No, an MRMC comparative effectiveness study was not explicitly mentioned or performed in the provided text. The study described is a lay-user study comparing the device's output (as interpreted by lay users) against a gold standard (GC/MS).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Standalone Performance: The Wondfo Propoxyphene Urine Test is an immunochromatographic assay, which is a rapid diagnostic test interpreted by a human. Therefore, the concept of a "standalone algorithm" doesn't directly apply in the same way it would for a digital imaging AI device. The lay user study is a test of human-in-the-loop performance, where the human interprets the result of the assay. The results for the cup and dip card formats are reflective of the final human-interpreted output.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for the test samples was established by Gas Chromatography/Mass Spectrometry (GC/MS). The document states: "The concentrations of the samples were confirmed by GC/MS."

8. The Sample Size for the Training Set

Sample Size for Training Set: The document does not describe a distinct "training set" in the context of machine learning. The device is an immunochromatographic assay, not an AI/ML algorithm that requires training data. Its "training" would involve internal development and optimization by the manufacturer using various chemical and biological samples, but this is not detailed in the provided regulatory document.

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

Ground Truth for Training Set: Not applicable as there is no described AI/ML training set. The assay's performance relies on the specific antibodies and reagents designed to detect propoxyphene, and its development would involve internal validation by the manufacturer using known standards and clinical samples, confirmed typically by methods like GC/MS.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 23, 2015

GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE I GAITHERSBURG MD 20877

Re: K152495

Trade/Device Name: Wondfo Propoxyphene Urine Test Cup Wondfo Propoxyphene Urine Test DipCard Regulation Number: 21 CFR 862.3700 Regulation Name: Propoxyphene test system Regulatory Class: II Product Code: JXN Dated: August 26, 2015 Received: September 1, 2015

Dear Mr. 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 (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. 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.

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney H. Lias -S

Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152495

Device Name

Wondfo Propoxyphene Urine Test Cup Wondfo Propoxyphene Urine Test DipCard

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

1. Date:	October 27, 2015
2. Submitter:	Guangzhou Wondfo Biotech Co., Ltd.No.8 Lizhishan Road, Science City, Luogang District, Guangzhou, P.R.China 510663
3. Contact person:	Joe ShiaLSI International Inc.504 East Diamond Ave., Suite IGaithersburg, MD 20878Telephone: 240-505-7880Fax: 301-916-6213Email:shiajl@yahoo.com

Wondfo Propoxyphene Urine Test Cup (DipCard) 4. Device Name:

Classification:	Class II
Product Code	CFR #	Panel
JXN	21 CFR, 862.3700 Propoxyphene Test System	Toxicology

1. Predicate Devices: K121557 Wondfo Propoxyphene Urine Test
1. Intended Use:

Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a test cup format. It is intended for prescription use and over the counter 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 is the preferred confirmatory method. The test will yield preliminary positive results when prescription drug d-Propoxyphene is ingested, even There is no uniformly recognized cutoff concentration for at or above therapeutic doses. It is not intended to distinguish between prescription use or abuse of this drug. d-Propoxyphene. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

1. Device Description:

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Item	Device	Predicate - K121557
Indication(s)for use	For the qualitative determination ofdrugs of abuse in human urine	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assaysbased on the principle of antigenantibody immunochemistry.	Same
Results	Qualitative	Same
SpecimenType	Human urine	Same
Cut Off Values	d-Propoxyphene: 300ng/ml	Same
Configurations	Cup and DipCard	Same
Conditions forUse	Over-the-Counter	Prescription Use

1. Substantial Equivalence Information

9. Test Principle

The Wondfo Propoxyphene Urine Test is a rapid test for the qualitative detection of d-Propoxyphene in urine samples and contains lateral flow chromatographic immunoassays for d-Propoxyphene. Each assay uses a mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies coated on the test membranes. When the absorbent end of the test is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentrations below the target cut-off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cut-off, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result. A band should form in the control region (C) of the device regardless of the presence of drug or metabolite in the sample.

10. Performance Characteristics

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1. Analytical Performance Clearance of candidate device is for addition of OTC claim. See analytical performance in predicate K121557.
1. Comparison Studies See studies in predicate K121557
1. Lay-user study

A lay user study was performed at three intended user sites with 280 lay persons, of which 140 tested for the cup format and another 140 tested dipcard format. 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%, +/-25%, +/-25% of the cut-off by spiking d-Propoxyphene into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/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	d-Propoxyphene Concentration by GC/MS (ng/mL)	Lay person results		The percentage of correct results (%)
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75.6	0	20	100
-50% Cutoff	20	148.3	0	20	100
-25% Cutoff	20	226.7	2	18	90.0
+25% Cutoff	20	378.2	18	2	90.0
+50% Cutoff	20	452.4	20	0	100
+75% Cutoff	20	523.1	20	0	100

Comparison between GC/MS and Lay Person Results for Cup Format

Comparison between GC/MS and Lay Person Results for DipCard Format

	Numberofsamples	d-PropoxypheneConcentration by GC/MS(ng/mL)	Lay person results		Thepercentage ofcorrect results(%)
% of Cutoff			No. ofPositive	No. ofNegative
-100% Cutoff	20	0	0	20	100
-75% Cutoff	20	75.6	0	20	100
-50% Cutoff	20	148.3	0	20	100
-25% Cutoff	20	226.7	2	18	90.0
+25% Cutoff	20	378.2	18	2	90.0
+50% Cutoff	20	452.4	20	0	100
+75% Cutoff	20	523.1	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

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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 Wondfo Propoxyphene Urine Test is substantially equivalent to the predicate.

Regulation Number and Section

§ 862.3700 Propoxyphene test system.

(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene 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).