Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are intended for the qualitative determination of 11-nor-A9-THC-9-COOH and d-propoxyphene (target analyte) at the specific cut-off concentration in human urine. For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription 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 cup format. This product is only intended for prescription use.

Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/mL. The test is available in a dip card format and a cup format. It is intended for prescription use and over the counter use.

Device Description

Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (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 IqG polyclonal antibody in membrane.

AI/ML Overview

This document describes the Wondfo Cannabinoids Urine Test and the Wondfo Propoxyphene Urine Test, both qualitative immunochromatographic assays for detecting specific drug metabolites in human urine.

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

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative "acceptance criteria" or a "reported device performance" table in the typical sense (e.g., sensitivity, specificity thresholds with corresponding results). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through similar technological characteristics and intended use. The performance is assessed by comparison to the predicate devices.

However, based on the context of drug screening devices and the comparison tables, we can deduce the key performance characteristics that are considered equivalent.

Performance Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Implied by Equivalence)
Cannabinoids Test
Calibrator	11-nor-Δ9-THC-9-COOH	11-nor-Δ9-THC-9-COOH
Methodology	Competitive binding, lateral flow immunochromatographic	Competitive binding, lateral flow immunochromatographic
Specimen Type	Human Urine	Human Urine
Cut Off Values	50 ng/mL	50 ng/mL
Propoxyphene Test
Calibrator	d-propoxyphene	d-propoxyphene
Methodology	Competitive binding, lateral flow immunochromatographic	Competitive binding, lateral flow immunochromatographic
Specimen Type	Human Urine	Human Urine
Cut Off Values	300 ng/mL	300 ng/mL

Note: The FDA's substantial equivalence determination implies that the performance of the Wondfo devices is comparable to that of the predicate devices for their stated indications. Specific quantitative performance data (e.g., precision, accuracy percentages) is not included in this summary but would typically be part of a full 510(k) submission.

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

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the performance study reports submitted as part of the 510(k), but it is not summarized here.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. For drug testing devices, ground truth is typically established using a reference method like Gas Chromatography-Mass Spectrometry (GC/MS).

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. This would typically be relevant for studies involving human interpretation or subjective assessments, which isn't directly applicable to the core function of these immunoassay devices. If a study involved comparing the device's output to a confirmatory method, the "adjudication" would be based on the result of the confirmatory method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it applicable to these devices. These are standalone diagnostic test devices (immunoassays) that produce a qualitative result (positive/negative) based on a chemical reaction, not on human interpretation of complex images or data where "human readers improve with AI vs. without AI assistance" would be relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies supporting these devices are inherently standalone performance studies. The devices themselves are designed to operate without human intervention in result generation; the reading of the test strip/cup is a direct visual interpretation of the chemical reaction. The comparison to predicate devices, and underlying performance studies (though not detailed here), would be based on the device's ability to accurately detect the target analytes.

7. Type of Ground Truth Used

Based on common practices for drug testing devices, the type of ground truth used would almost certainly be a confirmatory analytical method, specifically Gas Chromatography-Mass Spectrometry (GC/MS). Both indications for use statements explicitly mention GC/MS as the preferred confirmatory method for obtaining a confirmed analytical result.

8. Sample Size for the Training Set

The document does not specify the sample size for any training set. These devices are immunoassays that rely on established chemical principles; they typically do not involve machine learning algorithms that require "training sets" in the same way modern AI/ML devices do. Performance data would be collected from clinical samples to validate the device.

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

As these devices do not utilize a "training set" in the context of machine learning, this question is not applicable. The underlying validation of the immunoassay chemistry would be established through analytical studies using controlled samples with known concentrations of the target analytes, and then validated with clinical samples where truth is established by a confirmatory method like GC/MS.

Summary

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K121557

1. Date the summary was prepared:	July 18, 2012	JUL 2 5 2012
2. Submitter's name:	Guangzhou Wondfo Biotech Co., Ltd.
Address:	South China University of Technology
	Guangzhou, P.R. China 510641
Phone:	012-86-20-32296069
Name of contact person:	Joe Shia
	LSI International Inc.
	504 East Diamond Ave.,
	Suite F Gaithersburg, MD 20878
	Telephone: 240-505-7880
	Fax: 301-916-6213
3. Name of the device	Wondfo Cannabinoids Urine Test
	Wondfo Propoxyphene Urine Test
Common or usual name:	Cannabinoids Urine Test
	Propoxyphene Urine Test
Trade or proprietary name:	Wondfo Cannabinoids Urine Test
	Wondfo Propoxyphene Urine Test

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

Product Code	CFR #
LDJ	21 CFR 862.3870
JXN	21 CFR 862.3700

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
Acon Laboratories, Inc. ACON One Step Drug Screen Test, K020771.
Acon Laboratories, Inc. ACON One Step Propoxyphene Test Device and Test Strip, K040445
Description of the device:

TABLE 4

Assay Principle: Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (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 IqG polyclonal antibody in membrane.

Intended use of the device:

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Comparison to the predicate device

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

Table 1: Features Comparison of the Wondfo Cannabinoids Urine Test and the Predicate Device

Item	Device	Predicate - K020771
Indication(s) forUse	For the qualitative determination ofCannabinoids in human urine.	Same
Calibrator	11-nor-Δ9-THC-9-COOH	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	50 ng/mL	Same
Configurations	Cup, Dip Card	Card, Card withIntegrated Cup
Intended Use	OTC Use & Prescription Use	Prescription Use

Table 2: Features Comparison of the Wondfo Propoxyphene Urine Test and the Predicate Device

ltem	Device	Predicate - K040445
Indication(s) forUse	For the qualitative determination ofd-Propoxyphene in human urine.	Same
Calibrator	d-propoxyphene	Same
Methodology	Competitive binding, lateral flowimmunochromatographic assays based onthe principle of antigen antibodyimmunochemistry.	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	300 ng/ml	Same
Configurations	Cup, Dip Card	Strip, device
Intended Use	Prescription Use	Same

The Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test have similar technological characteristics and performance to the predicates. They are equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the text "Food and Drug Administration". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Food and Drug" on the first line and "Administration" on the second line.

10903 New Hampshire Avenue Silver Spring, MD 20993

Guangzhou Wondfo Biotech Co., Ltd c/o Joe Shia c/o LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877

JUL 25 2012

K121557 Re:

Trade Name: Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ, JXN Dated: June 26, 2012 Received: July 16, 2012

Dear Mr Shia:

We have reviewed your Section 510(k) premarket notification of intent to market the device we forenced 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 interstate conments, or to devices that have been reclassified in accordance with the provisions of Amentalions, or to act roos man man metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Mry, it may be such as Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device can be loand in Title Bey 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 modified in any Federal statutes and regulations administered by other Federal agencies. of the riot of arry I outer that Act's requirements, including, but not limited to: registration 1 ou intest comps " 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 Four thay 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,

V. K. Jain, Ph.D.

Courtney 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): K121557

Device Name: Wondfo Propoxyphene 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 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 _____________________________________________________________________________________________________________________________________________________________ × (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)

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

510(k) K121557

Page 1 of_ 일

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Indications for Use Form

510(k) Number (if known): K121557

Device Name: Wondfo Cannabinoids Urine Test

Indications for Use:

The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a conformed 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.

Prescription Use X (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) K121337

Page 2 of 2

Regulation Number and Section

§ 862.3870 Cannabinoid test system.

(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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).