K Number

Device Name

WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST

Manufacturer

Guangzhou Wondfo Biotech Co., Ltd.

Date Cleared

2012-03-12

(95 days)

Product Code

DJG

Regulation Number

862.3650

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K060466, K033047

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and antibody binding for qualitative detection, with no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No.
The device is an in vitro diagnostic test for the qualitative determination of substances in human urine, not a device used for therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only" for both the Buprenorphine and Oxycodone tests.

SaMD (Software as a Medical Device)

The device description clearly states it is an "immunochromatograph assay" using a "lateral flow, one step system" with physical components like "monoclonal antibody-dye conjugate" and "membrane." This indicates a physical test kit, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section for both the Buprenorphine and Oxycodone tests explicitly states: "For in vitro diagnostic use only."
Nature of the Test: The device performs an "immunochromatographic assay for the qualitative determination of Buprenorphine/Oxycodone in human urine." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (urine) outside of the body to detect the presence of a specific substance (Buprenorphine/Oxycodone).
Purpose: The purpose of the test is to provide preliminary results about the presence of these drugs in a person's system, which is a diagnostic activity.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

DJG

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human urine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Wondfo Buprenorphine Urine Test: prescription use, not intended for point-of-care use.
Wondfo Oxycodone Urine Test: over-the-counter and prescription use.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K060466, K033047

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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:

Intended use of the device:

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 of
Buprenorphine in human urine.	Same
Calibrator	Buprenorphine	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on the
principle of antigen antibody immunochemistry.	Same
Type Of Test	Immunoassay principles that rely on
antigen-antibody interactions to indicate
positive 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)
for
use	For the qualitative determination of
Oxycodone in human urine.	Same
Calibrator	Oxycodone	Same
Methodology	Competitive binding, lateral flow
immunochromatographic assays based on	Same

| | the principle of antigen antibody
immunochemistry. | |
|----------------|-----------------------------------------------------------------------------------------------------------------|------------------|
| Type Of Test | Immunoassay principles that rely on
antigen-antibody interactions to indicate
positive 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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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

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

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

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