K Number

Device Name

ACON BUP ONE STEP BUPRENORPHINE TEST STRIP

Manufacturer

Guangzhou Wondfo Biotech Co., Ltd.

Date Cleared

2013-02-14

(36 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. It is intended for over the counter use. The Buprenorphine assay will yield preliminary positive results when Buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The Wondfo Buprenorphine Urine Test shows the drug was or was not present at the cutoff level. 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. The device does not differentiate between drug abuse and prescription use of buprenorphine.

Device Description

Immunochromatograph assays for Buprenorphine Urine Tests use a lateral flow, one step system for the qualitative detection of Buprenorphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

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

K113624

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies indicate a standard immunochromatographic assay, with no mention of AI or ML components.

Therapeutic

Explanation: The device is a diagnostic tool for detecting Buprenorphine in urine, not a device used to provide therapy or treatment.

Diagnostic

Yes

Explanation: The device is an "immunochromatographic assay for the qualitative determination of Buprenorphine in human urine," which is a test used to identify the presence of a specific substance (buprenorphine) in a biological sample (urine). This is a diagnostic function, even though it provides "preliminary test results" that require confirmation.

SaMD (Software as a Medical Device)

The device description clearly states it is an immunochromatographic assay available in dip card and cup formats, which are physical hardware components.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is an "immunochromatographic assay for the qualitative determination of Buprenorphine in human urine". This clearly indicates that the device is intended to be used in vitro (outside the body) to examine a specimen (human urine) to provide information about a physiological state (presence of Buprenorphine).
Device Description: The description details the components and mechanism of the assay, which is a common format for describing IVD devices.
Performance Studies: The description of performance studies involving testing human urine samples further supports its classification as an IVD.

The fact that it is intended for "over the counter use" and provides "preliminary test results" does not negate its classification as an IVD. Many IVDs are designed for home use and provide initial screening results.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Buprenorphine assay will yield preliminary positive results when Buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The Wondfo Buprenorphine Urine Test shows the drug was or was not present at the cutoff level. 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.

The device does not differentiate between drug abuse and prescription use of buprenorphine.

Product codes (comma separated list FDA assigned to the subject device)

DJG

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

OTC 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

A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 68 females and 72 males tested the Buprenorphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with a package insert, 1 blind labeled sample and a device.

A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 71 females and 69 males tested the Buprenorphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations: negative, +/-75%, +/-25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. Each sample was aliquoted into individual containers and blind-labeled. Each participant was provided with a package insert, 1 blind labeled sample and a device.

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

Clearance of candidate device is for addition of OTC claim. See analytical performance in predicate K113624.

Lay-user study:
Test Cup format: A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 68 females and 72 males tested the Buprenorphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations; negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. The results are summarized below.

Concentration	Number of samples	OTC user (Positive)	OTC user (Negative)	% Agreement With GC/MS
Negative	20	0	20	100
-75% Cutoff	20	0	20	100
-50% Cutoff	20	0	20	100
-25% Cutoff	20	2	18	90.0
+25% Cutoff	20	19	1	95.0
+50% Cutoff	20	20	0	100
+75% Cutoff	20	20	0	100

Dip Card format: A lay user study was performed at three intended user sites with 140 lay persons. Participants in the study were 71 females and 69 males tested the Buprenorphine samples. They had diverse educational and professional backgrounds and ranged in age from 21 to >50. Urine samples were prepared at the following concentrations: negative, +/-75%, +/-25% of the cutoff by spiking drug into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS. The results are summarized below.

Concentration	Number of samples	OTC user (Positive)	OTC user (Negative)	% Agreement With GC/MS
-100% Cutoff	20	0	20	100
-75% Cutoff	20	0	20	100
-50% Cutoff	20	0	20	100
-25% Cutoff	20	2	18	90.0
+25% Cutoff	20	20	0	100
+50% Cutoff	20	20	0	100
+75% Cutoff	20	20	0	100

Comparison Studies: See studies in predicate K113624.
Clinical Studies: Not applicable

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

See tables in "Summary of Performance Studies" for %Agreement With GC/MS, which can be interpreted as accuracy.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K113624

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

14 1 300 27

510(k) SUMMARY

FEB 1 4 2013

l. Date:

February 1, 2013

Submitter:
Contact person:

Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641

Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl(@yahoo.com

1. Device Name:
  Wondfo Buprenorphine Urine Test

Classification:

Class II

K113624

Product Code	Regulation Name	CFR #
DJG	Opiate Test System 21CFR 862.3650

Predicate Devices: ડ.

Guangzhou Wondfo Biotech Wondfo Buprenorphine Test

1. 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. It is intended for over the counter use.

The device does not differentiate between drug abuse and prescription use of buprenorphine.

1. Device Description
  Immunochromatograph assays for Buprenorphine Urine Tests use a lateral flow, one step system for the qualitative detection of Buprenorphine (target analyte) in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.
Substantial Equivalence Information 8.

Item	Device	Predicate
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
Results	Qualitative	Same
Specimen Type	Human urine	Same
Cut Off Values	10ng/ml	Same
Configurations	Cup, dip card	Same
Intended Use	OTC Use	Prescription Use

1. Standard/Guidance Document Reference
- Baselt, R.C. Disposition of Toxic Drugs and Chemicals in Man. Biomedical . Publications, Davis, CA, 1982.
- Ellenhorn, M.J. and Barceloux, D. G Medical Toxicology. Elservier Science Publishing . Company, Inc., New York, 1988
- Gilman, A. G., and Goodman, L. S. The Pharmacological Fluids, in Martin WR(ed): . Drug Addiction I, New York, Spring - Verlag, 1977.
- . Hawwks RL, CN Chiang. Urine Testing for drugs of Abuse. National Institute for Drug Abuse (NIDA), Research Monography 73, 1986
- Hofmann F.E., A Handbook on Drug and Alcohol Abuse: The Biomedical Aspects, . New York, Oxford University Press, 1983.

10. Test Principle

It is a rapid test for the qualitative detection of Buprenorphine in urine samples. It is a lateral flow chromatographic immunoassay. When the absorbent end 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 concentration 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 cutoff, 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.

11. Performance Characteristics

1. Analytical Performance
  Clearance of candidate device is for addition of OTC claim. See analytical performance in predicate K113624.
1. Comparison Studies
  See studies in predicate K113624

Lay-user study

Test Cup format:

Concentration	Number of samples	OTC user		%Agreement With GC/MS
Negative	20	0	20	100
-75% Cutoff	20	0	20	100
-50% Cutoff	20	0	20	100
-25% Cutoff	20	2	18	90.0
+25% Cutoff	20	19	1	95.0
+50% Cutoff	20	20	0	100
+75% Cutoff	20	20	0	100

Dip Card format:

| Concentration | Number of
samples | OTC user | | %Agreement
With GC/MS |
|---------------|----------------------|----------|----------|--------------------------|
| | | Positive | Negative | |
| -100% Cutoff | 20 | 0 | 20 | 100 |

-75% Cutoff	20	0	20	100
-50% Cutoff	20	0	20	100
-25% Cutoff	20	2	18	90.0
+25% Cutoff	20	20	0	100
+50% Cutoff	20	20	0	100
+75% Cutoff	20	20	0	100

Clinical Studies

Not applicable

Conclusion

Based on the test principle and performance characteristics of the device, it's concluded that Wondfo Buprenorphine Urine Tests are substantially equivalent to the predicate.

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K130055

Trade/Device Name: Wondfo Buprenorphine Urine Test Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG Dated: January 09, 2013 Received: January 11, 2013

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. Ilsting 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.

February 14, 2013

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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Page 2-Mr. Shia

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.

Carol C. Benson for

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

Indications for Use

510(k) Number (K130055):

Device Name: Wondfo Buprenorphine Urine Test

Indications for Use:

The Buprenorphine assay will vield preliminary positive results when Buprenorphine is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for buprenorphine in urine. The Wondfo Buprenorphine Urine Test shows the drug was or was not present at the cutoff level. 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.

The device does not differentiate between drug abuse and prescription use of buprenorphine.

Prescription Use (21 CFR Part 801 Subpart D)

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

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

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Denise Johnson-lyles -S

2013.02.13 08:54:16 -05'00'

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K130055 510(k)