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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Wondfo Buprenorphine Urine Test, based on the provided text:

Acceptance Criteria and Device Performance

The provided text only explicitly states the performance for the lay-user study as percentages of agreement with GC/MS. This can be interpreted as the acceptance criteria for user comprehension and accurate result interpretation by lay users.

Concentration Level (relative to 10 ng/mL cutoff)	Acceptance Criteria (Agreement with GC/MS)	Reported Device Performance (Cup Format)	Reported Device Performance (Dip Card Format)
Negative	100%	100%	100% (referred to as -100% Cutoff)
-75% Cutoff	High agreement expected, generally >95% for negative interpretation	100%	100%
-50% Cutoff	High agreement expected, generally >95% for negative interpretation	100%	100%
-25% Cutoff	High agreement expected, generally >95% for negative interpretation	90.0%	90.0%
+25% Cutoff	High agreement expected, generally >95% for positive interpretation	95.0%	100%
+50% Cutoff	100%	100%	100%
+75% Cutoff	100%	100%	100%

Note: The acceptance criteria are inferred based on the observed high agreement for most concentrations. The 90.0% and 95.0% performance at +/-25% cutoff suggests a tolerance for slight variations near the cutoff, which is common in qualitative assays.

Study Information

2. Sample Size and Data Provenance:

Test Set Sample Size (Lay-user study):
- Cup format: 140 lay persons were involved. The urine samples were prepared at 7 different concentrations, with 20 samples per concentration. So, a total of 140 urine samples were tested.
- Dip Card format: 140 lay persons were involved. The urine samples were prepared at 7 different concentrations, with 20 samples per concentration. So, a total of 140 urine samples were tested.
Data Provenance: The study was performed at "three intended user sites." The country of origin is not explicitly stated, but the manufacturer is "Guangzhou Wondfo Biotech Co., Ltd." in Guangzhou, P.R. China. The study appears to be a prospective user study, as participants were provided with blind-labeled samples and devices for testing.

3. Number of Experts and Qualifications for Ground Truth:

Number of Experts: Not applicable. The ground truth for the test set was established by objective chemical analysis (GC/MS), not by expert interpretation of the device results.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. The ground truth was established by GC/MS, which is a definitive chemical method and does not require adjudication of human interpretations. The lay users performed the test and recorded the results, which were then compared to the GC/MS confirmed concentrations.

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

MRMC Study Done: No, an MRMC comparative effectiveness study was not done. This study focuses on the agreement of lay users with the device results compared to a gold standard (GC/MS), not on comparing human reader performance with and without AI assistance.

6. Standalone Performance Study:

Standalone Study Done: Yes, in essence, the "Lay-user study" is a standalone performance study in the context of Over-the-Counter (OTC) use. It evaluates the device's ability to provide accurate results when used by its intended end-users (lay persons) without professional intervention. The device's output (positive/negative) is directly compared to the true concentration.
- The document also references "Analytical Performance" and "Comparison Studies" in predicate K113624, implying that a more technical standalone analytical performance (measuring sensitivity, specificity, accuracy against known concentrations) would have been performed and documented in the predicate device’s submission.

7. Type of Ground Truth Used:

Ground Truth Type: Objective chemical analysis, specifically GC/MS. The concentrations of urine samples were "confirmed by GC/MS."

8. Sample Size for the Training Set:

Training Set Sample Size: The document does not provide information about a "training set" or explicit details of the algorithm's development. This is a point-of-care immunoassay, not an AI device in the modern sense. Therefore, the concept of a training set for an algorithm is not directly applicable here. The device's performance relies on its physical and chemical properties developed through traditional R&D, not machine learning.

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

Ground Truth Establishment for Training Set: Not applicable, as there isn't a "training set" in the context of an algorithm. The development of such immunoassay devices typically involves extensive analytical testing of various concentrations and interfering substances to optimize the performance characteristics (e.g., antibody specificity, cutoff concentration calibration), which would form the "ground truth" for its design and manufacturing.

Summary

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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.

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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.

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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:

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. The results are summarized below.

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:

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. The results are summarized below.

Concentration	Number ofsamples	OTC user		%AgreementWith GC/MS
		Positive	Negative
-100% Cutoff	20	0	20	100

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-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.

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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.

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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

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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)

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).