(46 days)
Wondfo Methylenedioxymethamine Urine Test is an immunochromatographic assay for the qualitative determination of MDMA in human urine at a cutoff concentration of 500ng/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.
Wondfo Morphine Urine Test is an Immunochromatographic assay for the qualitative determination of Morphine in human urine at a cutoff concentration of 300ng/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.
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.
Immunochromatograph assay for Methylenedioxymethamphetamine and Morphine Urine Test using a lateral flow, one step system for the qualitative detection of MDMA, Morphine (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.
The provided document describes the Wondfo Methylenedioxymethamphetamine Urine Test and Wondfo Morphine Urine Test for the qualitative determination of MDMA and Morphine in human urine. However, the document does not contain specific acceptance criteria or performance study data with numerical results that would allow for a table comparing acceptance criteria to reported device performance. It primarily focuses on the device description, intended use, and substantial equivalence to predicate devices, along with the FDA's clearance letter.
Therefore, many of the requested details about acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted from this document.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is missing:
1. A table of acceptance criteria and the reported device performance
The provided document does not specify quantitative acceptance criteria for performance such as sensitivity, specificity, or accuracy, nor does it present detailed performance study results against such criteria. It states that the device has "similar technological characteristics and performance to the predicate and are equivalent."
The key performance characteristics mentioned are the cut-off values:
| Analyte | Cut-off Value |
|---|---|
| Methylenedioxymethamphetamine | 500 ng/ml |
| Morphine | 300 ng/ml |
The document does not include a study that provides reported device performance values (e.g., sensitivity, specificity, accuracy) against these cut-off levels or any other defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For drug tests, ground truth is typically established by confirmatory methods like GC/MS, not expert consensus in the same way as imaging analysis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This type of study is not applicable to this device. The Wondfo Urine Tests are qualitative immunoassay devices for drug detection, not AI/imaging analysis tools that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone test kit (lateral flow immunoassay). The document implies its performance was evaluated standalone by stating its "technological characteristics and performance to the predicate and are equivalent," but it does not detail the specific standalone study methodology or results. There is no "algorithm" in the sense of software for interpretation for this type of device; the user directly interprets the lines on the test card.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document explicitly states: "A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS is the preferred confirmatory method." Therefore, the ground truth for establishing device performance would have been Gas Chromatography/Mass Spectrometry (GC/MS).
8. The sample size for the training set
This information is not provided in the document. As an immunoassay, the concept of a "training set" in the machine learning sense is not directly applicable. However, if this refers to samples used for initial development or optimization, those details are not present.
9. How the ground truth for the training set was established
This information is not provided for a "training set." If development or optimization samples were used, the ground truth would likely have been established using a confirmatory method like GC/MS, similar to the test set, but specific details are absent.
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Premarket Notification - Guangzhou Wondfo Biotec
| TABLE 4 | SUMMARY | |
|---|---|---|
| 1. Date the summary was prepared: | June 15, 2011 | SEP 19 2011 |
| 2. Submitter's name:Address: | Guangzhou Wondfo Biotech Co., Ltd.South China University of TechnologyGuangzhou, P.R. China 510641 | |
| Phone: | 012-86-20-32296069 | |
| Name of contact person: | Joe ShiaLSI 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: | Methylenedioxymethamphetamine Urine TestMorphine Urine Test |
|---|---|
| Trade or proprietary name: | Wondfo Methylenedioxymethamphetamine Urine TestWondfo Morphine Urine test |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| LFG | 21CFR 862.3610 |
| DJG | 21CFR862.3650 |
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
1). Acon Laboratories, Inc., ACON® One Step Drug Screen Test, K020771.
- 2). Acon Laboratories, Inc., Acon® MDMA One Step Ecstasy Test, K022589
- Description of the device:
Assay Principle: Immunochromatograph assay for Methylenedioxymethamphetamine and Morphine Urine Test using a lateral flow, one step system for the qualitative detection of MDMA, Morphine (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.
- Intended use of the device:
Wondfo Methylenedioxymethamphetamine Urine Test and Wondfo Morphine Urine are intended for the qualitative determination of MDMA, Morphine (target analyte) at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
- Comparison to the predicate device
A summary comparison of the features of the Wondfo Methylenedioxymethamphetamine Urine Test and Wondfo Morphine Urine test and the predicate devices is provided in the Table 1.
| Item | Device | Predicate |
|---|---|---|
| Indication(s) foruse | For the qualitative determination ofMethylenedioxymethamphetamine, Morphineindividual in human urine. | Same (but the numberof drugs detecteddifferent) |
Table 1: Features comparison of Wondfo assays and the predicate devices
LSI International Inc.
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| Methodology | Competitive binding, lateral flow,immunochromatographic assays based on theprinciple of antigen antibodyimmunochemistry. | Same |
|---|---|---|
| Type Of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive ornegative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Methylenedioxymethamphetamine:500 ng/mlMorphine: 300ng/ml | Same (but the numberof drugs detecteddifferent) |
| Configurations | Cup, dip card | Card, dip card with anintegrated cup (same)Strip, device for MDMA |
| Intended Use | OTC Use & Prescription Use | Prescription Use |
The Wondfo Methylenedioxymethamphetamine Urine Test and Wondfo Morphine Urine test have similar technological characteristics and performance to the predicate and are equivalent.
:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo with a circle of text surrounding a stylized bird. The text is small and difficult to read, but it appears to be the name of an organization. The bird is depicted with three curved lines, suggesting movement or flight. The logo is simple and clean, with a focus on the bird as a symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia Regulatory Consultant LSI International Inc. 12828 Doe Lane Gaithersburg, MD 20878
SEP 1 9 201
Re: K112236 Trade Name: Wondfo Methylenedioxymethamphetamine Urine Test Wondfo Morphine Urine Test Regulation Number: 21 CFR 862. 3610 Regulation Name: Methamphetamine test system Regulatory Class: Class II Product Codes: LAF, DJG Dated: August 1, 2011 Received: August 4, 2011
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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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 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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/def.ault.htm.
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology 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):
Device Name: 'Wondfo Methylenedloxymethamphetamine Urine Test
Indications for Use:
Wondfo Methylenedioxymethamine Urine Test is an immunochromatographic assay for the qualitative determination of MDMA in human urine at a cutoff concentration of 500ng/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.
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 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)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K112236
Page 1 of 2
LSI International Inc.
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Indications for Use Form
510(k) Number (if known):
Device Name: Wondfo Morphine Urine Test
Indications for Use:
Wondfo Morphine Urine Test is an Immunochromatographic assay for the qualitative determination of Morphine in human urine at a cutoff concentration of 300ng/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.
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_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)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K112236
Page 2 of 2
LS! International Inc.
§ 862.3610 Methamphetamine test system.
(a)
Identification. A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.(b)
Classification. Class II (special controls). A methamphetamine 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).