(46 days)
Not Found
No
The device description and intended use describe a standard immunochromatographic assay (lateral flow test) for drug detection in urine. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML. The performance studies and training/test set descriptions are also not present, which would typically be included for an AI/ML device.
No
This device is an in vitro diagnostic test for the qualitative determination of MDMA and Morphine in human urine. It is used to detect the presence of these substances and does not provide therapy or treatment.
Yes
Explanation: The device is an "immunochromatographic assay for the qualitative determination of MDMA/Morphine in human urine," which provides preliminary test results to determine the presence of substances in the body, fitting the definition of a diagnostic device.
No
The device description clearly states it is an immunochromatographic assay available in dip card and cup formats, which are physical hardware components.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the "qualitative determination of MDMA and Morphine in human urine." This involves testing a sample taken from the human body (urine) outside of the body to provide information about a person's health status (presence of drugs). This aligns directly with the definition of an in vitro diagnostic device.
- Device Description: The description details an "Immunochromatograph assay" that uses antibodies to detect specific substances (MDMA and Morphine) in a biological sample (human urine). This is a common method used in IVD tests.
- Anatomical Site: The test is performed on "human urine," which is a biological specimen.
- Predicate Devices: The listed predicate devices (ACON® One Step Drug Screen Test and Acon® MDMA One Step Ecstasy Test) are also IVD devices used for drug screening in urine. This further supports the classification of this device as an IVD.
The fact that it is intended for both prescription and over-the-counter use, and provides preliminary results requiring confirmation, are all characteristics commonly associated with IVD devices.
N/A
Intended Use / Indications for Use
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.
For the Wondfo Methylenedioxymethamphetamine Urine Test:
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.
For the Wondfo Morphine Urine Test:
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.
Product codes (comma separated list FDA assigned to the subject device)
LFG, DJG
Device Description
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.
Methodology: Competitive binding, lateral flow, immunochromatographic assays based on the principle of antigen antibody immunochemistry.
Type Of Test: Immunoassay principles that rely on antigen-antibody interactions to indicate positive or negative result
Results: Qualitative
Specimen Type: Human urine
Cut Off Values: Methylenedioxymethamphetamine: 500 ng/ml Morphine: 300ng/ml
Configurations: Cup, dip card
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
healthcare professional use and over the counter 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): 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.
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
§ 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).
0
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 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: 301-916-6231
- Name of the device
| Common or usual name: | Methylenedioxymethamphetamine Urine Test
Morphine Urine Test |
|----------------------------|-------------------------------------------------------------------------------|
| Trade or proprietary name: | Wondfo Methylenedioxymethamphetamine Urine Test
Wondfo 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) for | ||
| use | For the qualitative determination of | |
| Methylenedioxymethamphetamine, Morphine | ||
| individual in human urine. | Same (but the number | |
| of drugs detected | ||
| different) |
Table 1: Features comparison of Wondfo assays and the predicate devices
LSI International Inc.
1
| 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 | Methylenedioxymethamphetamine:500 ng/ml
Morphine: 300ng/ml | Same (but the number
of drugs detected
different) |
| Configurations | Cup, dip card | Card, dip card with an
integrated 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.
:
2
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).
3
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
4
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.
5
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.