(65 days)
Not Found
No
The description details a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and antibody binding for detection, not AI/ML. There is no mention of AI, ML, or any computational analysis of results beyond a qualitative determination.
No
This device is a diagnostic test for detecting substances (cocaine and methamphetamine) in urine, not a device used to treat or cure a disease or condition.
Yes
The device is intended for the qualitative determination of specific substances (Benzoylecgonine and D(+)-Methamphetamine) in human urine, which is a method of identifying or evaluating a condition, consistent with a diagnostic device.
No
The device description clearly states it is an "Immunochromatograph assay" using a "lateral flow, one step system" with "monoclonal antibody-dye conjugate" and "fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane." This describes a physical, hardware-based test kit, not a software-only device.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the tests are for the "qualitative determination of Benzoylecgonine, D(+)-Methamphetamine (target analyte) at the specific cut-off concentration in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide diagnostic information (presence or absence of the drug above a certain level).
- Device Description: The description details an "Immunochromatograph assay" which is a common type of in vitro diagnostic test. It describes the components used to analyze the urine sample.
- Target Analyte: The tests are designed to detect specific substances (Benzoylecgonine and D(+)-Methamphetamine) within the urine sample.
- Healthcare Professional and Over-the-Counter Use: While over-the-counter use is mentioned, the core function is still an in vitro diagnostic test. Many IVDs are available for over-the-counter use.
The key characteristics of an IVD are present: testing a sample from the human body outside the body to provide information about a person's health or condition.
N/A
Intended Use / Indications for Use
Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test are intended for the qualitative determination of Benzoylecgonine, D(+)-Methamphetamine (target analyte) at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Product codes (comma separated list FDA assigned to the subject device)
DIO, LAF
Device Description
Immunochromatograph assay for Cocaine and Methamphetamine Urine Test using a lateral flow, one step system for the qualitative detection of Benzoylecgonine, D(+)-Methamphetamine (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
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
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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
KI12071
SUMMARY
| 1. Date the summary was prepared: | June 15, 2011 | SEP 2 3 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 | ||
| 3. Name of the device | ||
| Common or usual name: | Cocaine Urine Test | |
| Methamphetamine Urine Test | ||
| Trade or proprietary name: | Wondfo Cocaine Urine Test | |
| Wondfo Methamphetamine Urine Test |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| DIO | 21CFR 862.3250 |
| LAF | 21CFR 862.3610 |
-
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. One Step Drug Screen Test, K020771.
-
- Description of the device:
TABLE 4
Assay Principle: Immunochromatograph assay for Cocaine and Methamphetamine Urine Test using a lateral flow, one step system for the qualitative detection of Benzoylecgonine, D(+)-Methamphetamine (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 Cocaine Urine Test and Wondfo Methamphetamine Urine Test are intended for the qualitative determination of Benzoylecgonine, D(+)-Methamphetamine (target analyte) at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
- Intended use of the device:
- Comparison to the predicate device
A summary comparison of the features of the Wondfo Cocaine Urine Test, Wondfo Methamphetamine Urine Test and the predicate devices is provided in the Table 1.
| Item | Device | Predicate |
|---|---|---|
| Indication(s) for | ||
| use | For the qualitative determination of | |
| Cocaine, Methamphetamine individual | ||
| in human urine. | Same (but the number | |
| of drugs detected | ||
| different) | ||
| Methodology | Competitive binding, lateral flow | |
| immunochromatographic assays based | Same |
Table 1: Features comparison of Wondfo assays and the predicate devices
LSI International Inc.
1
| | on the principle of antigen antibody
immunochemistry. | |
|----------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| 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 | Cocaine:300 ng/ml
Methamphetamine:1000 ng/ml | Same (but the number
of drugs detected
different) |
| Configurations | Cup, dip card | Card, dip card with an
integrated cup (same) |
| Intended Use | OTC Use & Prescription Use | Prescription Use |
The Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test have similar technological characteristics and performance to the predicate and are equivalent.
2
Image /page/2/Picture/1 description: The image shows a logo with a stylized bird in flight on the right side. The bird is composed of three curved lines that suggest movement and feathers. To the left of the bird, there is a circular arrangement of text, which appears to be the name of an organization or agency. The text is small and curves along the circle's perimeter.
10903 New Hampshire Avenue Silver Spring, MD 20993
SEP 2 3 2011
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia Regulatory Consultant LS! International Inc. 12828 Doe Lane Gaithersburg, MD 20878
Re: ki12071 Trade Name: Wondfo Methamphetamine Urine Test Wondfo Cocaine Urine Test Regulation Number: 21 CFR 862. 3610 Regulation Name: Methamphetamine test system Regulatory Class: Class H Product Codes: LAF, DIO Dated: September 7, 2011 Received: September 9, 2001
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 (2) 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 Viro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 800, 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/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 the rion the Drivall of (30) ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/ddf.go/17/90
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): | K112671 |
|---|---|
| --------------------------- | --------- |
Device Name: Wondfo Cocaine Urine Test
Indications for Use:
Wondfo Cocaine Urine Test is an immunochromatographic assay for the qualitative determination of Benzoylecgonine 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 X (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) K112071
Page 1 of 2
LSI International Inc.
5
Indications for Use Form
| 510(k) Number (if known): | K112071 |
|---|---|
| --------------------------- | --------- |
Device Name: Wondfo Methamphetamine Urine Test
Indications for Use:
Wondfo Methamphetamine Urine Test is an immunochromatographic assay for the qualitative determination of D(+)-Methamphetamine in human urine at a cutoff concentration of 1000 ng/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 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 X (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) K11207
Page 2 of 2
LSI International Inc.