(65 days)
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.
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.
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.
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.
This document is a 510(k) premarket notification for the "Wondfo Cocaine Urine Test" and "Wondfo Methamphetamine Urine Test." While it describes the intended use and summarizes a comparison to a predicate device, it does not contain a detailed study report with acceptance criteria and specific performance data that directly addresses the prompt's request for a study proving the device meets acceptance criteria.
The provided text focuses on demonstrating substantial equivalence to a legally marketed predicate device (Acon Laboratories, Inc. One Step Drug Screen Test, K020771) based on similar technological characteristics and intended use. Performance data is not elaborated upon in this summary section, which is typical for the summary portion of a 510(k) submission.
Therefore, I cannot provide all the requested information as it is not present in the given text.
Here's what can be extracted based on the provided text, and what is missing:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy percentages) for clinical studies, nor does it report detailed performance results from such studies. Instead, it focuses on demonstrating equivalence to the predicate device.
The closest to "performance" stated is the "Cut Off Values" for the qualitative determination of the substances:
| Substance | Cut-Off Value |
|---|---|
| Cocaine | 300 ng/ml |
| Methamphetamine | 1000 ng/ml |
The document states, "The Wondfo Cocaine Urine Test and Wondfo Methamphetamine Urine Test have similar technological characteristics and performance to the predicate and are equivalent." However, it does not provide the specific performance data proving this equivalence in the form of a study.
Missing Information (Not Available in the Provided Text)
The following information is not available in the provided 510(k) summary:
- 1. A table of acceptance criteria and the reported device performance: While cut-off values are given, specific performance metrics (e.g., sensitivity, specificity, PPV, NPV) and acceptance thresholds for those metrics are not provided.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No details on sample size or data collection are given.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- 4. Ground Truth Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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 is an immunoassay, not an AI-assisted diagnostic tool, so an MRMC study is not applicable.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as described above. The device performs a qualitative determination.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While it states "GC/MS is the preferred confirmatory method," the method used to establish ground truth for any specific study dataset is not described.
- 8. The sample size for the training set: Not mentioned (and likely not applicable in the same way as an AI algorithm, as this is a biochemical assay).
- 9. How the ground truth for the training set was established: Not mentioned.
Summary of Device and Study Context (based on available info):
This document describes a "Wondfo Cocaine Urine Test" and "Wondfo Methamphetamine Urine Test" as immunochromatographic assays for the qualitative detection of Benzoylecgonine and D(+)-Methamphetamine in human urine, respectively. The tests are intended for healthcare professional use and over-the-counter use in dip card and cup formats. The 510(k) submission aims to establish substantial equivalence to a predicate device (Acon Laboratories, Inc. One Step Drug Screen Test, K020771) by highlighting similar assay principle, methodology, test type, results, specimen type, and cut-off values. The preferred confirmatory method for positive results is GC/MS. The document does not provide the detailed study information as requested.
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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 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 20878Telephone: 240-505-7880Fax: 301-916-6231 | |
| 3. Name of the device | ||
| Common or usual name: | Cocaine Urine TestMethamphetamine Urine Test | |
| Trade or proprietary name: | Wondfo Cocaine Urine TestWondfo 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) foruse | For the qualitative determination ofCocaine, Methamphetamine individualin human urine. | Same (but the numberof drugs detecteddifferent) |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based | Same |
Table 1: Features comparison of Wondfo assays and the predicate devices
LSI International Inc.
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| on the principle of antigen antibodyimmunochemistry. | ||
|---|---|---|
| Type Of Test | Immunoassay principles that rely onantigen-antibody interactions toindicate positive or negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Cocaine:300 ng/mlMethamphetamine:1000 ng/ml | Same (but the numberof drugs detecteddifferent) |
| Configurations | Cup, dip card | Card, dip card with anintegrated 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.
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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).
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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 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
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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.
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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.
§ 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).