(21 days)
Wondfo Multi-Drug Urine Test Cup and Woridfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Cocaine /COC | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCIMS 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.
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine samples. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
The provided document is a 510(k) premarket notification for the "Wondfo Multi-Drug Urine Test Cup" and "Wondfo Multi-Drug Urine Test Panel." This type of document focuses on establishing substantial equivalence to a predicate device, rather than defining specific acceptance criteria for performance metrics in the same way a de novo or PMA application might.
Therefore, the document does not contain explicit acceptance criteria and a study proving the device meets them in the format requested. It describes the device, its intended use, and classifies it based on existing regulations. It also mentions that the device is a "modified" product derived from previously FDA-cleared single DOA tests.
However, based on the information provided, we can infer some aspects and highlight what is missing:
Inferred Information based on provided text:
While explicit acceptance criteria are not stated, the document implies that the device's performance is gauged by its ability to qualitatively detect specific drugs at defined cut-off levels in human urine. The "comparison to the predicate device" section suggests that the device's design and likely its performance characteristics are substantially equivalent to previously cleared single-drug tests.
Missing Information (not present in the provided text):
The detailed information requested regarding specific acceptance criteria, study performance data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are not explicitly available in this summary.
Summary of missing information based on your request:
- A table of acceptance criteria and the reported device performance: Not explicitly provided. The cut-off levels are listed but without corresponding performance metrics (e.g., sensitivity, specificity, accuracy) that would demonstrate acceptance.
- Sample sized used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable/provided. This is a drug screening test, not an AI-assisted diagnostic imaging device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/provided. This is a biochemical assay.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The document mentions "GC/MS is the preferred confirmatory method," which implies Gas Chromatography/Mass Spectrometry is used as the ground truth for confirming drug presence and concentration.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not explicitly stated, but likely also through GC/MS, consistent with the confirmatory method for test results.
Conclusion:
The provided document is a regulatory submission demonstrating substantial equivalence for a multi-drug urine test, and as such, it focuses on classification, intended use, and comparison to predicate devices, rather than detailed performance data from a specific study against acceptance criteria. The performance data and acceptance criteria would typically be found in accompanying technical sections of the 510(k) submission, which are not included in this summary.
{0}------------------------------------------------
Premarket Notification - Guangzhou Wondfo Biotech Co. Ltd.
SUMMARY TABLE 4 March 16, 2012 1. Date the summary was prepared: Guangzhou Wondfo Biotech Co., Ltd. 2. Submitter's name: South China University of Technology Address: Guangzhou, P.R. China 510641 012-86-20-32296069 Phone: Joe Shia Name of contact person: 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 Multi-Drug Urine Test Cup Common or usual name: Multi-Drug Urine Test Panel Wondfo Multi-Drug Urine Test Cup Trade or proprietary name:
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
Wondfo Multi-Drug Urine Test Panel
| Product Code | CFR # |
|---|---|
| DIO | 21 CFR 862.3250 |
| LAF | 21 CFR 862.3610 |
| DJG | 21 CFR 862.3650 |
| DJR | 21 CFR 862.3620 |
| LFG | 21 CFR 862.3910 |
| LCM | 21 CFR 862.3100 |
- Description of the device:
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine samples. A positive urine sample will not generate a colored-line for the specific drug tested in the designated region. A negative urine specimen or a urine sample containing Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline at the concentration below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a test control, a color line will always appear at the control region.
-
- Intended use of the device:
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of:
- Intended use of the device:
| Drug(Identifier) | Cut-off level |
|---|---|
| Cocaine /COC | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
LSI International Inc.
. S
t
{1}------------------------------------------------
| Methadone (MTD) | 300 ng/mL |
|---|---|
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed 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.
6. Comparison to the predicate device
ﺮ ﺍ
ﮯ ﺗﺤﺮ
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are a "modified" product format derived from the previously FDA-cleared Wondfo single DOA Tests. The FDA-cleared device and the 510K number are listed in the following Table.
| Previously Cleared Wondfo DOA Tests | 510K Number | Product Code |
|---|---|---|
| Cocaine /COC | K112071 | DIO, LAF |
Wondfo Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 8 drugs of abuse tests while the predicate devices are single-drug test. And the Wondfo Multi-Drug Urine Test Panel is the same as the test dip card format of the predicate devices except that the Wondfo Multi-Drug Urine Test Panel is a multi-drug test that offers any combination from 2 to 8 drugs of abuse tests while the predicate devices are single-drug test.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular text element and a stylized symbol. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. To the right of the text is a symbol consisting of three stylized human profiles facing to the right.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration
10903 New Hampshire Avenue Silver Spring, MD 20993
Guangzhou Wondfo Biotech Co., LTD. c/o Joe Shia, LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877
MAY - 8 2012
K121166 Re:
K121100
Trade Name: Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel Regulation Number: 21 CFR §862.3250 Regulation Name: Cocaine Test System Regulatory Class: Class II Product Codes: DIO, LAF, LFG, LCM, DJR and DJG Dated: March 26, 2012
Received: April 17, 2012
Dear Mr. Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the We liave reviewed your Society of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices the indications for associated in a may 28, 1976, the enactment date of the marketed in merstate conmisive prodevices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require whill the provisions of the Federal Pool, 225, ...
approval of a premarket approval application (PMA). You may, therefore, which contracts approval of a promance approvisions of the Act. The general controls device, subject to the general comicements for annual registration, listing of devices, provisions of the Feetice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III ( If your device is classified (000 additional controls. Existing major regulations (CFF (PMA), If may be subject to such additions of Federal Regulations (CFR), Parts
affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts allecting your de vice can or round no 10.15 further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised that I DX 3 issualled of a believice complies with other not mean that PDA has made a dolorialism and regulations administered by other requirements of the Act of any I colorarians and its requirements, including, but not Federal agencies. Tourmust compty with and 07); labeling (21 CFR Parts 801 and limited to: registration and listing (21 OF R Parceleted adverse events) (21 809); medical device reporting (reporting (repression 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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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/Resourcesfor You/Industry/default.htm
Sincerely yours,
$\qquad$
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Premarket Notification ~ Guangzhou Wondfo Biotech Co. Ltd.
Indications for Use Form
510(k) Number (if known):
Device Name: Wondfo Multi-Drug Urine Test
Indications for Use:
Wondfo Multi-Drug Urine Test Cup and Woridfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Cocaine, Methadone, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Cocaine /COC | 300 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
Configuration of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GCIMS 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) K12.1166
§ 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).