(28 days)
Not Found
No
The device description details a lateral flow immunochromatographic assay, which is a chemical test that relies on antibody-antigen binding and visual interpretation of colored lines. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No.
The device is a diagnostic test for the detection of drugs in urine, not a therapeutic device designed for treatment or therapy.
Yes
The device qualitatively detects multiple drugs in human urine, providing preliminary test results for substances indicating their presence in the body, which is a form of diagnosis.
No
The device is a lateral flow immunochromatographic assay, which is a physical test kit that uses chemical reactions to detect substances in urine. It is not a software-only device.
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 and simultaneous detection of [various drugs] in human urine." This indicates that the device is used to examine a specimen (human urine) taken from the human body to provide information about a physiological state (presence of drugs).
- Device Description: The description details a "competitive binding, lateral flow immunochromatographic assay," which is a common type of in vitro diagnostic test. It describes how the test works by detecting the presence or absence of specific substances (drugs) in the urine sample.
- Specimen Type: The device uses "human urine," which is a biological specimen taken from the body.
- Purpose: The purpose is to detect the presence of specific analytes (drugs) in the specimen, providing information about the individual's drug use.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
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 Amphetamine, Secobarbital, o Oxazepam, Cocaine, Cocaine, Connelinoids, Contraliae, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 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.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. 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)
DJG, DKZ, LDJ, DIO, LAF, JXM, LCM, DIS
Device Description
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 Oxazepam, Amphetamine, Secobarbital, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine samples. Wondfo Multi-Drug devices detect each of analytes on different strips.
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 containine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methylenedioxymethamphetamine, Morphine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine 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.
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
Not Found
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
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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
SIO (x)SUMMARY
March 6, 2013
012-86-20-32296069
1. Date the summary was prepared:
- Submitter's name: Address:
Phone:
Name of contact person:
Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20877 Telephone: 240-505-7880 Fax: 301-916-6213
Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology
Guangzhou, P.R. China 510641
11 130 66 5
3. Name of the device
Common or usual name:
Trade or proprietary name:
Multi-Drug Urine Test Cup Multi-Drug Urine Test Panel Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| DKZ | |||
| Amphetamine | II | 21 CFR § 862.3100, Amphetamine | |
| Test System | Toxicology | ||
| (91) | |||
| LDJ | |||
| Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids | |
| Test System | Toxicology | ||
| (91) | |||
| DIO | |||
| Cocaine | II | 21 CFR § 862.3250, Cocaine and | |
| Cocaine Metabolites Test System | Toxicology | ||
| (91) | |||
| LAF | |||
| Methamphetamine | II | 21 CFR § 862.3610, | |
| Methamphetamine Test System | Toxicology | ||
| (91) | |||
| DJG | |||
| Morphine 2000 | II | 21 CFR § 862.3650, Morphine | |
| Test System | Toxicology | ||
| (91) | |||
| LAF | |||
| Methylenedioxymet | |||
| hamphetamine | II | 21 CFR § 862.3610, | |
| Methamphetamine Test System | Toxicology | ||
| (91) | |||
| DJG | |||
| Morphine | |||
| Buprenorphine | II | 21 CFR § 862.3650, Morphine | |
| Test System | Toxicology | ||
| (91) | |||
| DJG | |||
| JXM | |||
| Oxazepam | II | 21 CFR § 862.3170, | |
| Benzodiazepine Test System | Toxicology | ||
| (91) | |||
| DJG | |||
| Oxycodone | II | 21 CFR § 862.3650, Opiate Test | |
| System | Toxicology | ||
| (91) | |||
| LCM | |||
| Phencyclidine | .unclassified | Enzyme Immunoassay | |
| Phencyclidine | Toxicology | ||
| (91) | |||
| DIS | |||
| Secobarbital | II | 21 CFR § 862.3150, Barbiturate | |
| Test System | Toxicology | ||
| (91) |
APR 0 9 2013
1
1
4. 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 Oxazepam, Amphetamine, Secobarbital, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine samples. Wondfo Multi-Drug devices detect each of analytes on different strips.
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 containine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methylenedioxymethamphetamine, Morphine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine 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.
5. 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 Amphetamine, Secobarbital, o Oxazepam, Cocaine, Cocaine, Connelinoids, Contraliae,
Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
| Drug (Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 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.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. 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
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. A summary comparison of features of the Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel and the predicate devices is provided in the following Table
| Item | New Devices | Predicate devices (K112071) |
|---|---|---|
| Indication(s) for | ||
| use | For the qualitative determination of Amphetamine | |
| (AMP), Secobarbital (BAR), Oxazepam (BZO), | ||
| Cocaine (COC), Cannabinoids (THC), | ||
| Methamphetamine (MET), | ||
| Methylenedioxymethamphetamine (MDMA) | For the qualitative determination of Cocaine | |
| (COC), or Methamphetamine (MET), in human | ||
| urine. | ||
| The configurations of the Predicate devices are |
2
| | Morphine (MOP), Morphine 2000 (OPI),
Phencyclidine (PCP), Oxycodone(OXY) and/or
Buprenorphine in human urine.
The configurations of the New Devices are
available in any combination of the above tests. | only available in single drug test. |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| 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 | Amphetamine (AMP): 1,000 ng/ml
Secobarbital(BAR): 300 ng/ml
Oxazepam (BZO):300 ng/ml
Cocaine(COC): 300 ng/ml
Cannabinoids (THC):50 ng/ml
Methamphetamine (MET): 1,000 ng/ml
Methylenedioxymethamphetamine (MDMA): 500
ng/ml
Morphine (MOP): 300 ng/ml
Morphine 2000 (OPI): 2000 ng/ml
Phencyclidine (PCP): 25 ng/ml
Oxycodone(OXY) : 100 ng/ml
Buprenorphine (BUP): 10 ng/ml | Same |
| Configurations | Cup, dip card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
Wondfo Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 12 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 12 drugs of abuse tests while the predicate devices are single-drug test.
3
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2013
GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA REGULATORY CONSULTANT 504E DIAMOND AVE:, SUITE F GAITHERSBURG MD 20877
Re: K130665
Trade/Device Name: Wondfo Multi-Drug Urine Test Cup, Wondfo Multi-Drug Urine Test Panel
Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, DKZ, LDJ, DIO, LAF, JXM, LCM, DIS Dated: March 06, 2013 Received: March 12, 2013
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carol Benson - S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K130665
Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Wondfo Multi-Drug Urine Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson#byles; -5
2013.04.09 08:334:30 =04:00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130665 510(k) =======================================================================================================================================================================
Page 1 of 4
6
510(k) Number (if known): K130665 .
Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Configuration of the Wondfo Multi-Drug Urine Test Cup 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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses.
Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnson Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
v v
K130665 510(k) =
7
510(k) Number (if known): K130665
Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Wondfo Multi-Drug Urine Test Panel is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Morphine 2000, Phencyclidine, Oxycodone and Buprenorphine in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine(AMP) | 1000 ng/mL |
| Secobarbital (BAR) | 300 ng/mL |
| Oxazepam (BZO) | 300 ng/mL |
| Cocaine (COC) | 300 ng/mL |
| Cannabinoids (THC) | 50 ng/mL |
| Methamphetamine (MET) | 1000 ng/mL |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL |
| Morphine (MOP) | 300 ng/mL |
| Morphine 2000 (OPI) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Denise Johnsonslyless 55
2013.04.09 08:35:118504.00 Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130665
Page 3 of _4
8
510(k) Number (if known): K130665
Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Configuration of the 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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic doses. 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 Diagnostics and Radiological Health (OIR)
Denise John ธรุงกรุปyless -S 2013.04.09 08:35:48 204'00'
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K130665