(55 days)
Not Found
No
The device description details a lateral flow immunochromatographic assay, which is a chemical and biological test method, not a technology that typically incorporates AI/ML. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of these technologies.
No
The device is an in vitro diagnostic (IVD) device used for detecting various drugs in urine, providing preliminary test results. It does not provide any therapy or treatment.
Yes
The device is described as an "immunochromatographic assay for qualitative and simultaneous detection of Methamphetamine... in human urine" which provides "preliminary test results" for drug detection. This indicates its use in identifying the presence of specific substances in individuals, which falls under the definition of a diagnostic device.
No
The device description clearly indicates it is a physical, lateral flow immunochromatographic assay (test cup/panel) for detecting drugs in urine, which is a hardware-based diagnostic test.
Based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine". This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about the individual's health status (presence of drugs).
- Device Description: The description details a "lateral flow immunochromatographic assay" that analyzes "human urine samples". This further confirms the in vitro nature of the testing.
- Predicate Device: The mention of a predicate device (K112071; Wondfo single DOA Tests) which are typically IVDs, also supports this classification.
The core function of the device is to perform a diagnostic test on a biological sample in vitro, which aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
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
Methadone (MTD): 300 ng/mL
Phencyclidine (PCP): 25 ng/mL
Notriptyline (TCA): 1000 ng/mL
Oxycodone (OXY): 100 ng/mL
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 Notriptyline, 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.
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, Methadone, Phencyclidine, Notriptyline and Oxycodone in human urine at the cutoff concentrations of:
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
Methadone (MTD): 300 ng/mL
Phencyclidine (PCP): 25 ng/mL
Notriptyline (TCA): 1000 ng/mL
Oxycodone (OXY): 100 ng/mL
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 Notriptyline, 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)
DKZ, LDJ, DIO, LAF, DJR, LAF, DJG, LFG, JXM, DJG, LCM, DIS
Device Description
Wondfo Multi-Drug Urlne Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, immunochromatographic assays for qualitative and simultaneous detection of Methamphetamine, Cannabinoids, Oxazepam, Cocaine, Amphetamine, Secobarbital, Notriptyline and Methadone, Phencyclidine, Methylenedioxymethamphetamine, Morphine, Oxycodone 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 designation region. A negative urine specimen or a urine sample containing drugs below the cutoff levels will generate a color line in the 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
Prescription Use, 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
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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
NOV 1 5 2012
SIO(K)SUMMARY
-
Date the summary was prepared:
-
Submitter's name: Address:
Phone:
Name of contact person:
October 22, 2012 Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069 Joe Shia
LS! International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20877 Telephone: 240-505-7880 Fax: 301-916-6213
- Name of the device
| Common or usual name: | Multi-Drug Urine Test Cup
Multi-Drug Urine Test Panel |
|----------------------------|------------------------------------------------------------------------|
| Trade or proprietary name: | 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 | II | 21 CFR § 862.3100, Amphetamine | |
| Test System | Toxicology | ||
| (91) | |||
| LDJ | II | 21 CFR § 862.3870, Cannabinoids | |
| Test System | Toxicology | ||
| (91) | |||
| DIO | II | 21 CFR § 862.3250, Cocaine and | |
| Cocaine Metabolites Test System | Toxicology | ||
| (91) | |||
| LAF | II | 21 CFR § 862.3610, | |
| Methamphetamine Test System | Toxicology | ||
| (91) | |||
| DJR | II | 21 CFR § 862.3620, Methadone | |
| Test System | Toxicology | ||
| (91) | |||
| LAF | II | 21 CFR § 862.3610, | |
| Methylenedioxymet | |||
| hamphetamine Test System | Toxicology | ||
| (91) | |||
| DJG | II | 21 CFR § 862.3650, Morphine | |
| Test System | Toxicology | ||
| (91) | |||
| LFG | II | 21 CFR § 862.3910, Tricyclic | |
| antidepressant drug test system | Toxicology | ||
| (91) | |||
| JXM | II | 21 CFR § 862.3170, | |
| Benzodiazepine Test System | Toxicology | ||
| (91) | |||
| DJG | II | 21 CFR § 862.3650, Opiate Test | |
| System | Toxicology | ||
| (91) | |||
| LCM | unclassified | Enzyme Immunoassay | |
| Phencyclidine | Toxicology | ||
| (91) | |||
| DIS | II | 21 CFR § 862.3150, Barbiturate | |
| Test System | Toxicology | ||
| (91) |
1
4. Description of the device:
Wondfo Multi-Drug Urlne Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, Worldlo Mont-Drug Online Test Out and Vient Cualitative and simultaneous detection of Methamphetamine, Cannabinolds, Oxazepam, Cocaine, Amphetamine, Secobarbital, Notriptyline and Methadone, Phencyclidine, Mothylenedloxymethamphetamine, Morphine, Mathylenedioxymenamples. 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 designation of third. Creating region. A negative urine specimento a estomole containing Amphetamine, Secobarbital, Oxazepam,
region. A negative urine specimen or a urine sample containing, Mornhino, Mothe region. A negativ anno upetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Cocame, Califianninoids, Medianine, Methylononymenting warmer outoff levels will Prilence, Noulptyine and Oxybedile t.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, Wonds How immunochromatographic assays for qualitative and simultaneous detection of Methamphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Amphetamine, Phencyclidine, Notriptyline and Methadone, Methylenedioxymethamphetamine, Morphine, Oxycodone 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 |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 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 The use provides only premimary cover seen . GCMS or LCMS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription druge Nortriptyline, dasses. Clinial The test will yield prominary politive rested, even at or above therapeutic doses. Clicical 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
o. Comparison to the predicate device
Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are a "modified" profuct forma of Wolfied from the previously FDA-cleared Wondfo single DOA Tests. A summary comparison of features of derived from the previously FDA-Geared Worldfo Multi-Drug Urine Test Panel and the prodicate 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), Methadone (MTD),
Phencyclidine (PCP), Notriptyline (TCA), and/or
Oxycodone(OXY) 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
Methadone (MTD): 300 ng/ml
Phencyclidine (PCP): 25 ng/ml
Notriptyline (TCA): 1,000 ng/ml
Oxycodone(OXY): 100 ng/ml | Same |
| Configurations | Cup, dip card | Same |
| Intended Use | OTC Use & Prescription Use | Same |
ﺗﻢ ﺍﻟﻤﺮﺍﺟﻊ
Wondfo Multi-Drug Urine Test Cup is a multi-drug test that offers any combination from 2 to 12 drug Llrino Wondo Multi-Drug Office fest Oupla a multi artist and the Wondfo Multi-Drug Unine
of abuse tests while the predicate devices are single-drug the state the Wondfo Test Panel is the same as the test dip card format of the predicate devices except that the Wondfo Test Panel is the test Panel is a multi-drug test that offers any combination from 2 to 12:44
Multi-Drug Urine Test Panel ls a multi-drug test that offers any combination fro
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUM AN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 15, 2012
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878
Re: K122904
Trade/Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel Regulation Number: 21 CFR § 862.3250 Regulation Name: Cocaine and cocaine metabolite test system. Regulatory Class: Class II Product Code: DIO, DKZ, LDJ, LAF, DJR, DJG, LFG, JXM, LCM, DIS Dated: October 22, 2012 Received: October 25, 2012
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 Part 801); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Joe Shia
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.
If vou desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson
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
Indications for Use
510(k) Number (if known): K122904
Device Name: Wondfo Multi-Drug Urine Test Cup
Indications for Use:
Urine Test Cup is competitive binding, lateral flow Wondfo Multi-Drug detection for qualitative and simultaneous of immunochromatographic assay Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone 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 |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
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.
(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 Husca-Libs
Division Sign Off
Division Sign-0 Office of In Vitro Diagnostics and Radiological Health
510(k) KL22904
6
The test will yield preliminary positive results when prescription drugs Notriptyline, 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 Johnson-Lyles
Division Sign Off
ivision Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K22904
7
Indications for Use
510(k) Number (if known): K122904
Device Name: Wondfo Multi-Drug Urine Test Panel
Indications for Use:
Urine Test Panel is competitive binding, lateral flow Wondfo Multi-Drug immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Phencyclidine, Notriptyline and Oxycodone 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 |
| Methadone (MTD) | 300 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Notriptyline (TCA) | 1000 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
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.
(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 Ohunmgle
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122904
8
The test will yield preliminary positive results when prescription drugs Notriptyline, 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 Annon-Cyles
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K122904