WONDFO MULTI-DRUG URINE TEST CUP, PANEL

K133968 · Guangzhou Wondfo Biotech Co., Ltd. · DKZ · Feb 25, 2014 · Clinical Toxicology

Device Facts

• Record ID: K133968
• Device Name: WONDFO MULTI-DRUG URINE TEST CUP, PANEL
• Applicant: Guangzhou Wondfo Biotech Co., Ltd.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Feb 25, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended 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 Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Amphetamine, of Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of: [Table of cut-offs]. 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 must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. The test may vield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Story

Device modification combines previously cleared single-analyte drug-of-abuse (DOA) tests into multi-test device; detects 2 to 13 drugs simultaneously in human urine. Input: urine sample; principle: lateral flow immunoassay; output: qualitative visual result (presence/absence of drug). Used at point-of-care sites by healthcare professionals. Output assists clinicians in assessing patient drug compliance.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm performance characteristics of the multi-test format compared to single-analyte predicates.

Technological Characteristics

Lateral flow immunochromatographic assay; competitive binding principle. Form factors: test cup and test panel (dip card). Multi-analyte configuration (2-13 drugs). In vitro diagnostic use. No electronic components or software.

Indications for Use

Indicated for qualitative, simultaneous detection of drugs of abuse (Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, MDMA, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone, Notriptyline) in human urine. Intended for OTC and prescription use. Not intended to distinguish between prescription use and abuse.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Wondfo single DOA Tests (K112071)

Submission Summary (Full Text)

{0}------------------------------------------------

**FEB 2 5 2014** K 133968

## SUMMARY

| | | 1. Date the summary was prepared: | |
|--|--|-----------------------------------|--|
| | | | |

2. Submitter's name:

Phone:

Name of contact person:

Guangzhou Wondfo Biotech Co., Ltd. Address: South China University of Technology Guangzhou, P.R. China 510641 012-86-20-32296069

Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20877 Telephone: [phone] Fax: [phone]

February 11, 2014

#### 3. Name of the device

| Common or usual name: | Multi-Drug Urine Test Cup Multi-Drug<br>Urine Test Panel |
|----------------------------|------------------------------------------------------------------------|
| Trade or proprietary name: | Wondfo Multi-Drug Urine Test Cup<br>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<br>Amphetamine | II | 21 CFR § 862.3100, Amphetamine<br>Test System | Toxicology<br>(91) |
| LDJ<br>Cannabinoids | II | 21 CFR § 862.3870, Cannabinoids<br>Test System | Toxicology<br>(91) |
| DIO<br>Cocaine | II | 21 CFR § 862.3250, Cocaine and<br>Cocaine Metabolites Test System | Toxicology<br>(91) |
| LAF<br>Methamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology<br>(91) |
| LAF<br>Methylenedioxymethamphetamine | II | 21 CFR § 862.3610,<br>Methamphetamine Test System | Toxicology<br>(91) |
| DJG<br>Morphine | II | 21 CFR § 862.3650, Morphine<br>Test System | Toxicology<br>(91) |
| Buprenorphine<br>DJG | II | 21 CFR § 862.3650, Opiate test<br>system | Toxicology<br>(91) |
| JXM<br>Oxazepam | II | 21 CFR § 862.3170,<br>Benzodiazepine Test System | Toxicology<br>(91) |
| DJG<br>Oxycodone | II | 21 CFR § 862.3650, Opiate Test<br>System | Toxicology<br>(91) |
| LCM<br>Phencyclidine | unclassified | Enzyme Immunoassay<br>Phencyclidine | Toxicology<br>(91) |
| DIS<br>Secobarbital | II | 21 CFR § 862.3150, Barbiturate<br>Test System | Toxicology<br>(91) |
| DJR<br>Methadone | II | 21 CFR § 862.3620,<br>Methadone Test System | Toxicology<br>(91) |

{1}------------------------------------------------

| LFG | II | 21 CFR § 862.3910, Tricyclic antidepressant drug Test System | Toxicology<br>(91) |
|--------------|----|--------------------------------------------------------------|--------------------|
| Notriptyline | | | |

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 Secobarbital, Oxazepam, Cocaine, Cannabinoids. Methamphetamine, Amphetamine, of Methylenedioxymethamphetamine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline 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 containing Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and 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 procedural 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 Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Amphetamine, of Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline 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 or 2000ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methadone (MTD) | 300 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 must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method.

The test may vield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

#### 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

{2}------------------------------------------------

| Item | New Devices | Predicate devices<br>(K112071) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication(s) for use | For the qualitative determination of Amphetamine<br>(AMP), Secobarbital (BAR), Oxazepam (BZO),<br>Cocaine (COC), Cannabinoids (THC),<br>Methamphetamine (MET),<br>Methylenedioxymethamphetamine (MDMA),<br>Morphine (MOP), Phencyclidine (PCP),<br>Oxycodone(OXY), Buprenorphine (BUP),<br>Methadone (MTD) and/or Notriptyline (TCA) in<br>human urine.<br>The configurations of the New Devices are<br>available in any combination of the above tests. | For the qualitative determination of<br>Cocaine (COC), or<br>Methamphetamine (MET), in<br>human urine.<br>The configurations of the Predicate<br>devices are<br>only available in single drug test. |
| Methodology | Competitive binding, lateral flow<br>immunochromatographic assays based on the<br>principle of antigen antibody immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on antigen-<br>antibody interactions to indicate positive or<br>negative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/ml<br>Secobarbital(BAR): 300 ng/ml<br>Oxazepam (BZO):300 ng/ml<br>Cocaine(COC): 300 ng/ml<br>Cannabinoids (THC):50 ng/ml<br>Methamphetamine (MET): 1,000 ng/ml<br>Methylenedioxymethamphetamine (MDMA): 500<br>ng/ml<br>Morphine (MOP): 300 ng/ml<br>Phencyclidine (PCP): 25 ng/ml<br>Oxycodone(OXY): 100 ng/ml<br>Buprenorphine (BUP): 10 ng/ml<br>Methadone (MTD): 300 ng/mL<br>Notriptyline (TCA): 1000 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 13 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 13 drugs of abuse tests while the predicate devices are single-drug test.

### 7. Performance Characteristics

Clearance of candidate device is for combining various individual drug tests into a multi-drug test. Analytical performance was established for each device in the submissions as stated below.

{3}------------------------------------------------

| Drug(Identifier) | 510(K) # |
|-----------------------------------------|---------------------|
| Amphetamine(AMP) | K121987 |
| Secobarbital (BAR) | K121987 |
| Oxazepam (BZO) | K121987 |
| Cocaine (COC) | K112071 |
| Cannabinoids (THC) | K121557 |
| Methamphetamine (MET) | K112071 |
| Methylenedioxymethamphetamine<br>(MDMA) | K112236 |
| Morphine (MOP) | K112236 |
| Morphine 2000 (OPI) | K112310 |
| Phencyclidine (PCP) | K112395 |
| Oxycodone (OXY) | K113624 |
| Buprenorphine (BUP) | K113624 and K130055 |
| Methadone (MTD) | K112310 |
| Notriptyline (TCA) | K112395 |

## 8. Conclusion

Based on the test principle and performance characteristics of the device, it's concluded that Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are substantially equivalent to the predicate.

.

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of an eagle or bird with three curved lines representing its wings or feathers.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 25, 2014

GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20878

Re: K133968

Trade/Device Name: Wondfo Multi-drug Urine Test Cup, Panel Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: II Product Code: DKZ, DIS, JXM, DIO, LAF, LDJ, JXM, DJG, LFG, LCM, DJR Dated: January 21, 2014 Received: January 27, 2014

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

{5}------------------------------------------------

Page 2-Mr. Shia

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 [phone] or [phone] or at its botternet address http://www.fda.gov/MedicalDevices/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFF Peart 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Courtney H. Lias -S

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

{6}------------------------------------------------

## Indications for Use

510(k) Number (if known): k133968

## Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel

Indication For Use:

Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Cannabinoids, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline 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 |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methadone (MTD) | 300 ng/mL |
| Notriptyline (TCA) | 1000ng/mL |

Configuration of the Wondfo Multi-Drug Urine Test Cup can consist of any combination of the above listed drug analytes.

{7}------------------------------------------------

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 may yield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Prescription Use (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)

Avis T. Danishefsky -S Division Sign-Off

Office of In Vitro Diagnostics and Radiological Health

510(k): k133968_______________________________________________________________________________________________________________________________________________________________

{8}------------------------------------------------

# Indications for Use

510(k) Number (if known):k133968

Device Name: Wondfo Multi-Drug Urine Test Cup Wondfo Multi-Drug Urine Test Panel

Indication For Use:

Wondfo Multi-Drug Urine Test Cup and Wondfo Multi-Drug Urine Test Panel are competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine. Methamphetamine, Methylenedioxymethamphetamine, Morphine, Cannabinoids, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline 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) | 2000 ng/mL |
| Phencyclidine (PCP) | 25 ng/mL |
| Oxycodone (OXY) | 100 ng/mL |
| Buprenorphine (BUP) | 10 ng/mL |
| Methadone (MTD) | 300/ng/mL |

Configuration of the Wondfo Multi-Drug Urine Test Panel can consist of any combination of the above listed drug analytes.

{9}------------------------------------------------

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 may vield positive results for the prescription drugs buprenorphine, oxazepam, oxycodone, and secobarbital when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs.

Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Prescription Use X (21 CFR Part 801 Subpart D) Over the Counter Use X (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Avis T. Danishefsky -S Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) k133968