(61 days)
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, 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.
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.
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.
The provided document, K133968, is a 510(k) premarket notification for the Wondfo Multi-Drug Urine Test Cup and Panel, dated February 25, 2014. This document details the device's characteristics, intended use, and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or the study that proves the device meets those criteria in the way typically expected for a diagnostic AI study.
The submission focuses on establishing substantial equivalence by demonstrating that the new multi-drug device combines individually cleared drug tests. The "Performance Characteristics" section explicitly states that the "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." This indicates that the performance data for each individual drug test component was referenced from prior 510(k) clearances, rather than a new, comprehensive study detailed within this specific document for the combined device meeting new acceptance criteria.
Therefore, for aspects of the prompt related to specific study details (sample size, data provenance, ground truth establishment, expert involvement, MRMC studies, standalone performance), the document points to external references (the prior 510(k) submissions for individual drug tests).
Here's a breakdown of the requested information based on the provided text, with clear indications where information is not present or refers to external documents:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in terms of specific sensitivity/specificity thresholds or concordance rates for the multi-drug device itself. Instead, it relies on the established performance of the individual drug tests that were previously cleared.
The "reported device performance" for the combined multi-drug test relates to its ability to perform qualitatively for each drug at specified cut-off levels, demonstrating substantial equivalence to predicate devices. The performance is implied to be acceptable if the individual components were acceptable.
| Drug (Identifier) | Cut-off level | Reported Device Performance (Implied from prior clearances) |
|---|---|---|
| Amphetamine (AMP) | 1000 ng/mL | Qualitative detection at or above cut-off |
| Secobarbital (BAR) | 300 ng/mL | Qualitative detection at or above cut-off |
| Oxazepam (BZO) | 300 ng/mL | Qualitative detection at or above cut-off |
| Cocaine (COC) | 300 ng/mL | Qualitative detection at or above cut-off |
| Cannabinoids (THC) | 50 ng/mL | Qualitative detection at or above cut-off |
| Methamphetamine (MET) | 1000 ng/mL | Qualitative detection at or above cut-off |
| Methylenedioxymethamphetamine (MDMA) | 500 ng/mL | Qualitative detection at or above cut-off |
| Morphine (MOP) | 300 or 2000 ng/mL* | Qualitative detection at or above cut-off |
| Phencyclidine (PCP) | 25 ng/mL | Qualitative detection at or above cut-off |
| Oxycodone (OXY) | 100 ng/mL | Qualitative detection at or above cut-off |
| Buprenorphine (BUP) | 10 ng/mL | Qualitative detection at or above cut-off |
| Methadone (MTD) | 300 ng/mL | Qualitative detection at or above cut-off |
| Notriptyline (TCA) | 1000 ng/mL | Qualitative detection at or above cut-off |
*Note: Morphine is listed with two cut-off levels (300 ng/mL and 2000 ng/mL for "Morphine 2000 (OPI)") linked to different 510(k) numbers. The general indication for use lists 300 ng/mL.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not detailed in the provided summary document directly for the multi-drug cup/panel. The document states "Analytical performance was established for each device in the submissions as stated below," and then lists the 510(k) numbers for individual drug tests. To find the sample sizes and data provenance, one would need to review each of those referenced 510(k) submissions (e.g., K121987 for Amphetamine, Secobarbital, Oxazepam).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not detailed in the provided summary document. For drug screening tests like these, ground truth is typically established by definitive laboratory methods (e.g., GC/MS, LC/MS), not by human expert consensus or interpretation of the test device itself. The document explicitly states: "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."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/detailed for this type of device and study. Adjudication methods are typically used in studies involving human readers and interpretations, often in imaging or clinical scenarios where expert opinion might differ. For a lateral flow immunochromatographic assay, the result (presence/absence of a line) is typically objective, and confirmation is done via definitive analytical methods.
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
No MRMC study was done or is applicable as this is a qualitative in vitro diagnostic device (IVD) for drug detection, not an AI-assisted diagnostic tool that human readers would interpret.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test (an immunochromatographic assay). Its performance is the direct result of the assay's chemical reactions, not an algorithm. The reading of the test involves human interpretation of a visual line, but the "performance" described refers to the chemical assay's ability to trigger that visual line based on drug concentration. The document emphasizes the need for confirmatory chemical methods (GC/MS, LC/MS).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The type of ground truth for these tests is definitive chemical analysis, specifically GC/MS (Gas Chromatography/Mass Spectrometry) or LC/MS (Liquid Chromatography/Mass Spectrometry). The document explicitly states: "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."
8. The sample size for the training set
This information is not applicable as this device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable as this device is a chemical immunoassay, not an AI/machine learning algorithm that requires a "training set."
{0}------------------------------------------------
FEB 2 5 2014 K 133968
SUMMARY
| 1. Date the summary was prepared: | |||
|---|---|---|---|
- 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: 240-505-7880 Fax: 301-916-6213
February 11, 2014
3. Name of the device
| Common or usual name: | Multi-Drug Urine Test Cup Multi-DrugUrine Test Panel |
|---|---|
| Trade or proprietary name: | Wondfo Multi-Drug Urine Test CupWondfo 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 |
|---|---|---|---|
| DKZAmphetamine | II | 21 CFR § 862.3100, AmphetamineTest System | Toxicology(91) |
| LDJCannabinoids | II | 21 CFR § 862.3870, CannabinoidsTest System | Toxicology(91) |
| DIOCocaine | II | 21 CFR § 862.3250, Cocaine andCocaine Metabolites Test System | Toxicology(91) |
| LAFMethamphetamine | II | 21 CFR § 862.3610,Methamphetamine Test System | Toxicology(91) |
| LAFMethylenedioxymethamphetamine | II | 21 CFR § 862.3610,Methamphetamine Test System | Toxicology(91) |
| DJGMorphine | II | 21 CFR § 862.3650, MorphineTest System | Toxicology(91) |
| BuprenorphineDJG | II | 21 CFR § 862.3650, Opiate testsystem | Toxicology(91) |
| JXMOxazepam | II | 21 CFR § 862.3170,Benzodiazepine Test System | Toxicology(91) |
| DJGOxycodone | II | 21 CFR § 862.3650, Opiate TestSystem | Toxicology(91) |
| LCMPhencyclidine | unclassified | Enzyme ImmunoassayPhencyclidine | Toxicology(91) |
| DISSecobarbital | II | 21 CFR § 862.3150, BarbiturateTest System | Toxicology(91) |
| DJRMethadone | II | 21 CFR § 862.3620,Methadone Test System | Toxicology(91) |
{1}------------------------------------------------
| LFG | II | 21 CFR § 862.3910, Tricyclic antidepressant drug Test System | Toxicology(91) |
|---|---|---|---|
| Notriptyline |
- 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(K112071) |
|---|---|---|
| Indication(s) for use | For the qualitative determination of Amphetamine(AMP), Secobarbital (BAR), Oxazepam (BZO),Cocaine (COC), Cannabinoids (THC),Methamphetamine (MET),Methylenedioxymethamphetamine (MDMA),Morphine (MOP), Phencyclidine (PCP),Oxycodone(OXY), Buprenorphine (BUP),Methadone (MTD) and/or Notriptyline (TCA) inhuman urine.The configurations of the New Devices areavailable in any combination of the above tests. | For the qualitative determination ofCocaine (COC), orMethamphetamine (MET), inhuman urine.The configurations of the Predicatedevices areonly available in single drug test. |
| Methodology | Competitive binding, lateral flowimmunochromatographic assays based on theprinciple of antigen antibody immunochemistry. | Same |
| Type Of Test | Immunoassay principles that rely on antigen-antibody interactions to indicate positive ornegative result | Same |
| Results | Qualitative | Same |
| Specimen Type | Human urine | Same |
| Cut Off Values | Amphetamine (AMP): 1,000 ng/mlSecobarbital(BAR): 300 ng/mlOxazepam (BZO):300 ng/mlCocaine(COC): 300 ng/mlCannabinoids (THC):50 ng/mlMethamphetamine (MET): 1,000 ng/mlMethylenedioxymethamphetamine (MDMA): 500ng/mlMorphine (MOP): 300 ng/mlPhencyclidine (PCP): 25 ng/mlOxycodone(OXY): 100 ng/mlBuprenorphine (BUP): 10 ng/mlMethadone (MTD): 300 ng/mLNotriptyline (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(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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
§ 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).