(321 days)
Not Found
No
The device description and performance studies describe a standard immunochromatographic assay (lateral flow test) and its analytical performance, with no mention of AI or ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is an in vitro diagnostic test for the qualitative determination of specific drugs in human urine. It is used for diagnosis and monitoring, not for treating a disease or condition.
Yes
The product's intended use is for the "qualitative determination" of substances (Buprenorphine, Oxycodone, d-Propoxyphene) in human urine, which directly falls under the definition of diagnosing or detecting the presence of specific substances.
No
The device description clearly states it is an "Immunochromatographic assay for drugs of abuse using a lateral flow, one step system" and describes physical components like "monoclonal antibody-dye congugate" and "fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane." This indicates a hardware-based test strip, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the qualitative determination of substances (Buprenorphine, Oxycodone, d-Propoxyphene) in a human specimen (urine). This is a core characteristic of IVDs.
- Device Description: The description details an immunochromatographic assay using a lateral flow system for the detection of drugs in human urine. This is a common technology used in IVD tests.
- Specimen Type: The device analyzes human urine, which is a biological specimen.
- Purpose: The purpose is to provide information about the presence of specific drugs in the body, which is used for diagnostic or screening purposes.
- Performance Studies: The document describes performance studies conducted to evaluate the accuracy and characteristics of the device using clinical urine specimens. This is a requirement for IVD devices to demonstrate their reliability.
- Predicate Devices: The mention of predicate devices (other similar tests that have been cleared by regulatory bodies) further indicates that this device falls under the category of IVDs.
The fact that it's intended for healthcare professionals in a central laboratory setting and not for point-of-care use doesn't change its classification as an IVD. It simply specifies the intended use environment.
N/A
Intended Use / Indications for Use
The Wondfo One Step Buprenorphine Urine Test Strip is intended for the qualitative determination of buprenorphine in human urine at the cut-off concentration of 10 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatographylmass spectrometry (GCMS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
The Wondfo One Step Oxycodone Urine Test Strip is intended for the qualitative determination of oxycodone in human urine at the cut-off concentration of 100 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
The Wondfo One Step Propoxyphene Urine Test Strip is intended for the qualitative determination of propoxyphene in human urine at the cut-off concentration of 300 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatographylmass spectrometry (GCMS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
Product codes (comma separated list FDA assigned to the subject device)
DJG, JXN
Device Description
Immunochromatographic assay for drugs of abuse using a lateral flow, one step system for the qualitative detection of specific drugs in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human urine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals in a central laboratory setting only and that it is not for use in point-of-care settings.
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
Sample description: Unaltered clinical urine samples were evaluated. The testing samples include a total of 80 samples (40 negative and 40 positive) for each drug. Originally 25 drug clinical samples of varying concentrations were from Cutoff Value section, 10 negative samples and additional 45 clinical samples were from Shenzhen Drug Addiction Recovery Center. All these samples concentration were confirmed by GC-MS. The concentrations of drug urine samples range from +50%cutoff.
Number of study sites: one Type of study site: Our internal facility Operator description: Our internal staff
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Accuracy
Sample Size: 240 (eighty of each drug) clinical urine specimens were analyzed by GC-MS and by each corresponding Wondfo one step drug of abuse test. Each Wondfo test was read by three viewers.
Key Results:
Buprenorphine Method Comparison Study Results
Viewer A: % agreement among positives is 90% (95% Confidence Interval 74.5% - 100%), % agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer B: % agreement among positives is 90% (95% Confidence Interval 74.5% - 100%), % agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer C: % agreement among positives is 90% (95% Confidence Interval 74.5% - 100%), % agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)
Oxycodone Method Comparison Study Results
Viewer A: % agreement among positives is 95% (95% Confidence Interval 79.5% - 100%), % agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer B: % agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%), % agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer C: % agreement among positives is 90% (95% Confidence Interval 74.5% - 100%), % agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)
Propoxyphene Method Comparison Study Results
Viewer A: % agreement among positives is 90% (95% Confidence Interval 74.5% - 100%), % agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer B: % agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%), % agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer C: % agreement among positives is 87.5% (95% Confidence Interval 72.0% - 100%), % agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)
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
Premarket Notification - Guangzhou Wondfo Biotech Co. Ltd.
510(k) SUMMARY AS REQUIRED BY SECTION 807.92(C)
K093175 AUG 25 2010
-
Date the summary was prepared: August 18, 2010
-
Submitter's name: Address:
Phone: Fax:
Guangzhou Wondfo Biotech Co., Ltd. South China University of Technology Guangzhou, P.R. China 510641 00-86-20-8711-1274-8999 00-86-20-8711-1434
Name of contact person:
Howard Mann SHERBO ASSOCIATES 1 Congressional Drive, Apt. C, Greenville, DE 19807 Phone: 215-369-3785 Fax: 215-369-5246 Email: sheryl@sherboassociates
- Name of the device
Common or usual name:
Immunochromatographic test for the qualitative detection of: Buprenorphine Oxycodone Propoxyphene
Trade or Proprietary or model name:
| Trade or Proprietary or model name | Model Number |
|---|---|
| 1. Wondfo One Step Buprenorphine Urine Test Strip | W13-S |
| 2. Wondfo One Step Oxycodone Urine Test Strip | W21-S |
| 3. Wondfo One Step Propoxyphene Urine Test Strip | W57-S |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| DJG | 21CFR 862.3650 |
| DJG | 21CFR 862.3650 |
| JXN | 21CFR 862.3700 |
-
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
-
Acon Laboratories, Inc. Acon BUP One Step Buprenorphene Test Strip, K060466.
-
Acon Laboratories, Inc. Acon OXY One Step Oxycodone Test Strip, K033047
-
Acon Laboratories, Inc. Acon PPX One Step Propoxyphene Test Strip, K040445
1
5. Description of the device:
Assay Principle: Immunochromatographic assay for drugs of abuse using a lateral flow, one step system for the qualitative detection of specific drugs in human urine. Each assay uses a monoclonal antibody-dye congugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse lgG polyclonal antibody in membrane.
6. Intended use of the device:
Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, and Wondfo One Step Propoxyphene Urine Test Strip are intended for the qualitative determination of Buprenorphine, Oxycodone, d-Propoxyphene at the specific cut-off concentration in human urine. They are intended for healthcare professionals in a central laboratory setting only and that it is not for use in point-of-care settings.
7. Comparison to the predicate device
A summary comparison of the features of the Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, Wondfo One Step Propoxyphene Urine Test Strip and the predicate devices Is provided in the Table 1.
| Similarities | ||
|---|---|---|
| Item | Device | Predicate |
| Intended Use | Same | For the qualitative determination of buprenorphine, |
| oxycodone, propoxyphene individual in human urine. | ||
| Calibrator | Same | Buprenorphine (buprenorphine) |
| Oxycodone (oxycodone) | ||
| Propoxyphene (propoxyphene) | ||
| Methodology | Same | Competitive binding, lateral flow |
| immunochromatographic assays based on the | ||
| principle of antigen antibody immunochemistry. | ||
| Type Of Test | Same | Immunoassay principles that rely on antigen-antibody |
| interactions to indicate positive or negative result | ||
| Specimen Type | Same | Human urine |
| Cut Off Values | Same | Buprenorphine (buprenorphine):10ng/ml |
| Oxycodone (oxycodone): 100 ng/ml | ||
| Propoxyphene (propoxyphene): 300 ng/ml | ||
| Configurations | Strip | Strip, Device |
Table 1: Features comparison of Wondfo assays and the predicate devices
8. Performance data
8.1 Accuracy
240 (eighty of each drug) clinical urine specimens were analyzed by GC-MS and by each corresponding Wondfo one step drug of abuse test. Each Wondfo test was read by three viewers. Samples were divided by concentration into four categories: less than half the cutoff, near cutoff negative, near cutoff
2
positive, and high positive.
Sample description: Unaltered clinical urine samples were evaluated. The testing samples include a total of 80 samples (40 negative and 40 positive) for each drug. Originally 25 drug clinical samples of varying concentrations were from Cutoff Value section, 10 negative samples and additional 45 clinical samples were from Shenzhen Drug Addiction Recovery Center. All these samples concentration were confirmed by GC-MS. The concentrations of drug urine samples range from +50%cutoff.
Number of study sites: one Type of study site: Our internal facility Operator description: Our internal staff
The following results are tabulated from comparison studies:
Buprenorphine Method Comparison Study Results
Viewer A:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 1 | 16 | 20 |
| Negative | 10 | 10 | 19 | 4 | 0 |
% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)
% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer B:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 2 | 16 | 20 |
| Negative | 10 | 10 | 18 | 4 | 0 |
% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)
% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer C:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 0 | 16 | 20 |
| Negative | 10 | 10 | 20 | 4 | 0 |
3
2
0
% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%) % agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)
Viewer A: Wondfo Negative Less than half Near Cutoff Near Cutoff High Positive Result the cutoff Negative Positive (greater than (Between the 50% above the concentration (Between 50% by GC/MS below the cutoff cutoff and 50% cutoff above the cutoff concentration) analysis and the cutoff concentration) concentration) 0 15 23 Positive 0 1
Oxycodone Method Comparison Study Results
10
10 % agreement among positives is 95% (95% Confidence Interval 79.5% - 100%)
% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer B:
Negative
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 2 | 14 | 23 |
| Negative | 10 | 10 | 18 | 3 | 0 |
19
% agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%)
% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer C:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 0 | 13 | 23 |
| Negative | 10 | 10 | 20 | 4 | 0 |
% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)
% agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%
Propoxyphene Method Comparison Study Results
Viewer A
| Viewer A. | |||||
|---|---|---|---|---|---|
| Wondfo | |||||
| Result | Negative | Less than half | |||
| the cutoff | |||||
| concentration | |||||
| by GC/MS | |||||
| analysis | Near Cutoff | ||||
| Negative | |||||
| (Between 50% | |||||
| below the cutoff | |||||
| and the cutoff | |||||
| concentration) | Near Cutoff | ||||
| Positive | |||||
| (Between the | |||||
| cutoff and 50% | |||||
| above the cutoff | |||||
| concentration) | High Positive | ||||
| (greater than | |||||
| 50% above the | |||||
| cutoff | |||||
| concentration) | |||||
| Positive | 0 | 0 | 2 | 17 | 19 |
| Negative | 10 | 16 | 12 | 4 | 0 |
% agreement among positives is 90% (95% Confidence Interval 74.5% - 100%)
4
% agreement among negatives is 95% (95% Confidence Interval 79.5% - 100%)
Viewer B:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 1 | 18 | 19 |
| Negative | 10 | 16 | 13 | 3 | 0 |
% agreement among positives is 92.5% (95% Confidence Interval 77.0% - 100%)
% agreement among negatives is 97.5% (95% Confidence Interval 82.0% - 100%)
Viewer C:
| Wondfo
Result | Negative | Less than half
the cutoff
concentration
by GC/MS
analysis | Near Cutoff
Negative
(Between 50%
below the cutoff
and the cutoff
concentration) | Near Cutoff
Positive
(Between the
cutoff and 50%
above the cutoff
concentration) | High Positive
(greater than
50% above the
cutoff
concentration) |
|------------------|----------|-----------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Positive | 0 | 0 | 0 | 16 | 19 |
| Negative | 10 | 16 | 14 | 5 | 0 |
% agreement among positives is 87.5% (95% Confidence Interval 72.0% - 100%)
% agreement among negatives is 100% (95% Confidence Interval 84.5% - 100%)
8.2 Performance Characteristics and Other information
The performance characteristics of the Wondfo One Step Buprenorphine Urine Test Strip, Wondfo One Step Oxycodone Urine Test Strip, and Wondfo One Step Propoxyphene Urine Test Strip were verified by cutoff value, specificity and cross-reactivity, interfering substances, effect of specified gravity of urine pH, precision, stability study. Study results indicate that these test devices are robust and can be stable during the shelf life time when used according to the package inserts.
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Guangzhou Wondfo Biotech Co., Ltd. c/o Mr. Howard Mann 1 Congressional Drive, Apt. C Greenville, DE 19807
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
AUG 25 2010
Re: K093175
Trade/Device Name: Wondfo One Step Bruprenorphine Urine Test Regulation Number: 21 CFR §862.3650 Regulation Name: Opiate Test System Regulatory Class: Class II Product Code: DJG, JXN Dated: August 20, 2010 Received: August 24, 2010
Dear Mr. Mann:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
6
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97): For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE FORM
510(k) Number (if known): · K093175
Device Name: Wondfo One Step Buprenorphine Urine Test Strip
Indication For Use: The Wondfo One Step Buprenorphine Urine Test Strip is intended for the qualitative determination of buprenorphine in human urine at the cut-off concentration of 10 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatographylmass spectrometry (GCMS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Doug Rheinheimer
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)
Page 1 of 3
8
INDICATIONS FOR USE.FORM
510(k) Number (if known): _K093175
Device Name: Wondfo One Step Oxycodone Urine Test Strip
Indication For Use: The Wondfo One Step Oxycodone Urine Test Strip is intended for the qualitative determination of oxycodone in human urine at the cut-off concentration of 100 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
Prescription Use __ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Doug Rheinhi
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
Kos3175 510(k)
Page 2 of 3
9
INDICATIONS FOR USE FORM
510(k) Number (if known): K093175
Device Name: Wondfo One Step Propoxyphene Urine Test Strip
Indication For Use: The Wondfo One Step Propoxyphene Urine Test Strip is intended for the qualitative determination of propoxyphene in human urine at the cut-off concentration of 300 ng/ml.
The assay is in strip format. The device is intended for healthcare professionals in a central laboratory setting only and is not for use in point-of-care settings. For in vitro diagnostic use.
This assay provides only a preliminary result. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. To obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas chromatographylmass spectrometry (GCMS) or Liquid chromatography/mass spectrometry (LC/MS) are the preferred confirmatory methods.
Prescription Use _ X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Dong Rheinheim
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) . k 09 3175
Page 3 of 3