(42 days)
Not Found
No
The description details a standard immunochromatographic assay (lateral flow test) which relies on chemical reactions and antibody binding, not AI/ML algorithms. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
This device is an in vitro diagnostic (IVD) test used to detect the presence of specific drugs in urine; it does not provide any therapy or treatment.
Yes
The intended use explicitly states "qualitative determination" of substances in human urine, which is a form of in vitro diagnostic testing.
No
The device description explicitly states it is an "Immunochromatograph assay" using a "lateral flow, one step system" with physical components like "monoclonal antibody-dve conjuqate" and "membrane." This indicates a physical test kit, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the tests are for the "qualitative determination of Amphetamine, Secobarbital, Oxazepam... in human urine." This involves testing a sample taken from the human body (in vitro) to diagnose or provide information about a person's health status (in this case, the presence of certain substances).
- Device Description: The description details an "Immunochromatograph assay" that uses a "lateral flow, one step system for the qualitative detection of Amphetamine, Secobarbital, and Oxazepam in human urine." This describes a laboratory-type test performed on a biological sample.
- Sample Type: The tests are performed on "human urine," which is a biological specimen.
These characteristics align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, and Wondfo Oxazepam Urine Test are intended for the qualitative determination of Amphetamine, Secobarbital, Oxazepam at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM
Device Description
Assay Principle: Immunochromatograph assay for Amphetamine, Secobarbital, and Oxazepam Urine Test using a lateral flow, one step system for the qualitative detection of Amphetamine, Secobarbital, and Oxazepam in human urine. Each assay uses a monoclonal antibody-dve conjuqate from mouse aqainst drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
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
healthcare professional use and 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.)
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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.
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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).
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§ 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
| TABLE 4 | SUMMARY |
|---|---|
| 1. Date the summary was prepared: | May 03, 2011 |
| 2. Submitter's name: | Guangzhou Wondfo Biotech Co., Ltd. |
| Address: | South China University of Technology |
| Guangzhou, P.R. China 510641 | |
| Phone: | 012-86-20-32296069 |
| Name of contact person: | Joe Shia |
| LSI International Inc. | |
| 504 East Diamond Ave., | |
| Suite F Gaithersburg, MD 20878 | |
| Telephone: 240-505-7880 | |
| Fax: 301-916-6231 | |
| 3. Name of the device | |
| Common or usual name: | Amphetamine Urine Test |
| Secobarbital Urine Test | |
| Oxazepam Urine Test | |
| Trade or proprietary name: | Wondfo Amphetamine Urine Test |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
Wondfo Secobarbital Urine Test Wondfo Oxazepam Urine Test
| Product Code | CFR # |
|---|---|
| DKZ | 21CFR 862.3100 |
| DIS | 21CFR 862.3150 |
| JXM | 21CFR 862.3170 |
-
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)]: Acon Laboratories, Inc. One Step Drug Screen Test Card, K020771.
-
- Description of the device:
Assay Principle: Immunochromatograph assay for Amphetamine, Secobarbital, and Oxazepam Urine Test using a lateral flow, one step system for the qualitative detection of Amphetamine, Secobarbital, and Oxazepam in human urine. Each assay uses a monoclonal antibody-dve conjuqate from mouse aqainst drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
-
- Intended use of the device:
Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, and Wondfo Oxazepam Urine Test are intended for the qualitative determination of Amphetamine, Secobarbital, Oxazepam at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
- Intended use of the device:
- Comparison to the predicate device
A summary comparison of the features of the Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, Wondfo Oxazepam Urine Test and the predicate devices is provided in the Table 1.
1
| Item | Device | Predicate |
|---|---|---|
| Indication(s) for | ||
| use | For the qualitative determination of | |
| Amphetamine, Secobarbital, Oxazepam | ||
| individual in human urine. | Same (but the number | |
| of drugs detected | ||
| different) | ||
| 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: 1000ng/ml | |
| Secobarbital: 300 ng/ml | ||
| Oxazepam: 300ng/ml | Same (but the number | |
| of drugs detected | ||
| different) | ||
| Configurations | Strip, cassette | Card |
| Intended Use | OTC Use & Prescription Use | Prescription Use |
| Table 1: Features comparison of Wondfo assays and the predicate devices | |
|---|---|
| ------------------------------------------------------------------------- | -- |
The Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, and Wondfo Oxazepam Urine Test have similar technological characteristics and performance to the predicate and are equivalent.
.
2
Image /page/2/Picture/0 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. To the right of the text is a stylized symbol that resembles a bird or a series of flowing lines. The symbol is black and appears to be in motion.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Guangzhou Wondfo Biotech Co., LTD. c/o Joe Shia, LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877
K111560 Re:
Trade Name: Wondfo Amphetamine Urine Test, Wondfo Secobarbital Urine Test, and Wondfo Oxazepam Urine Test Regulation Number: 21 CFR §862.3100 Regulation Name: Amphetamine Test System Regulatory Class: Class II Product Codes: DKZ, DIX, and JXM Dated: July6, 2011 Received: July 8, 2011
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 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).
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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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 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 tollefree no mber (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
C.C.
Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
: تركة :
Enclosure
4
Indications for Use Form
510(k) Number (if known): _ K111560
Device Name: _Wondfo Amphetamine Urine Test
Indications for Use:
Wondfo Amphetamine Urine Test is an immunochromatographic assay for the qualitative determination of d-Amphetamine in human urine at a cutoff concentration of 1000ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical method must be to obtain a conformed analytical result. GC/MS is the preferred confirmatory method. 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 Diagnostic Devices (OIVD)
Division Size Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) 111560
Page 1 of 3
5
Indications for Use Form
510(k) Number (if known): _ K111560
Device Name: Wondfo Secobarbital Urine Test
Indications for Use:
Wondfo Secobarbital Urine Test is an immunochromatographic assay for the qualitalive determination of Secobarbital (major metabolite of Barbiturates) in human urine at a cutoff concentration of 300ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GCMS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
Prescription Use __ × (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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111560
Page 2 of 3
6
Indications for Use Form
510(k) Number (if known): _ K111560
Device Name: Wondfo Oxazepam Urine Test
Indications for Use:
Wondfo Oxazepam Urine Test is an immunochromatographic assay for the qualitative determination of Oxazepam (major metabolite of Benzodiazepines) in human urine at a cutoff concentration of 300ng/mL. The test is available in a cassette format and a strip format. It is intended for prescription use and over the counter use.
The test provides only preliminary test results. A more specific alternative chemical method must to obtain a conformed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
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 Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K111360
Page 3 of_ 3