(21 days)
Not Found
No
The device description and intended use clearly describe a standard immunochromatographic assay (lateral flow test) for qualitative detection of substances in urine. There is no mention of AI, ML, image processing, or any computational analysis beyond the simple visual interpretation of a test line.
No.
This device is an in vitro diagnostic (IVD) test intended for the qualitative determination of specific substances (Phencyclidine and Notriptyline) in human urine, not for treating or preventing a disease or condition.
Yes
The device is intended for the "qualitative determination" of substances in human urine, which is a form of diagnostic testing to identify the presence or absence of specific analytes.
No
The device description explicitly states it is an "immunochromatograph assay" using a "lateral flow, one step system" and describes physical components like "monoclonal antibody-dye conjugate" and "membrane," indicating it is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "qualitative determination of Phencyclidine and Notriptyline (target analytes) at the specific cut-off concentration in human urine." This involves testing a sample taken from the human body (urine) in vitro (outside the body) to provide information about the individual's health status (presence of these substances).
- Device Description: The description details an "Immunochromatograph assay" which is a common type of test performed in vitro on biological samples.
- Anatomical Site: The sample is "human urine," which is a biological specimen.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wondfo Phencyclidine Urine Test and Wondfo Phencyclidine Urine are intended for the qualitative determination of Phencyclidine and Notriptyline (target analytes)at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 25ng/mL. The test is available in a dip card format and a cup 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. 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.
Wondfo Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 ng/mL. The test is available in a dip card format. It is intended for prescription use and over the counter use. The tests will yield preliminary positive results when the prescription drug Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Nortriptyline in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or HPLC 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.
Product codes (comma separated list FDA assigned to the subject device)
LCM, LFG
Device Description
Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against 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.)
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
§ 862.3910 Tricyclic antidepressant drugs test system.
(a)
Identification. A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.(b)
Classification. Class II (special controls). A tricyclic antidepressant drugs 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
K 112395
TABLE 4
SUMMARY
SEP - 9 2011
- Date the summary was prepared:
September 2, 2011
- 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
- Name of the device
| Common or usual name: | Phencyclidine Urine Test |
|---|---|
| Notriptyline Urine Test | |
| Trade or proprietary name: | Wondfo Phencyclidine Urine Test |
| Wondfo Notriptyline Urine Test |
Classification: All are Class II medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| LCM | 21CFR 862.3100 |
| LFG | 21CFR 862.3910 |
- The legally marketed devices to which we are claiming equivalence [807.92(a)(3)]:
1). Acon Laboratories, Inc., ACON® One Step Drug Screen Test, K020771.
2). Acon Laboratories, Inc., Acon® TCA One Step Tricyclic Antidepressant Test, K021526
- Description of the device:
Assay Principle: Immunochromatograph assay for Phencyclidine and Notriptyline Urine Test using a lateral flow, one step system for the qualitative detection of Phencyclidine and Notriptyline (target analytes) in human urine. Each assay uses a monoclonal antibody-dye conjugate from mouse against drug with gold chloride and fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane.
1
6. Intended use of the device:
Wondfo Phencyclidine Urine Test and Wondfo Phencyclidine Urine are intended for the qualitative determination of Phencyclidine and Notriptyline (target analytes)at the specific cut-off concentration in human urine. They are intended for healthcare professional use and over the counter use.
7. Comparison to the predicate device
A summary comparison of the features of the Wondfo Phencyclidine Urine Test and Wondfo Notriptyline Urine Test and the predicate devices is provided in the Table 1.
| Item | Device | Predicate |
|---|---|---|
| Indication(s) for | ||
| use | For the qualitative determination of | |
| Phencyclidine, Notriptyline individual in | Same (but the number | |
| of drugs detected | ||
| different) | ||
| human urine. | ||
| 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 | PCP: 25 ng/ml | |
| TCA: 1000 ng/ml | Same (but the number | |
| of drugs detected | ||
| different) | ||
| Configurations | Cup, dip card | Card, dip card with an |
| integrated cup (same) | ||
| Intended Use | OTC Use & Prescription Use | Prescription Use |
Table 1: Features comparison of Wondfo assays and the predicate devices
The Wondfo Phencyclidine Urine Test and Wondfo Notriptyline Urine Test have similar technological characteristics and performance to the predicate and are equivalent.
2
Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right. The eagle is depicted in a simple, line-art style.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Guangzhou Wondfo Biotech Co., Ltd. c/o Joe Shia LSI International Inc 504 East Diamond Ave, Suite F Gaithersburg, MD 20878
Re: K112395
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
SEP - 9 2011
Trade/Device Name: Wondfo Nortriptyline Urine Test and Wondfo Phencyclidine Urine
Transe on and Tort Test Regulation Number: 21 CFR 862.3910 Regulation Name: Tricyclic antidepressant drug test system Regulatory Class: Class II Product Code: LFG, LCM Dated: August 15, 2011 Received: August 19, 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 stars in the enclosure) to legally marketed predicated devices marketed in interstate comments on the endoming to regally marketed procession
Medical Device American and control on 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. Code of Federal Regulations
800 to 895. In addition, EDA more of little 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) (2) CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801), please contact the Office of In Viro Diagnosic Device Or Jour Gevery at (30) ) 796-5450. Also, please con
regulation entitled. "Mishranding by reference to manages in a monglesse note the regulation entitled, "Mishranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biomeric's (OBB's) Division of Postmarket Surveillance at (30) 796-5760. For questions regarding the reporting of 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 on your responsibilities under (be Act from the Division of Small
Manufacturers, International and Consumer Assistance at is toll-free number (80 560 ) 770 | Technicean and Collumics Assistance at its toll-free number (800) 638-204) or ( 301 ) 796)
5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resou
Sincerely yours,
signature
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K112395
Device Name: Wondfo Phencyclidine Urine Test
Indications for Use:
Wondfo Phencyclidine Urine Test is an immunochromatographic assay for the qualitative determination of Phencyclidine in human urine at a cutoff concentration of 25ng/mL. The test is available in a dip card format and a cup 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. 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) K112395
5
Indications for Use Form
510(k) Number (if known): K112395
Device Name: Wondfo Notriptyline Urine Test
Indications for Use:
Wondfo Notriptyline Urine Test is an immunochromatographic assay for the qualitative determination of Notriptyline (major metabolite of Tricyclic Antidepressants) in human urine at a cutoff concentration of 1000 ng/mL. The test is available in a dip card format. It is intended for prescription use and over the counter use. The tests will yield preliminary positive results when the prescription drug Nortriptyline are ingested, even at or above therapeutic doses. There are no uniformly recognized drug levels for Nortriptyline in urine.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a conformed analytical result. GC/MS or HPLC 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 Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K-112395
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