(61 days)
Not Found
No
The device description details a standard immunochromatographic assay, which relies on chemical reactions and visual interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic test for detecting substances in urine, not a device used for therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "For in vitro diagnostic use only." This phrase directly indicates that the device is used for diagnostic purposes.
No
The device description clearly states it is an "Immunochromatograph assay" using a "lateral flow, one step system" with physical components like "monoclonal antibody-dye conjugate" and "membrane," indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For in vitro diagnostic use only."
- Nature of the Test: The device performs a qualitative determination of specific substances (cannabinoids and propoxyphene) in a human biological sample (urine). This is a core characteristic of in vitro diagnostics, which are used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The description details an "Immunochromatograph assay," which is a common type of test used in IVD devices.
The information provided strongly indicates that this device is intended to be used outside of the body to diagnose or provide information about a person's health status based on the analysis of a biological sample.
N/A
Intended Use / Indications for Use
Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are intended for the qualitative determination of 11-nor-A9-THC-9-COOH and d-propoxyphene (target analyte) at the specific cut-off concentration in human urine. For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription use.
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. This product is only intended for prescription 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 Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/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 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.
Product codes (comma separated list FDA assigned to the subject device)
LDJ, JXN
Device Description
Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (target analyte) 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 IqG 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
For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription 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
§ 862.3870 Cannabinoid test system.
(a)
Identification. A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.(b)
Classification. Class II (special controls). A cannabinoid 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
| 1. Date the summary was prepared: | July 18, 2012 | JUL 2 5 2012 |
|---|---|---|
| 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: 301-916-6213 | ||
| 3. Name of the device | Wondfo Cannabinoids Urine Test | |
| Wondfo Propoxyphene Urine Test | ||
| Common or usual name: | Cannabinoids Urine Test | |
| Propoxyphene Urine Test | ||
| Trade or proprietary name: | Wondfo Cannabinoids Urine Test | |
| Wondfo Propoxyphene Urine Test |
Classification: All are Class medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| LDJ | 21 CFR 862.3870 |
| JXN | 21 CFR 862.3700 |
-
The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:
-
Acon Laboratories, Inc. ACON One Step Drug Screen Test, K020771.
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Acon Laboratories, Inc. ACON One Step Propoxyphene Test Device and Test Strip, K040445
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Description of the device:
TABLE 4
Assay Principle: Immunochromatograph assay for Cannabinoids and Propoxyphene Urine Test using a lateral flow, one step system for the qualitative detection of 11-nor-Δ9-THC-9-COOH and d-propoxyphene (target analyte) 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 IqG polyclonal antibody in membrane.
- Intended use of the device:
Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test are intended for the qualitative determination of 11-nor-A9-THC-9-COOH and d-propoxyphene (target analyte) at the specific cut-off concentration in human urine. For in vitro diagnostic use only. Wondfo Propoxyphene Urine Test is only intended for prescription use. Wondfo Cannabinoids Urine Test is intended for over-the-counter and prescription use.
1
- Comparison to the predicate device
A summary comparison of features of the Wondfo Cannabinoids Urine Test and the Wondfo Propoxyphene Urine Test and the predicate devices is provided in the Table 1 & Table 2.
Table 1: Features Comparison of the Wondfo Cannabinoids Urine Test and the Predicate Device
| Item | Device | Predicate - K020771 |
|---|---|---|
| Indication(s) for | ||
| Use | For the qualitative determination of | |
| Cannabinoids in human urine. | Same | |
| Calibrator | 11-nor-Δ9-THC-9-COOH | Same |
| 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 | |
| Specimen Type | Human Urine | Same |
| Cut Off Values | 50 ng/mL | Same |
| Configurations | Cup, Dip Card | Card, Card with |
| Integrated Cup | ||
| Intended Use | OTC Use & Prescription Use | Prescription Use |
Table 2: Features Comparison of the Wondfo Propoxyphene Urine Test and the Predicate Device
| ltem | Device | Predicate - K040445 |
|---|---|---|
| Indication(s) for | ||
| Use | For the qualitative determination of | |
| d-Propoxyphene in human urine. | Same | |
| Calibrator | d-propoxyphene | Same |
| 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 | |
| Specimen Type | Human Urine | Same |
| Cut Off Values | 300 ng/ml | Same |
| Configurations | Cup, Dip Card | Strip, device |
| Intended Use | Prescription Use | Same |
The Wondfo Cannabinoids Urine Test and Wondfo Propoxyphene Urine Test have similar technological characteristics and performance to the predicates. They are equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the text "Food and Drug Administration". The text is in a simple, sans-serif font and is left-aligned. The words are stacked on top of each other, with "Food and Drug" on the first line and "Administration" on the second line.
10903 New Hampshire Avenue Silver Spring, MD 20993
Guangzhou Wondfo Biotech Co., Ltd c/o Joe Shia c/o LSI International Inc. 504 East Diamond Ave. Suite F Gaithersburg, MD 20877
JUL 25 2012
K121557 Re:
Trade Name: Wondfo Cannabinoids Urine Test Wondfo Propoxyphene Urine Test Regulation Number: 21 CFR §862.3870 Regulation Name: Cannabinoid Test System Regulatory Class: Class II Product Codes: LDJ, JXN Dated: June 26, 2012 Received: July 16, 2012
Dear Mr Shia:
We have reviewed your Section 510(k) premarket notification of intent to market the device we forenced 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 interstate conments, or to devices that have been reclassified in accordance with the provisions of Amentalions, or to act roos man man metic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions on 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 (1 Mry, it may be such as Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. your device can be loand in Title Bey 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 modified in any Federal statutes and regulations administered by other Federal agencies. of the riot of arry I outer that Act's requirements, including, but not limited to: registration 1 ou intest comps " 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 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/Medical
Devices/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 Four thay 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,
V. K. Jain, Ph.D.
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known): K121557
Device Name: Wondfo Propoxyphene Urine Test
Indications for Use:
Wondfo Propoxyphene Urine Test is an immunochromatographic assay for the qualitative determination of d-Propoxyphene in human urine at a cutoff concentration of 300 ng/mL. The test is available in a dip card format and a cup format. This product is only intended for prescription 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_ (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 Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121557
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Indications for Use Form
510(k) Number (if known): K121557
Device Name: Wondfo Cannabinoids Urine Test
Indications for Use:
Wondfo Cannabinoids Urine Test is an immunochromatographic assay for the qualitative determination of 11-nor-A9-THC-9-COOH (major metabolite of Cannabinoids) in human urine at a cutoff concentration of 50 ng/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 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 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)
Signature
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121337
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