(29 days)
Not Found
No
The device description and intended use clearly describe a lateral flow immunochromatographic assay, which is a chemical-based test. There is no mention of any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The process is described as a two-step process where preliminary results from the lateral flow test are followed by laboratory confirmation if needed.
No
The device is described as an immunochromatographic assay for qualitative and simultaneous detection of various drugs in human urine, providing preliminary test results for diagnostic purposes, not for treatment.
Yes
The device is described as an "immunochromatographic assay for qualitative and simultaneous detection" of various substances in human urine, which directly indicates its use for qualitative testing and detection of medical conditions or statuses, a function characteristic of a diagnostic device.
No
The device description clearly indicates it is a lateral flow immunochromatographic assay, which is a physical test strip/cup, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "qualitative and simultaneous detection of [various drugs] in human urine." This is a diagnostic purpose, analyzing a biological sample (urine) to detect the presence of specific substances.
- Device Description: The description details the mechanism of the test ("immunochromatographic assays," "lateral flow, competitive binding system") which is a common method used in IVD devices for analyzing biological samples.
- Sample Type: The device analyzes "human urine samples," which is a biological specimen.
- Regulatory Information: The mention of "Prescription Use (Part 21 CFR 801 Subpart D); Over-The-Counter Use (21 CFR 801 Subpart C)" indicates that this device is subject to FDA regulations for medical devices, including IVDs.
- Performance Studies: The summary of performance studies, including analytical performance and interference studies, are typical requirements for demonstrating the validity and reliability of an IVD device.
- Predicate Devices: The listing of predicate devices with K numbers (FDA premarket notification numbers) further confirms that this device is being compared to other legally marketed IVD devices.
All of these factors align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Secobarbital | 300 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Phencyclidine | 25 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methadone | 300 ng/mL |
| Notriptyline | 1000ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup 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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic 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.
Product codes
DJG, LFG, LCM, DKZ, DIS, JXM, LDJ, DIO, LAF, DJR
Device Description
The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
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
Not Found
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)
The test strips of the candidate device are the same as those cleared with the predicate devices. Drug cutoffs of the candidate device are also identical to the predicate devices. Analytical performance was established for each device in the submissions as stated below. In addition, verification studies were conducted in support of the modification to have a multi-drug test cup (that detects 2 to 13 drugs at the same time), including interference studies and a lay-user study.
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.
K141532, K140089, K142044, K142609, K143535, K150179, K150602
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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is composed of three intertwined figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 1, 2015
GUANGZHOU WONDFO BIOTECH CO., LTD. C/O JOE SHIA BUSINESS DIRECTOR 504 EAST DIAMOND AVE. SUITE F GAITHERSBURG MD 20877
Re: K151478
Trade/Device Name: Wondfo CR3 Keyless Split Sample Cup Regulation Number: 21 CFR 862.3650 Regulation Name: Opiate test system Regulatory Class: II Product Code: DJG, LFG, LCM, DKZ, DIS, JXM, LDJ, DIO, LAF, DJR Dated: May 26, 2015 Received: June 2, 2015
Dear Mr. Joe 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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,
Katherine Serrano -S
For :
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
2
Indications for Use
510(k) Number (if known) K151478
Device Name
Wondfo CR3 Keyless Split Sample Cup
Indications for Use (Describe)
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
| Drug(Identifier) | Cut-off level |
|---|---|
| Amphetamine | 1000 ng/mL |
| Secobarbital | 300 ng/mL |
| Oxazepam | 300 ng/mL |
| Cocaine | 300 ng/mL |
| Cannabinoids | 50 ng/mL |
| Methamphetamine | 1000 ng/mL |
| Methylenedioxymethamphetamine | 500 ng/mL |
| Morphine | 300 ng/mL or 2000 ng/mL |
| Phencyclidine | 25 ng/mL |
| Oxycodone | 100 ng/mL |
| Buprenorphine | 10 ng/mL |
| Methadone | 300 ng/mL |
| Notriptyline | 1000ng/mL |
Configuration of the Wondfo CR3 Keyless Split Sample Cup 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 or LC/MS is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine. Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic 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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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SUMMARY
| 1. Date the summary was prepared: | June 29, 2015 |
|---|---|
| 2. Submitter's name: | |
| Address: | Guangzhou Wondfo Biotech Co., Ltd. |
| South China University of Technology | |
| Guangzhou, P.R. China 510641 | |
| Phone: 012-86-20-32296069 | |
| 3. Name of contact person: | Joe Shia |
| LSI International Inc. 504 East Diamond Ave. | |
| Suite F Gaithersburg, MD 20877 | |
| Telephone: 240-505-7880 | |
| Fax: 301-916-6213 | |
| 4. Name of the device: |
-
- Name of the device
| Common or usual name: | Multi-Drug Urine Test Cup |
|---|---|
| Trade or proprietary name: | Wondfo CR3 Keyless Split Sample Cup |
-
- Classification: All are Class II medical devices with the following various product codes with Code of Federal
| Product Code | Classification | Regulation Section | Panel |
|---|---|---|---|
| DKZ | II | 21 CFR § 862.3100, Amphetamine Test System | Toxicology (91) |
| LDJ | II | 21 CFR § 862.3870, Cannabinoids Test System | Toxicology (91) |
| DIO | II | 21 CFR § 862.3250, Cocaine and Cocaine Metabolites Test System | Toxicology (91) |
| LAF | II | 21 CFR § 862.3610, Methamphetamine Test System | Toxicology (91) |
| DJG | II | 21 CFR § 862.3650, Opiate test system | Toxicology (91) |
| JXM | II | 21 CFR § 862.3170, Benzodiazepine Test System | Toxicology (91) |
| LCM | unclassified | Enzyme Immunoassay Phencyclidine | Toxicology (91) |
| DIS | II | 21 CFR § 862.3150, Barbiturate Test System | Toxicology (91) |
| DJR | II | 21 CFR § 862.3620, Methadone Test System | Toxicology (91) |
| LFG | II | 21 CFR § 862.3910, Tricyclic antidepressant drug Test System | Toxicology (91) |
-
- Description of the device:
5
The Wondfo CR3 Keyless Split Sample Cup uses immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in human urine samples. The test is a lateral flow, competitive binding system. The test is the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.
-
- Test Principle
The Wondfo CR3 Keyless Split Sample Cup is a rapid test for the qualitative detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone Buprenorphine, Methadone and Notriptyline in urine samples and contains lateral flow chromatographic immunoassays for these analytes. Each assay uses a mouse monoclonal anti-drug antibody-dye conjugate, fixed drug-protein conjugates, and anti-mouse IgG polyclonal antibodies coated on the test membranes. When the absorbent end of the test is immersed into a urine sample, the urine is absorbed into the device by capillary action and mixes with the antibody-dye conjugate, flowing across the pre-coated membrane. At analyte concentrations below the target cut-off, antibody-dye conjugates bind to the drug-protein conjugate immobilized in the Test Region (T) of the device. This produces a colored test line that indicates a negative result. When analyte concentration is above the cut-off, analyte molecules bind to the antibody-dye conjugate, preventing the antibody-dye conjugate from binding to the drug-protein conjugate immobilized in the Test Region (T) of the device. No colored band shows in the test region, indicating a potentially positive result. A band should form in the control region (C) of the device regardless of the presence of drug or metabolite in the sample.
- Test Principle
-
- Intended use of the device:
The Wondfo CR3 Keyless Split Sample Cup is a competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Secobarbital, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Phencyclidine, Oxycodone, Buprenorphine, Methadone and Notriptyline in human urine at the cutoff concentrations of:
- Intended use of the device:
| 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 2000 ng/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 CR3 Keyless Split Sample Cup can consist of any combination of the
6
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 is the preferred confirmatory method.
The test will yield preliminary positive results when prescription drugs Buprenorphine, Oxazepam, Oxycodone and Secobarbital are ingested, even at or above therapeutic 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.
-
- Comparison to the predicate device
The Wondfo CR3 Keyless Split Sample Cup is a modified product format derived from the previously FDA-cleared Wondfo CR3 Keyless dual drug of abuse tests. A summary comparison of features of the Wondfo CR3 Keyless Split Sample Cup and the predicate devices is provided in the following Table.
- Comparison to the predicate device
| Item | New Devices | Predicate devices
(K141532, K140089,
K142044, K142609,
K143535, K150179,
K150602) |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| 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 Notriptyline
(TCA) in human urine. | 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 |
| Results | Qualitative | Same |
7
| Specimen Type | Human urine | Same |
|---|---|---|
| Cut Off Values | Amphetamine (AMP): 1,000 ng/ml, Secobarbital(BAR): 300 ng/ml, Oxazepam (BZO):300 ng/ml, Cocaine(COC): 300 ng/ml, Cannabinoids (THC):50 ng/ml, Methamphetamine (MET): 1,000 ng/ml, Methylenedioxymethamphetamine (MDMA): 500 ng/ml, Morphine (MOP): 300 ng/ml 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 | Same |
| Configurations | Cup, can detect from 2 to 13 drugs | Cup, each test can only detect up to 2 drugs |
| Intended Use | OTC Use & Prescription Use | Same |
10. Performance Characteristics
The test strips of the candidate device are the same as those cleared with the predicate devices. Drug cutoffs of the candidate device are also identical to the predicate devices. Analytical performance was established for each device in the submissions as stated below. In addition, verification studies were conducted in support of the modification to have a multi-drug test cup (that detects 2 to 13 drugs at the same time), including interference studies and a lay-user study.
| Drug(Identifier) | 510(K) # |
|---|---|
| Amphetamine(AMP) | K141532 |
| Secobarbital (BAR) | K143535 |
| Oxazepam (BZO) | K140089 |
| Cocaine (COC) | K141532 |
| Cannabinoids (THC) | K150179 |
| Methamphetamine (MET) | K150602 |
| Methylenedioxymethamphetamine | |
| (MDMA) | K142044 |
| Morphine (MOP) | K150602 |
| Morphine 2000 (OPI) | K140089 |
| Phencyclidine (PCP) | K142044 |
| Oxycodone (OXY) | K150179 |
| Buprenorphine (BUP) | K142609 |
| Methadone (MTD) | K143535 |
8
| Notriptyline (TCA) | K142609 |
|---|
11. Conclusion
Based on the test principle and acceptable performance characteristics, it's concluded that the Wondfo CR3 Keyless Split Sample Cup is substantially equivalent to the predicates.