(316 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 are no mentions of AI, ML, image processing, or data sets for training/testing.
No.
This device is an in vitro diagnostic test used for the qualitative detection of drugs of abuse in urine, providing preliminary results for diagnostic purposes rather than therapeutic intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above." and "For in vitro diagnostic use."
No
The device description clearly states it is an "Immunochromatographic assay" using a "lateral flow, one step system" with "monoclonal antibody-dye congugate" and "fixed drug-protein conjugate and anti-mouse IgG polyclonal antibody in membrane." This describes a physical, in vitro diagnostic test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use."
- Purpose: The device is used for the qualitative determination of drugs of abuse in urine, which is a biological sample. This analysis is performed in vitro (outside of the living body).
- Clinical Application: The measurements obtained are used in the "diagnosis and treatment of use or overdose of the drugs listed above." This directly relates to clinical decision-making based on the test results.
- Intended User: The device is intended for "healthcare professionals," who are the typical users of IVD devices in a clinical setting.
N/A
Intended Use / Indications for Use
The One Step Multiple Drugs of Abuse Assays is intended for the qualitative determination of drugs and their metabolisms In human urine. They are intended for the healthcare professional use including professionals at point-of-care sites. One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine: Amphetamine (amphetamine) Cutoff 1000ng/ml, Barbiturate (secobarbital) Cutoff 300ng/ml, Benzodiazipines (oxazepam) Cutoff 300ng/ml, Cocaine (benzoylecgonine) Cutoff 300ng/ml, Methamphetamine (methamphetamine) Cutoff 1000ng/ml, Morphine (morphine) Cutoff 300ng/ml, Opiate (morphine) Cutoff 2000ng/ml, Methadone (methadone) Cutoff 300ng/ml, Methylenedioxymethamphetamine (methylenedioxymethamphetamine) Cutoff 500ng/ml, Phencyclidine (phencyclidine) Cutoff 25ng/ml, Tricyclic antidepressant drugs (nortriptyline) Cutoff 1000ng/ml, Cannabinoids (tetrahydrocannabinol-COOH) Cutoff 50ng/ml. The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above. 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 spectroscopy (GC/MS) is the recommended confirmatory method.
Product codes (comma separated list FDA assigned to the subject device)
DKZ, DIS, JXM, DIO, LAF, DJG, DJR, LFG, LCM, DJC, LDJ, DPK
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 IgG 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 professional use including professionals at point-of-care sites.
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
§ 862.3150 Barbiturate test system.
(a)
Identification. A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.(b)
Classification. Class II (special controls). A barbiturate 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 - Wondfo Biotech Co. Ltd.
TAB 4
Submitter's name:
Address:
"""
Phone:
Name of contact person:
Name of the device:
Trade or proprietary name:
Common or usual name:
Date the summary was prepared:
SUMMARY
Guangzhou Wondfo Biotech Co., Ltd.
South China University of Technology Guangzhou, P.R. China 510641 012-86-20-871-12194
Howard Mann Sherbo Associates 8903 Spruce Mill Drive Yardley, PA 19067 Phone: (215) 369-3785 Fax: (215) 369-5246
September 16, 2004 One Step Multiple Drugs of Abuse Assays One Step Multiple Drugs of Abuse Assays Immunochromatographic test for the qualitative detection of:
- Amphetamine Barbiturate Benzodiazepine Cocaine Marijuana Methadone Methamphetamine Methylenedioxymethamphetamine Morphine Opiate Phencyclidine Tricyclic antidepressant drugs
Classification: All are Class If medical devices with the following various product codes with Code of Federal Regulation references:
| Product Code | CFR # |
|---|---|
| DKZ | 862.3100 |
| DIS | 862.3150 |
| JXM | 862.3170 |
| DIO | 862.3250 |
| LAF | 862.3610 |
| DJG | 862.3610 |
| DJG | 862.3650 |
| DJR | 862.3620 |
| LFG | 862.3650 |
| LCM | No regulation number for PCP |
| DJC | 862.3910 |
| LDJ | 862.3870 |
1
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: 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 IgG polyclonal antibody in membrane.
Intended use of the device:
The One Step Multiple Drugs of Abuse Assays is intended for the qualitative determination of drugs and their metabolisms In human urine. They are intended for the healthcare professional use including professionals at point-of-care sites.
Summary of the technological characteristics of our device compared to the predicate device:
The Wondfo Biotech Co., Ltd. One Step Multiple Drugs of Abuse Assays have similar technological characteristics and performance to the predicate and are equivalent.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 7 2005
Wondfo Biotech Co. Ltd. c/o Mr. Howard Mann Sherbo Associates 8903 Spruce Mill Drive Yardley, PA 19067
K050024 Re:
Trade/Device Name: Multiple Drugs of Abuse Assays Regulation Number: 21 CFR 862.3100 Regulation Name: Amphetamine test system Regulatory Class: Class II Product Code: DKZ, DIS, JXM, LDJ, DIO, DJR, DJC, DPK, DJG, LCM, LFG Dated: October 2, 2005 Received: October 5, 2005
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 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Patt 820).
3
Page 2 -
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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Alberto
Alberto Gutierrez, 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
510(k) Number (if known): K050024
Device Name: Multiple Drugs of Abuse Assays
Indications For Use:
One Step Multiple Drugs of Abuse Assays is used for the qualitative determination of the following drugs of abuse in urine:
| Product Name | Cutoff |
|---|---|
| Amphetamine (amphetamine) | 1000ng/ml |
| Barbiturate (secobarbital) | 300ng/ml |
| Benzodiazipines (oxazepam) | 300ng/ml |
| Cocaine (benzoylecgonine) | 300ng/ml |
| Methamphetamine (methamphetamine) | 1000ng/ml |
| Morphine (morphine) | 300ng/ml |
| Opiate (morphine) | 2000ng/ml |
| Methadone (methadone) | 300ng/ml |
| Methylenedioxymethamphetamine (methylenedioxymethamphetamine) | 500ng/ml |
| Phencyclidine (phencyclidine) | 25ng/ml |
| Tricyclic antidepressant drugs (nortriptyline) | 1000ng/ml |
| Cannabinoids (tetrahydrocannabinol-COOH) | 50ng/ml |
The configurations of the One Step Multiple Drugs of Abuse Assays are available in any combination of the above tests. These devices are intended to be used by healthcare professionals only. For in vitro diagnostic use. Measurements obtained by this device are used in the diagnosis and treatment of use or overdose of the drugs listed above.
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 spectroscopy (GC/MS) is the recommended confirmatory method.
| Prescription Use X
| (Part 21 CFR 801 Subpart D) | AND/OR | Over-The-Counter Use | (21 CFR 807 Subpart C) | |
|---|---|---|---|---|
| ----------------------------------------------------- | -- | -------- | ---------------------- | ------------------------ |
Kacy Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
510(k) K050024
page 1 of 2
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Conqurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Terry Phillips
Sign-Off
Vie of In Vitro Distgroup of Device ruation and Sal.
Page Lof 2_
) KOSO024