(26 days)
Not Found
Not Found
No
The summary describes a standard in vitro diagnostic test for drug screening in urine and contains no mention of AI or ML technology.
No.
The device is an in vitro diagnostic test used for the identification of drugs in urine, which helps in the diagnosis and treatment of drug abuse, but it is not a therapeutic device itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "An in vitro diagnostic test" and that "Measurements obtained by this device are used in the diagnosis and treatment of drug abuse."
No
The device description clearly indicates it is an "in vitro diagnostic test" for analyzing urine, which inherently involves physical components for sample collection and analysis, not just software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states that it is an "in vitro diagnostic test" and that the measurements are used in the "diagnosis and treatment of drug abuse." This directly aligns with the definition of an IVD, which are tests performed on samples taken from the human body (like urine in this case) to provide information for the diagnosis, treatment, or prevention of disease or other conditions.
- Device Description: The name "QuickScreen™ Pro Multi Drug Screening Test" further supports its function as a diagnostic test.
The other sections being "Not Found" do not negate its classification as an IVD based on the clear statement in the Intended Use.
N/A
Intended Use / Indications for Use
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.
Product codes
DKZ, DIO, LAF, DJG, LDJ, LCM
Device Description
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or fabric. The overall design is simple and recognizable.
APR - 1 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tuan Pham President Phamatech, Inc. 9265 Activity Road, #112/113 San Dieqo, California 92126
Re : K980865 QuickScreen™ Pro Multi Drug Screening Test Requlatory Class: II Product Code: DKZ, DIO, LAF, DJG, LDJ, LCM February 28, 1998 Dated: Received: March 6, 1998
Dear Mr. Pham:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Fax:6196355843
INDICATIONS FOR USE
Applicant: Phamatech
510 (k) Number (if known): 980865
Device Name: QuickScreen™ Pro Multi Drug Screening Test
Indications for Use:
An in vitro diagnostic test for the qualitative identification of amphetamine, cocaine, methamphetamine, opiates, PCP and THC in urine. Measurements obtained by this device are used in the diagnosis and treatment of drug abuse.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of the CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laborate 510(k) Number.
Division Sign-off Division of Clinical Laboratory Devices 510 (k) Number:
Prescription Use:
Per 21 CFR 801.109
OR
Over the Counter: