(36 days)
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No
The description details a standard immunochromatographic test, which relies on chemical reactions and visual interpretation, not AI/ML. There are no mentions of AI, ML, or related concepts.
No
The device is a diagnostic tool for detecting drugs in urine, not a device used for treating a disease or condition.
Yes
The device rapidly detects specific substances in human urine, which is a form of diagnostic testing to identify the presence of certain drugs.
No
The device description clearly states it is an "immunochromatographic test," which is a physical test strip or kit, not a software-only product.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- It analyzes a human specimen: The text explicitly states it detects substances "in human urine."
- It is used for diagnostic purposes: While it provides a "preliminary analytical test result," its purpose is to detect the presence of specific drugs of abuse, which is a diagnostic activity.
- It is intended for use in a healthcare setting: The intended use specifies "hospitals, physician offices, health clinics and drug treatment/counseling centers," indicating a medical context.
- It is not for over-the-counter sale: This further supports its classification as a device intended for professional use in a diagnostic setting.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description.
N/A
Intended Use / Indications for Use
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:
THC - Tetrahydrocannabinol - 50 ng/mL
COC - Cocaine (Benzoylecgonine) - 300 ng/mL
OPS - Opiates (Codeine/Morphine) - 300 ng/mL
AMP - Amphetamine - 1000 ng/mL
PCP - Phencyclidine - 25 ng/mL
This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.
PROFILE-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Product codes
DKE, DIO, DJG, DKZ, LCM
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
JUL 29 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Michael Turanchik Director, Research & Development MedTox Diagnostics 1238 Anthony Road Burlington, North Carolina 27215
Re : K982211 PROFILE® -II Regulatory Class: II Product Code: DKE, DIO, DJG, DKZ, LCM Dated: June 22, 1998 Received: June 23, 1998
Dear Mr. Turanchik:
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, qood 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. ਰੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 Gutman
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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EXHIBIT III PROFILE-II 510(k) SUBMISSION
INDICATIONS FOR USE FORM
510(k) Number (if known): Jurg 22 l (
Device Name: __ PROFILE-II
Indications for Use:
PROFILE-II is a one-step immunochromatographic test for the rapid, qualitative detection of cannabinoids (THC), cocaine, opiates, amphetamines and phencyclidine (PCP) in human urine. The test detects the major metabolites of these drugs at the following cut-off concentrations:
| THC | Tetrahydrocannabinol | 50 ng/mL |
|---|---|---|
| COC | Cocaine (Benzoylecgonine) | 300 ng/mL |
| OPS | Opiates (Codeine/Morphine) | 300 ng/mL |
| AMP | Amphetamine | 1000 ng/mL |
| PCP | Phencyclidine | 25 ng/mL |
This product is intended for use under medical supervision in hospitals, physician offices, health clinics and drug treatment/counseling centers. It is not for over-the-counter sale.
PROFILE-II provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | or Over-The-Counter Use |
|---|---|
| ------------------------------------------ | ------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Device:
| 510(k) Number | |
|---|---|
| 7 |