(68 days)
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No
The description details a simple immunochromatographic assay, which is a chemical test, and there is no mention of AI or ML in the provided text.
No.
The device is a test kit designed for the qualitative detection of THC and its metabolites in urine, which is a diagnostic function, not a therapeutic one.
Yes
This device is a diagnostic device because it is an immunochromatographic assay for the rapid, qualitative detection of tetrahydrocannabinol and its metabolites in urine, which is used to identify the presence of a substance in a biological sample.
No
The device description clearly states it is an "immunochromatographic assay," which is a physical test kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "rapid, qualitative detection of tetrahydrocannabinol and its metabolites... in urine". This involves testing a sample taken from the body (urine) in vitro (outside the body) to provide diagnostic information (presence of THC).
- Device Description: The description confirms it's an "immunochromatographic assay" which is a common method used in IVD tests.
- Sample Type: It uses urine, which is a biological sample tested in vitro.
- Care Setting: It's for "professional and laboratory use only," which is typical for many IVD devices.
The core function of the device is to analyze a biological sample in vitro to detect a substance, which directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.
Product codes
LDJ
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
professional and laboratory use
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three flowing lines extending upwards, possibly representing growth or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 1 8 1998
Kuo Ching Yee, Ph.D. President AmeriTek, Inc. 7030 35th Avenue, NE Seattle, Washington 98115
Re: K983188
Trade Name: dBest Tetrahydrocannabinol Test Kit Regulatory Class: II Product Code: LDJ Dated: September 10, 1998 Received: September 11, 1998
Dear Dr. Yee:
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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Sutman
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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510 (K) Number (if known): K983188
Device Name: dBest Tetrahydrocannabinol Test Kits
Indications For Use:
dBest Tetrahydrocannabinol Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of tetrahydrocannabinol and its metabolites 11-nor- 9to: rapio, quantabinol-9-carboxylic acid in urine with cutoff of 50 ng/ml. The dBest tetrahydrocannabinol Test Kit are for professional and laboratory use only.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number R2983158
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDED)
Prescription Use
OR
Over-The -Counter Use (Optional Format 1-2-96)