(37 days)
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There are no Reference Device(s) K/DEN numbers mentioned in the text.
No
The summary describes a rapid immunochromatographic assay, which is a chemical test, and there is no mention of AI or ML in the provided text.
No
Explanation: This device is a diagnostic test used to screen for cannabinoids and their metabolites in human urine. It provides a preliminary analytical result, not a therapeutic intervention or treatment.
Yes
The device screens human urine for the presence of Cannabinoids and its metabolites, which is a diagnostic purpose to identify specific substances in the body.
No
The device description is not found, but the intended use clearly describes a "rapid immunochromatographic competitive assay," which is a physical test kit, not software.
Yes, based on the provided information, the Bionike AQ™ One Step Cannabinoids Test is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The description explicitly states it is used to "screen human urine for the presence of Cannabinoids and its metabolites." This involves testing a sample taken from the body (in vitro) to gain information about a person's health status (in this case, the presence of certain substances).
- Sample Type: It uses "human urine," which is a biological sample tested outside of the body.
- Purpose: The purpose is to provide a "preliminary analytical result" for the presence of a substance in the sample, which is a core function of IVDs.
The fact that it's for "use by health care professionals only" and provides a "qualitative" result that needs confirmation doesn't negate its classification as an IVD. These are characteristics of many IVD devices.
N/A
Intended Use / Indications for Use
The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals 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
human urine
Indicated Patient Age Range
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Intended User / Care Setting
health care professionals only.
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)
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Reference Device(s)
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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).
0
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 an abstract symbol resembling an eagle or a stylized human figure with outstretched arms.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 25 1997
Janis Freestone Director, Requlatory Affairs Bionike, Inc. 1015 Grandview Drive So. San Francisco, California 94080-4910
Re : K971841 Bionike AQ™ Cannabinoid (THC) Test Regulatory Class: II Product Code: LDJ Dated: May 16, 1997 Received: May 19, 1997
Dear Ms. Freestone:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 (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 Radioloqical Health
Enclosure
2
INDICATION FOR USE STATEMENT.
Intended Use Statement
510k Number:
Device Name: Bionike AQ™ One Step Cannabinoids(THC) Test
Indications for Use:
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The Bionike AQ™ One Step Cannabinoids Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of Cannabinoids and its metabolites at a cutoff concentration of 50ng/mL. The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS. The test is for use by health care professionals only.
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(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 6971841
Class ( 1 ( 1 ) ( 1 ) ( 1 ) ( 1 ) ( 1 ) ( ) ( ) ) ( ) ( ) ( ) ) ( ) ( ) ( ) ( ) ) ( ) ( ) ( ) ) ( ) ( ) ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( )
_ over-the-counter
AST ANDRESS
Bionike AQ Cannabinoid 510(k)