(37 days)
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.
Not Found
This is a 510(k) clearance letter for a device from 1997, and as such, it does not contain the detailed information about acceptance criteria and study design that would be present in a modern regulatory submission for AI/ML devices. The letter primarily confirms substantial equivalence to a predicate device.
Therefore, many of the requested details cannot be extracted from the provided text. However, based on the information available, here's what can be provided and what cannot:
1. A table of acceptance criteria and the reported device performance
The provided document (a 510(k) clearance letter) does not contain a table of acceptance criteria or specific reported device performance metrics. It states that the device 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 clearance letter confirms the device's substantial equivalence to a predicate device, implying that its performance is considered acceptable relative to that predicate. For detailed performance, one would typically need to refer to the original 510(k) submission, which is not provided here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided document. For drug screening tests like this, the "ground truth" would typically be established by a reference method such as GC/MS rather than expert consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document. This type of adjudication is more relevant for subjective interpretations (e.g., image reading) rather than a qualitative chemical assay.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) study is not applicable to this device. This device is an in vitro diagnostic test (a chemical assay) and does not involve human readers interpreting AI outputs.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This device is a standalone diagnostic test. It's a "rapid immunochromatographic competitive assay." This means it provides a result directly from a sample without an "algorithm" in the modern AI sense or a human-in-the-loop interpretation of AI output. Its performance would inherently be "standalone."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a cannabinoid screen, as indicated by the statement "The test is qualitative and provides only a preliminary analytical result which must be confirmed using GC/MS," would be GC/MS (Gas Chromatography-Mass Spectrometry). GC/MS is the gold standard for confirming drug presence and concentration in toxicology.
8. The sample size for the training set
This information is not available in the provided document. For a traditional immunochromatographic assay, there isn't a "training set" in the sense of machine learning. The development involves analytical studies to establish performance characteristics, which would use samples, but not for "training" an AI model.
9. How the ground truth for the training set was established
Not applicable as there is no "training set" in the AI/ML sense for this type of device. The accuracy of such a device is established through comparison with a reference method, typically GC/MS, for both development and validation.
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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 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
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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
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AST ANDRESS
Bionike AQ Cannabinoid 510(k)
§ 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).