(41 days)
The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/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 FDA premarket notification (510k) provides marketing authorization for a device and therefore does not contain acceptance criteria or study data.
To clarify, 510(k)s demonstrate substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. This typically involves performance data compared to the predicate, but not necessarily a formal study with acceptance criteria in the same way a de novo or PMA submission would require.
Therefore, I am unable to provide the requested information based on the provided document.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG - 6 1997
Ms. Janis Freestone · Director, Regulatory Affairs BIONIKE Incorporated 1015 Grandview Drive - ------So. San Francisco, CA 94080
Re : K972384 Bionike AQ™ One Step Cocaine Test Regulatory Class: II Product Code: DIO Dated: June 17, 1997 Received: June 26, 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 Regulations, Title 21, Parts 800 to 895. ਖ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 320) 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 action. In addition, FDA may publish further announcements 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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510k Number:_
Device Name: Bionike AQ™ One Step Cocaine Test
Indications for Use:
The Bionike One Step Cocaine Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of benzoylecgonine at a cutoff concentration of 300ng/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.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. 972384
Spiescuption
presenption use
38
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).