(68 days)
dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml. The dBest Opiates Test Kits are for professional and laboratory use only.
dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml.
This document is a 510(k) clearance letter from the FDA for a diagnostic device, the dBest Opiates Test Kit. It does not contain the detailed acceptance criteria or a study write-up proving the device meets those criteria.
Therefore, I cannot provide the requested information from this document. The document primarily states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not elaborate on the performance data or studies that led to this determination.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image shows a logo on the left and the date "NOV 1 8 199" on the right. The logo is a circular seal with text around the perimeter and a stylized image in the center. The date is printed in a bold, sans-serif font.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K. C. Yee, Ph.D., M.D. President AmeriTek, Inc. Diagnostic Division 7030 35th Avenue N.E. Seattle, Washington 98115
Re : K983190 Trade Name: dBest Opiates Test Kit Requlatory Class: II Product Code: DJG Dated: September 10, 1998 September 11, 1998 Received:
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 Requlations, 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 Requlation (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 requlatory 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.
{1}------------------------------------------------
Page 2
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, "Misbrandinq 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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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
{2}------------------------------------------------
Page of
510 (K) Number (if known): K 983190
Device Name: dBest Opiates Test Kits
Indications For Use:
dBest Opiates Test Kit is a simple one step immunochromatographic assay for rapid, qualitative detection of opiates and its metabolites such as codeine and heroin in urine with cutoff of 300 ng/ml. The dBest Opiates Test Kits are for professional and laboratory use only.
(Division
Division of Clinical Laboratory Services
510(k) Number K983190
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PATE IF NEEDEN)
Prescription Use
OR
Over-The -Counter Use (Optional Format 1-2-96)
. . . . . .
§ 862.3650 Opiate test system.
(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).