(147 days)
Qualitative visual test for the presence of Methadone and its metabolites in urine samples.
Visualine II (Also Known As SunLine) Methadone
I am sorry, but the provided text from the FDA 510(k) letter for the Visualine II (SunLine) Methadone device does not contain any information about acceptance criteria or a study proving that the device meets those criteria.
This document is a marketing clearance letter, which states that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to a legally marketed predicate device for the stated indications for use. It outlines regulatory classifications, general controls, and contact information for further inquiries.
To answer your request, I would need to analyze a different type of document, such as the actual 510(k) summary, a clinical study report, or a validation report, which would typically contain details about performance studies and acceptance criteria.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
3 1698 SEP
Ming Sun, Ph.D. · Sun Biomedical Laboratories, Inc. 604 VPR Center 1001 Lower Landing Road Blackwood, New Jersey 08012
Re : K981314 Visualine II (Also known as SunLine) Methadone Requlatory Class: II Product Code: DJR Dated: July 31, 1998 Received: August 5, 1998
Dear Dr. Sun:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 QS inspections, the Food and Druq Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ n/a
Device Name: Visualine II (Also Known As SunLine) Methadone
Indications For Use:
Qualitative visual test for the presence of Methadone and its metabolites in urine samples.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use in (Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
Patricia Bierlaust
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).