VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

K981314 · Sun Biomedical Laboratories, Inc. · DJR · Sep 4, 1998 · Clinical Toxicology

Device Facts

• Record ID: K981314
• Device Name: VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE
• Applicant: Sun Biomedical Laboratories, Inc.
• Product Code: DJR · Clinical Toxicology
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3620
• Device Class: Class 2

Intended Use

Qualitative visual test for the presence of Methadone and its metabolites in urine samples.

Device Story

Visualine II (SunLine) Methadone is an in vitro diagnostic test for qualitative detection of Methadone and its metabolites in urine. Device utilizes visual immunoassay technology to identify presence of drug analytes in patient samples. Intended for use in clinical laboratory settings to assist in drug screening. Healthcare professionals interpret visual results to determine presence of Methadone. Provides rapid screening capability to support clinical decision-making regarding substance use monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Qualitative visual immunoassay for urine drug screening. Form factor is a test device for manual interpretation. No specific materials, connectivity, or software algorithms described.

Indications for Use

Indicated for the qualitative detection of Methadone and its metabolites in human urine samples.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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_