AQ OPIATES (MORPHINE) TEST

K971361 · Bionike Laboratories, Inc. · DJG · Jun 6, 1997 · Clinical Toxicology

Device Facts

• Record ID: K971361
• Device Name: AQ OPIATES (MORPHINE) TEST
• Applicant: Bionike Laboratories, Inc.
• Product Code: DJG · Clinical Toxicology
• Decision Date: Jun 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3650
• Device Class: Class 2

Intended Use

The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites 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.

Device Story

Rapid immunochromatographic competitive assay for human urine screening; detects morphine and metabolites at 300ng/mL cutoff. Used by healthcare professionals in clinical settings. Provides preliminary qualitative results; requires GC/MS confirmation for definitive diagnosis. Benefits patient by enabling rapid initial assessment of opiate presence.

Clinical Evidence

No clinical data provided.

Technological Characteristics

Rapid immunochromatographic competitive assay; qualitative; urine-based; 300ng/mL cutoff.

Indications for Use

Indicated for healthcare professionals to screen human urine for morphine and its metabolites at a 300ng/mL cutoff concentration. Provides preliminary qualitative results requiring GC/MS confirmation.

Regulatory Classification

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.

Special Controls

*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).

Submission Summary (Full Text)

{0}------------------------------------------------

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" arranged around the perimeter. Inside the circle is a stylized symbol featuring three human profiles forming a shape resembling a bird in flight.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN - 6 1997

Janis Freestone Director, Regulatory Affairs Bionike, Inc. 1015 Grandview Drive So. San Francisco, California 94080-4910

Re: K971361 Bionike AQ™ Opiates (morphine) Test Requlatory Class: II Product Code: DJG Dated: April 10, 1997 Received: April 11, 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, 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 reqistration, listing of devices, good manufacturing practice, labelinq, 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 requlations.

{1}------------------------------------------------

Paqe 2

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 leqally 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 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 [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

{2}------------------------------------------------

510k Number:__________________________________________________________________________________________________________________________________________________________________

Device Name: Bionike One Step Opiate (Morphine) Test

Indications for Use:

The Bionike One Step Opiate(Morphine) Test is a rapid immunochromatographic competitive assay used to screen human urine for the presence of morphine and its metabolites 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.

K971361
(Division
Division of Clinical Laboratory Devices
510(k) Number
K971361