ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION

K972891 · Roche Diagnostic Systems, Inc. · DKZ · Oct 1, 1997 · Clinical Toxicology

Device Facts

• Record ID: K972891
• Device Name: ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION
• Applicant: Roche Diagnostic Systems, Inc.
• Product Code: DKZ · Clinical Toxicology
• Decision Date: Oct 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3100
• Device Class: Class 2

Intended Use

The Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine. Periodate may be used in conjunction with Abuscreen ONLINE for Amphetamines to minimize interference which may be caused by the presence of ßhydroxamine compounds in urine samples.

Device Story

Abuscreen ONLINE for Amphetamines is an in vitro diagnostic assay for human urine analysis; detects amphetamine, methamphetamine, and metabolites. Utilizes periodate as an optional additive to mitigate interference from ß-hydroxamine compounds. Designed for use on Olympus AU800/1000 clinical chemistry analyzers. Operated by laboratory personnel in clinical settings. Provides qualitative or semi-quantitative results to assist healthcare providers in identifying drug presence. Supports clinical decision-making regarding substance use screening.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic immunoassay; designed for use on Olympus AU800/1000 automated clinical chemistry analyzers. Employs chemical reagents for the detection of amphetamine and methamphetamine metabolites in urine. Includes optional periodate treatment for interference reduction.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of amphetamine, methamphetamine, and their metabolites in human urine. Intended for use with the Olympus AU800/1000 instrument. Optional use of periodate to reduce interference from ß-hydroxamine compounds.

Regulatory Classification

Identification

An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). An amphetamine 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

OCT - 1 1997

James W. Haynes Regulatory Affairs Associate Roche Diagnostics Systems 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771

Re : K972891 Abuscreen ONLINE for Amphetamines with Periodate Olumpus AU800/1000 Product Code: DKZ Requlatory Class: II Dated: Auqust 4, 1997 Received: August 5, 1997

Dear Mr. Haynes:

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 You may, therefore, Food, Drug, and Cosmetic Act (Act). 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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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 regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CDIA-88), Child device may require if it does, you should contact. cacegorization: 10 accessor 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 described in your 510(k) prematice of your device to a legally marketed predicate device results in a classification for your marketed produce actes 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 Villo dragnostic Geveceb, productionally, 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 Gutman

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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97289

510(k) Number (if known)

Device Name: Abuscreen ONLINE for Amphetamines with Periodate Olympus AU800/1000 Instrument Application

Indications for Use:

The Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semi-quantitative detection of amphetamine and methamphetamine and their metabolites in human urine. Periodate may be used in conjunction with Abuscreen ONLINE for Amphetamines to minimize interference which may be caused by the presence of ßhydroxamine compounds in urine samples.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K972891

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)