ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)

K991443 · Roche Diagnostics Corp. · JXM · Jun 22, 1999 · Clinical Toxicology

Device Facts

• Record ID: K991443
• Device Name: ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
• Applicant: Roche Diagnostics Corp.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Jun 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The cassette COBAS Integra Serum Benzodiazepines contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of Benzodiazepines and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose.

Device Story

In vitro diagnostic reagent system for use on COBAS INTEGRA analyzer; detects benzodiazepines and metabolites in human serum, heparinized plasma, or urine. Used in clinical laboratories for toxicological screening; assists healthcare providers in managing benzodiazepine use or overdose. Provides qualitative or semi-quantitative results to support clinical decision-making regarding patient drug exposure.

Clinical Evidence

No clinical data provided; substantial equivalence based on analytical performance characteristics typical of in vitro diagnostic reagent systems.

Technological Characteristics

In vitro diagnostic reagent system; cassette-based; designed for use on the COBAS INTEGRA analyzer platform. Utilizes chemical assay principles for benzodiazepine detection in serum, plasma, or urine.

Indications for Use

Indicated for the detection of benzodiazepines and their metabolites in human serum, heparinized plasma, or urine for toxicological screening in the management of benzodiazepine use or overdose.

Regulatory Classification

Identification

A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A benzodiazepine 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 and Human Services. The logo consists of a stylized depiction of a human figure, represented by three curved lines that suggest a head, body, and legs. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the figure.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 2 1999

Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road PO Box 50457 Indianapolis, Indiana 46250-0457

Re: K991443

> Trade Name: Roche COBAS INTEGRA Serum Benzodiazepines (SBENZ) Regulatory Class: II Product Code: JXM Dated: April 23, 1999 Received: April 26, 1999

Dear Ms. Gerard:

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 Regulations, 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 (OS) 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 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.

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

## Page 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 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 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/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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}------------------------------------------------

## Indications for Use Statement

:

| 510(k) Number (if known): | K 991443 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Roche COBAS INTEGRA Serum Benzodiazepines |
| Indications for Use: | The cassette COBAS Integra Serum Benzodiazepines contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the detection of Benzodiazepines and their metabolites in human serum, heparinized plasma or urine. This reagent system is intended for use in toxicological screenings where the analytical result is used in the management of benzodiazepine use or overdose. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---------------------------------------|----|----------------------|
|---------------------------------------|----|----------------------|

(Optional format 1-2-96)

Jean Cooper

(Division Sign-Off)

Division of Clinical Laboratory, vice

510(k) Number K991443