AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U

K982831 · OraSure Technologies, Inc. · JXM · Nov 12, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982831
• Device Name: AUTO-LYTE BENZODIAZEPINES EIA MODEL NUMBER 1210U
• Applicant: OraSure Technologies, Inc.
• Product Code: JXM · Clinical Toxicology
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3170
• Device Class: Class 2

Intended Use

The STC AUTO-LYTE® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. This test is intended for in vitro diagnostic use.

Device Story

AUTO-LYTE® Benzodiazepines EIA is an in vitro diagnostic assay for detecting benzodiazepines in human urine. Device utilizes enzyme immunoassay (EIA) technology; samples are processed in a laboratory setting by trained personnel. Output provides qualitative or semi-quantitative results to assist healthcare providers in identifying benzodiazepine presence. Results support clinical decision-making regarding drug screening or monitoring. Benefits include rapid, standardized detection of benzodiazepine compounds in clinical specimens.

Clinical Evidence

No clinical data provided in the document; regulatory clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Enzyme immunoassay (EIA) for in vitro diagnostic use. Designed for urine specimen analysis. Operates as a laboratory-based diagnostic test.

Indications for Use

Indicated for the qualitative or semi-quantitative determination of benzodiazepines in human urine for in vitro diagnostic use.

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)

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NOV 1 2 1998

R. Sam Niedbala, Ph.D., BCFE Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799

Re : K982831/S2

> AUTO-LYTE® Benzodiazepine EIA (Urine) Trade Name: Requlatory Class: II Product Code: JXM October 7, 1998 Dated: Received: October 16, 1998

Dear Dr. Niedbala:

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 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 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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 requlation (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 Butman

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ AUTO-LYTE® Benzodiazepines EIA________________________________________________________________________________________________________________________________

Indications For Use: The STC AUTO-LYTE® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. This test is intended for in vitro diagnostic use.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory vice:
510(k) Number k982831

Prescription Use
(Per 21 CFR 801.109)
✓

OR

Over-The-Counter Use ____________

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