AUTO-LYTE BARBITURATES EIA

K982745 · OraSure Technologies, Inc. · DIS · Nov 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982745
• Device Name: AUTO-LYTE BARBITURATES EIA
• Applicant: OraSure Technologies, Inc.
• Product Code: DIS · Clinical Toxicology
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3150
• Device Class: Class 2

Intended Use

The STC AUTO-LYTE® Barbiturates EIA is intended for use in the qualitative determination of barbiturates in urine. This test is intended for in vitro diagnostic use.

Device Story

STC AUTO-LYTE® Barbiturates EIA is an in vitro diagnostic assay for qualitative detection of barbiturates in urine samples. Operates via Enzyme Immunoassay (EIA) technology; designed for clinical laboratory use. Provides qualitative results to healthcare providers to assist in identifying barbiturate presence. Facilitates clinical decision-making regarding drug screening or toxicology assessment.

Clinical Evidence

No clinical data provided; device clearance based on substantial equivalence to existing legally marketed devices.

Technological Characteristics

Enzyme Immunoassay (EIA) for qualitative urine analysis. In vitro diagnostic reagent system.

Indications for Use

Indicated for the qualitative determination of barbiturates in human urine for in vitro diagnostic use.

Regulatory Classification

Identification

A barbiturate test system is a device intended to measure barbiturates, a class of hypnotic and sedative drugs, in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

Special Controls

*Classification.* Class II (special controls). A barbiturate 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 8 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K982745 STC AUTO-LYTE® Barbiturates EIA Trade Name: Requlatory Class: II Product Code: DIS Dated: August 3, 1998 Received: August 6, 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 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 (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 requlatory 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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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, "Misbrandinq by reference to premarket notification"(21 CFR 807.97). Other qeneral 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® Barbiturates EIA

Indications For Use: The STC AUTO-LYTE® Barbiturates EIA is intended for use in the qualitative determination of barbiturates in urine. This test is intended for in vitro diagnostic use.

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) (Division Sign-Off) Division of Clinical Laboretory Dey.
S10(k) Number c\\fda\indica.doc 510(k) Number