STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)

K982061 · OraSure Technologies, Inc. · DIO · Aug 25, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982061
• Device Name: STC COCAINE METABOLITE MICRO-PLATE EIA (ORASURE DEVICE)
• Applicant: OraSure Technologies, Inc.
• Product Code: DIO · Clinical Toxicology
• Decision Date: Aug 25, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3250
• Device Class: Class 2

Intended Use

The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Device Story

The STC Cocaine Metabolite Micro-Plate EIA is an in vitro diagnostic assay used to detect cocaine and its metabolites in oral fluid. The device utilizes the OraSure® Oral Specimen Collection Device for sample collection. It operates as an enzyme immunoassay (EIA) performed in a micro-plate format. The assay is intended for use by clinical laboratory professionals to provide qualitative results. The output assists healthcare providers in identifying the presence of cocaine metabolites in patients, supporting clinical decision-making regarding substance use. The device is used in a laboratory setting.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on the device's intended use and technological characteristics.

Technological Characteristics

Enzyme immunoassay (EIA) micro-plate format for the qualitative detection of cocaine metabolites in oral fluid. Designed for use with the OraSure® Oral Specimen Collection Device.

Indications for Use

Indicated for the qualitative detection of cocaine and cocaine metabolites in oral fluid specimens collected using the OraSure® Oral Specimen Collection Device. Intended for in vitro diagnostic use.

Regulatory Classification

Identification

A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.

Special Controls

*Classification.* Class II (special controls). A cocaine and cocaine metabolite 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).

Reference Devices

• OraSure® Oral Specimen Collection Device

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 25 1998

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

K982061 Re : STC Cocaine Metabolite Micro-Plate EIA Regulatory Class: II Product Code: DIO Dated: August 3, 1998 August 11, 1998 Received:

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 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 The general controls provisions of the Act 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 requlations 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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.

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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 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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: STC Cocaine Metabolite Micro-Plate EIA

Indications For Use: The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. For In Vitro Diagnostic Use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 1982061

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

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