MICRO-PLATE COTININE EIA

K974234 · OraSure Technologies, Inc. · MKU · May 14, 1998 · Clinical Toxicology

Device Facts

• Record ID: K974234
• Device Name: MICRO-PLATE COTININE EIA
• Applicant: OraSure Technologies, Inc.
• Product Code: MKU · Clinical Toxicology
• Decision Date: May 14, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3220
• Device Class: Class 1

Indications for Use

The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Device Story

The STC Cotinine Micro-Plate EIA is an in vitro diagnostic assay designed for the qualitative and semi-quantitative detection of cotinine, a nicotine metabolite, in oral fluid samples. The device utilizes the EpiScreen™ Oral Specimen Collection Device for sample acquisition. The assay is performed in a micro-plate format, likely employing enzyme immunoassay (EIA) technology to measure cotinine levels. It is intended for use by laboratory professionals in clinical settings. The output provides clinicians with information regarding recent nicotine exposure or tobacco use, aiding in clinical decision-making related to smoking cessation programs or health assessments. The device benefits patients by providing a non-invasive method for monitoring tobacco use.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Micro-plate enzyme immunoassay (EIA) for the detection of cotinine in oral fluid. Designed for use with the EpiScreen™ Oral Specimen Collection Device. In vitro diagnostic device.

Indications for Use

Indicated for the qualitative and semi-quantitative determination of cotinine in oral fluid collected via the EpiScreen™ Oral Specimen Collection Device for in vitro diagnostic use.

Regulatory Classification

Identification

A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 4 1998

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

Re : K974234 STC Cotinine Micro-Plate EIA Regulatory Class: II Product Code: MKU Dated: April 9, 1998 Received: April 10, 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 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 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 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 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 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 Cotinine Micro-Plate EIA

Indications For Use: The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

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

**Prescription Use**
(Per 21 CFR 801.109)

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OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)

Division of Clinical Laborator 510(k) Number

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