MICRO-PLATE COTININE EIA

K974534 · OraSure Technologies, Inc. · MKU · May 18, 1998 · Clinical Toxicology

Device Facts

• Record ID: K974534
• Device Name: MICRO-PLATE COTININE EIA
• Applicant: OraSure Technologies, Inc.
• Product Code: MKU · Clinical Toxicology
• Decision Date: May 18, 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 serum and plasma. For In Vitro Diagnostic Use.

Device Story

STC Cotinine Micro-Plate EIA is an in vitro diagnostic test for measuring cotinine levels in serum and plasma. The device utilizes an enzyme immunoassay (EIA) format on a micro-plate. It is intended for use by laboratory professionals in clinical settings. The assay provides qualitative or semi-quantitative results, which assist healthcare providers in assessing nicotine exposure or tobacco use status. The output is interpreted by laboratory personnel to support clinical decision-making regarding patient health and smoking cessation monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Micro-plate enzyme immunoassay (EIA) for the detection of cotinine in serum and plasma. In vitro diagnostic device.

Indications for Use

Indicated for the qualitative and semi-quantitative determination of cotinine in human serum and plasma samples 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 1 8 1998

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

K974534 Re : STC Cotinine Micro-Plate EIA (Serum and Plasma) II Regulatory Class: Product Code: MKU April 7, 1998 Dated: Received: April 20, 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, Druq, 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 reguirements 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 requlation (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 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 regulations.

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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
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 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 serum and plasma. For In Vitro Diagnostic Use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K984534

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