NICALERT

K021688 · Nymox Pharmaceutical Corporation · MRS · Oct 18, 2002 · Clinical Toxicology

Device Facts

• Record ID: K021688
• Device Name: NICALERT
• Applicant: Nymox Pharmaceutical Corporation
• Product Code: MRS · Clinical Toxicology
• Decision Date: Oct 18, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3220
• Device Class: Class 1

Indications for Use

NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.

Device Story

NicAlert™ is an in vitro diagnostic test for semiquantitative determination of cotinine in urine. Used by professionals to assess tobacco exposure within the past 48 hours. Input: urine sample. Principle: immunochromatographic assay; cotinine competes for binding sites. Output: visual semiquantitative result based on 100 ng/mL cutoff. Benefits: provides objective assessment of tobacco use or exposure. Includes positive and negative controls for quality assurance.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic immunochromatographic assay for urine cotinine. Semiquantitative detection with 100 ng/mL cutoff. Includes positive and negative controls for quality control.

Indications for Use

Indicated for professional in vitro diagnostic use to detect cotinine in urine to assess tobacco exposure (cigarettes, pipes, chewing tobacco) within the past 48 hours. Cutoff: 100 ng/mL. Note: Environmental tobacco smoke may cause positive results in non-users.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of a human figure with three lines extending above it, resembling a bird in flight.

Food and Orun Administratio 2098 Gaither Road Rockville MD 20851

# CT 1 8 2002

Dr. P. Averback Nymox Corporation 230 West Passaic Street Maywood, NJ 07607

Re: k021688

> Trade/Device Name: NicAlert™ Regulation Number: 21 CFR 862.3220 Regulation Name: Carbon monoxide test system Regulatory Class: Class I Product Code: MRS; DIF Dated: September 4, 2002 Received: September 9, 2002

Dear Dr. Averback:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrl/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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#### Nymo>

#### INDICATIONS FOR USE STATEMENT 2.

### INDICATIONS FOR USE

Applicant:

510(k) Number:

Device Name: NicAlert™

Indications for Use:

NicAlert™ is intended for in vitro diagnostic professional use for the semiquantitative determination of cotinine in urine for the purpose of determining if an individual has been exposed to tobacco products such as cigarettes, pipes, or chewing tobacco within the past 48 hours. The cutoff concentration for the NicAlert™ test is 100 ng/mL. Second hand smoke exposure (environmental tobacco smoke) may cause a positive result in a non-user of tobacco products. The NicAlert™ Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlert™ test.

Sean Cogg

(r)
D y Devices
510(k) Name K021648

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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May 17, 2002 Urine Cotinine N-2002

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