(149 days)
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No
The summary describes a simple in vitro diagnostic test for cotinine, with no mention of AI, ML, image processing, or complex algorithms typically associated with AI/ML in medical devices.
No.
The device is described as an in vitro diagnostic tool for determining cotinine levels in urine to assess tobacco exposure, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states that 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". This directly indicates its use in diagnosing or determining a health-related condition or exposure.
No
The device is described as an in vitro diagnostic test for cotinine in urine, which implies a physical test kit or strip, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that NicAlert™ is "intended for in vitro diagnostic professional use".
- Nature of the Test: The test determines the presence and semi-quantitative level of cotinine in urine, which is a biological sample. This is a characteristic of in vitro diagnostic tests.
- Purpose: The purpose is to determine if an individual has been exposed to tobacco products, which is a diagnostic purpose.
- Target User: The intended user is a "professional user," which is common for IVD devices used in clinical or laboratory settings.
Therefore, the information clearly indicates that NicAlert™ is an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MRS; DIF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
professional use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.3220 Carbon monoxide test system.
(a)
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.(b)
Classification. Class I (general controls). 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.
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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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Participation Use | |
|---|---|
| ------------------- | -- |
or
| Over-the Counter Use | |
|---|---|
| ---------------------- | -- |
May 17, 2002 Urine Cotinine N-2002
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