# K021688: Nicalert

- Pathway: 510(k) (Traditional)
- Applicant: Nymox Pharmaceutical Corporation
- Decided: Oct 18, 2002 after 149 days
- Product code: MRS (Test System, Nicotine, Cotinine, Metabolites)
- Device class: 1
- Regulation: 21 CFR 862.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
NicAlertTM is intended for in vitro diagnostic professional use for the semi-quantitative detection 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 NicAlertTM 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 NicAlertTM Positive and Negative Controls are intended for in vitro diagnostic use for the quality control of the NicAlertTM test.

Source page: https://510kreport.com/device/K021688
Methodology: https://510kreport.com/methodology