510(k) · Cleared

Cleared

Nicalert

K021688510(k) TraditionalCleared Oct 18, 2002149-day reviewClass I21 CFR 862.3220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Nymox Pharmaceutical Corporation · MRS Test System, Nicotine, Cotinine, Metabolites

Cleared on Oct 18, 2002 after a 149-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided: Oct 18, 2002
Review: 149 days
Class: Class I
Product code: MRS
Recalls: None
Predicates: 0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K021688Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in MRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MRS devices

MRS Test System, Nicotine, Cotinine, Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRS

FDA has decided no MRS device since 2007.

Median 510(k) review, days · MRS

Too few MRS 510(k)s in any year since 2007 to give a median.

Recalls per year · MRS

No recall names MRS since 2007.

Adverse event reports per year · MRS

1in 2019

2007high 1 (2019) · low 0 (2007)2025

MAUDE reports naming product code MRS, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	1
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K021688 · printed Nov 5, 2026

Cite this page

510(k) Report. “K021688: Nicalert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021688

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026