510(k) · Cleared
ClearedQuantimetrix Nicosure Cotinine Urine Control
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quantimetrix Corp. · LAS Drug Specific Control Materials
Cleared on Oct 30, 2006 after a 32-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 30, 2006
- Review
- 32 days
- Class
- Class I
- Product code
- LAS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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 LAS? 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
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 LAS devicesLAS Drug Specific Control Materials: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LAS
1in 2009
2026 to Oct 25, outlined.
Median 510(k) review, days · LAS
Too few LAS 510(k)s in any year since 2007 to give a median.
Recalls per year · LAS
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LAS
No MAUDE report names LAS since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 1 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Quantimetrix Corp. NiCosure Cotinine Urine Control is intended as a means of monitoring
the performance of GC/MS and other drugs of Cotinine methods used for detecting the Cotinine
levels in unknown urine specimens.
Use of quality control materials is an integral part of diagnostic procedures. Daily monitoring of
control values establishes intralaboratory parameters for accuracy and precision of the test
method.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K062942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062942: Quantimetrix Nicosure Cotinine Urine Control.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062942
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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