# K062942: Quantimetrix Nicosure Cotinine Urine Control

- Pathway: 510(k) (Traditional)
- Applicant: Quantimetrix Corp.
- Decided: Oct 30, 2006 after 32 days
- Product code: LAS (Drug Specific Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- 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
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.

Source page: https://510kreport.com/device/K062942
Methodology: https://510kreport.com/methodology