# K060417: Modification to Quantimetrix Urine Drugs of Abuse Control

- Pathway: 510(k) (Special)
- Applicant: Quantimetrix Corp.
- Decided: Mar 21, 2006 after 32 days
- Product code: DIF (Drug Mixture 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. The FDA summary names no predicate by number.

## Indications for use
The Quantimetrix Corp. Drug of Abuse Urine Screen Control is intended to be used as a means of monitoring the performance of Abuscreen ONLINE, AxSYM, Triage and other drugs of abuse screening methods used for detecting drugs in unknown urine specimens.

Source page: https://510kreport.com/device/K060417
Methodology: https://510kreport.com/methodology