# K060788: Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jul 10, 2006 after 109 days
- Product code: DIF (Drug Mixture Control Materials)
- Device class: 1
- Regulation: 21 CFR 862.3280
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K903430 (1990). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050037: Triage Tox Drug Screen Controls, Biosite Incorporated (2005) Summary page 1.

## Recalls of this device
- Apr 9, 2019 · Class II · Z-1552-2020: Due to an error in the programming of the Control CODE CHIP module for this lot, a failing result is inappropriately displayed for AMP and mAMP. This issue results in the Triage Meter displaying a fai
- Sep 23, 2013 · Class III · Z-0053-2014: Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail whe

## Indications for use
The Triatge TOX Drug Screen Controls are to be used with the Triage TOX Screen tests and Triage Meters to assist the laboratory in monitoring test perlbrmance.

Source page: https://510kreport.com/device/K060788
Methodology: https://510kreport.com/methodology