# K012999: Triage Tox Drug Screen Controls, Catalog #94001

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Oct 3, 2001 after 27 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
Longest line of descent: 2 generations back to K903430 (1990). 4 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981590: Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con, Bio-Rad (1998) Summary page 1.
- K970666: Liquicheck Urine Toxicology Negative Control, Bio-Rad (1997) Summary page 1.
- K935230: Emit Iic Negative Control, Control I and II, Syva Co. (1994) Summary page 1.

## Most influential descendants
- K050037: Triage Tox Drug Screen Controls (2005), 1 descendant of its own
- K060788: Triage Tox Drug Screen Control Level 1 Model 94413 and Level 2 Model 94414 (2006), 0 descendants of its own

## Indications for use
The Tnage TOX Drug Screen Controls are assayed materials to be used with the Triage® TOX Drug Screen and Triage® Meter to assist the laboratory in monitoring test performance.

Source page: https://510kreport.com/device/K012999
Methodology: https://510kreport.com/methodology