# K050037: Triage Tox Drug Screen Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Mar 22, 2005 after 74 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: 3 generations back to K903430 (1990). 5 ancestors in all.
1 later device descends 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)
- K012999: Triage Tox Drug Screen Controls, Catalog #94001, Biosite Incorporated (2001) Summary page 1.
- 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
- 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 Triage TOX Drug Screen Controls are to be used with the Triage TOX Drug Screen tests and Triage MeterPlus to assist the laboratory in monitoring test performance.

Source page: https://510kreport.com/device/K050037
Methodology: https://510kreport.com/methodology