# K013002: Triage Tox Drug Screen Calibration Verification Controls, Catalog #94002

- 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.

## Cited in the summary but kept off the family tree
- K835230: Dade Behring Emit Calibrators/Controls. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Indications for use
The Triage® TOX Drug Screen Calibration Verification Controls are to be used with the Triage® TOX Drug Screen and Triage® Meter to verify the calibration of the Triage™ TOX Drug Screen throughout the reportable range.

Source page: https://510kreport.com/device/K013002
Methodology: https://510kreport.com/methodology