# K093032: Triage Total 3 Controls and Calibration Verification Set

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Nov 13, 2009 after 45 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K974827 (1998). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072892: Triage Total Controls 5, Triage Total Calibration Verification 5, Biosite Incorporated (2007) Summary page 1.

## Indications for use
The Triage® Total 3 Controls are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance. The Triage® Total 3 Calibration Verification Set are assayed materials to be used with the Triage® Troponin I Test, Triage® BNP Test, Triage® Cardio2 Panel and Triage® Cardio3 Panel devices and the Triage® Meter to assist the end user in monitoring product performance.

Source page: https://510kreport.com/device/K093032
Methodology: https://510kreport.com/methodology