# K030088: Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 17, 2003 after 7 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: 1 generation back to K974827 (1998). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974827: Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R) Myoglobin Calibration Verification Controls, Triage, Biosite Incorporated (1998) Summary page 1.
- K000231: Triage BNP Calibration Verification Controls, Biosite Incorporated (2000)

## Most influential descendants
- K040459: Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls (2004), 2 descendants of its own
- K072892: Triage Total Controls 5, Triage Total Calibration Verification 5 (2007), 1 descendant of its own
- K093032: Triage Total 3 Controls and Calibration Verification Set (2009), 0 descendants of its own

## Indications for use
The Triage@Cardio ProfilER / Triage@Cardiac Calibration Verification Controls are to be used with the Triage@Cardio ProfilER / Triage@Cardiac Panel and Triage@Meter to verify the calibration of the Triage@Cardio ProfilER / Triage@Cardiac Panel throughout the measurable range.

Source page: https://510kreport.com/device/K030088
Methodology: https://510kreport.com/methodology