# K974827: Triage (R) Cardiac Panel Calibration Verification Controls, Triag (R) Myoglobin Calibration Verification Controls, Triage

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jan 8, 1998 after 15 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
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K030088: Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls (2003), 3 descendants of its own
- 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® Cardiac Calibration Verification Controls are controls used to assess the daily performance of the Triage® Cardiac Panel. These controls contain Myoglobin, Creatine Kinase MB and Troponin-I at three concentrations.

Source page: https://510kreport.com/device/K974827
Methodology: https://510kreport.com/methodology