# K974461: Triage Cardiac Controls, Triage Troponin-I Control, Triage CK-MB Control, Triage Myoglobin Control

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Dec 10, 1997 after 15 days
- Product code: JJT (Enzyme Controls (Assayed And Unassayed))
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K030089: Triage Cardiac Controls; Triage Cardio Profiler 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

Source page: https://510kreport.com/device/K974461
Methodology: https://510kreport.com/methodology