# K040459: Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jul 6, 2004 after 134 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: 2 generations back to K974827 (1998). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030088: Triage Cardiac Calibration Verification Controls, Triage Cardio Profiler Calibration Verficication Controls, Biosite Incorporated (2003) Summary page 1.
- K030089: Triage Cardiac Controls; Triage Cardio Profiler Controls, Biosite Incorporated (2003) Summary page 1.

## Most influential descendants
- 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® Profiler S.O.B. (Shortness of Breath) Calibration Verification Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to verify the calibration of the Triage® Profiler S.O.B. Panel throughout the measurable range. The Triage® Profiler S.O.B. (Shortness of Breath) Controls are to be used with the Triage® Profiler S.O.B. Panel and Triage® Meter Plus to assist the laboratory in monitoring test performance.

Source page: https://510kreport.com/device/K040459
Methodology: https://510kreport.com/methodology