# K072892: Triage Total Controls 5, Triage Total Calibration Verification 5

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Dec 7, 2007 after 58 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K974827 (1998). 7 ancestors in all.
1 later device descends 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)
- K040459: Triage Profiler S.O.B. Controls and S.O.B. Calibration Verification Controls, Biosite Incorporated (2004) Summary page 1.

## Most influential descendants
- K093032: Triage Total 3 Controls and Calibration Verification Set (2009), 0 descendants of its own

## Recalls of this device
- Jul 28, 2020 · Class II · Z-3054-2020: Product was shipped with refrigeration (ice) instead of frozen (dry ice).
- Oct 12, 2016 · Class II · Z-0588-2017: Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.
- Feb 6, 2009 · Not classified · Z-1790-2010: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
- Feb 6, 2009 · Not classified · Z-1789-2010: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.
- Feb 6, 2009 · Not classified · Z-1788-2010: Incidence of low recovery results has exceeded post market surveillance thresholds of customer complaints in the field.

## Indications for use
The Triage Total Controls 5 are assayed materials to be used with the Triage® Profiler S.O.B. TM Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to assist in monitoring test performance. The Triage Total Calibration Verification 5 materials are to be used with the Triage Profiler S.O.B. TM Panel, Triage CardioProfilER® Panel, Triage Cardiac Panel, Triage BNP Test, Triage D-Dimer Test and the Triage Meters to verify the calibration of the Test Devices throughout the measurable range.

Source page: https://510kreport.com/device/K072892
Methodology: https://510kreport.com/methodology