# K030286: Triage Cardio Profiler/Triage Cardiac Panel

- Pathway: 510(k) (Special)
- Applicant: Biosite Incorporated
- Decided: Feb 21, 2003 after 24 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 3 (2 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K973126 (1997). 2 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973126: Triage Cardiac Panel, Triage Troponin-I, Triage CK-MB, Triage Myoglobin, Triage Troponin-I and CK-MB, Triage Troponin-I, Biosite Incorporated (1997) Summary page 1.
- K021317: Triage B-Type Natriuretic Peptide (BNP) Test, Biosite Incorporated (2002)

## Most influential descendants
- K093758: BGM Galectin -3 (2010), 2 descendants of its own
- K140436: ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS (2014), 0 descendants of its own
- K111452: Presage ST2 Assay (2011), 0 descendants of its own

## Recalls of this device
- May 25, 2023 · Class I · Z-1974-2023: Raw material issue may cause cardiac panel products to have an average of 30% troponin signal reduction across measurement range 0.05 ng/mL to 30 ng/mL, QC testing won't detect anomaly, so an alternat
- May 22, 2012 · Class I · Z-1929-2012: Certain lots of the affected products may have significantly decreased precision relative to the package insert, which could result in an increased frequency of false positive or false negative result
- Apr 27, 2009 · Not classified · Z-1391-2009: The recall was initiated because the use of the affected lot may lead to reporting falsely low values for troponin I and myoglobin, possibly resulting in missed or incorrect diagnosis.

## Indications for use
The Triage@ Cardio ProfilER is a fluorescence immunoassay to be used with the Triage@Meter for the quantitative determination of Creatine Kinase MB, myoglobin, troponin I, and B-type natriuretic peptide in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury), the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure), and the risk stratification of patients with acute coronary syndromes. The Triage03 Cardiac Panel is a fluorescence immunoassay to be used with the Triage@Meter for the quantitative determination of Creatine Kinase MB, myoglobin and troponin I in EDTA whole blood and plasma specimens. The test is used as an aid in the diagnosis of myocardial infarction (injury).

Source page: https://510kreport.com/device/K030286
Methodology: https://510kreport.com/methodology