# K111452: Presage ST2 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Critical Care Diagnostics, Inc. (Dba Critical Diag
- Decided: Dec 9, 2011 after 198 days
- Product code: OYG (St2 Assay)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to DEN000010 (2000). 13 ancestors in all.
No later device cites it as a predicate yet.
2 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093758: BGM Galectin -3, Bg Medicine, Inc. (2010) Summary page 1.

## Recalls of this device
- Feb 28, 2012 · Class III · Z-2012-2012: The recall was initiated because Critical Diagnostics has confirmed that it is possible to obtain inaccurate test results for specimens when using the Presage ST2 Assay kits.

## Indications for use
The Critical Diagnostics Presage® ST2 Assay kit is an in vitro diagnostic device that quantitatively measures ST2 in serum or plasma by enzyme-linked immunosorbant assay (ELISA) in a microtiter plate format. The Presage® ST2 Assay is indicated to be used in conjunction with clinical evaluation as an aid in assessing the prognosis of patients diagnosed with chronic heart failure. The Presage@ ST2 Assay Kit Controls, Level 1 and Level 2, are designed to be used for monitoring the performance of test procedures on the Critical Diagnostics Presage® ST2 Assay kit.

Source page: https://510kreport.com/device/K111452
Methodology: https://510kreport.com/methodology