510(k) · Cleared
Recalled · Class III · 2012Presage ST2 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Critical Care Diagnostics, Inc. (Dba Critical Diag · OYG St2 Assay
Cleared on Dec 9, 2011 as substantially equivalent to K093758 (Bg Medicine, Inc., 2010) after a 198-day review. Its family tree reaches back 6 generations to 2000. 2 of the 14 devices in its family, counting itself, have a Class I recall. It has been recalled once.
- Decided
- Dec 9, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- OYG
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN000010 (2000). 13 ancestors in all, the oldest K973126 (1997). No later device cites it as a predicate yet. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backDEN000010 Triage B-Type Natriuretic Peptide (BNP) TestBiosite Incorporated · 2000
- 5 generations backK022516 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2002
- 4 generations backK032646 Elecsys Probnp ImmunoassayRoche Diagnostics Corp. · 2003
- 3 generations backK051787 Triage BNP Test, Model 98000XRBiosite Incorporated · 2005
- 2 generations backK052789 Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200Biosite Incorporated · 2006 · Recalled
- 1 generation backK093758 BGM Galectin -3Bg Medicine, Inc. · 2010
- This deviceK111452 Presage ST2 AssayCritical Care Diagnostics, Inc. (Dba Critical Diag · 2011
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN000010 | Triage B-Type Natriuretic Peptide (BNP) Test | Biosite Incorporated | 2000 | — |
| −5 | K022516 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2002 | — |
| −4 | K032646 | Elecsys Probnp Immunoassay | Roche Diagnostics Corp. | 2003 | — |
| −3 | K051787 | Triage BNP Test, Model 98000XR | Biosite Incorporated | 2005 | — |
| −2 | K052789 | Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 | Biosite Incorporated | 2006 | 1 |
| −1 | K093758 | BGM Galectin -3 | Bg Medicine, Inc. | 2010 | — |
| 0 (this device) | K111452 | Presage ST2 Assay | Critical Care Diagnostics, Inc. (Dba Critical Diag | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 1 |
| 2004 | 1 | 0 |
| 2008 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K093758 | BGM Galectin -3Summary page 1…arketed devices to which we are claiming equivalence [807.92(a)(3)]: 510 (k) Trade or Proprietary or Model Name Mnfcue Number k093758 Galectin-3 Assay BG-Medicinc Indication for Use: The Critical Diagnostics Presag… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 28, 2012 | Class III | Z-2012-2012 | Component design/selection | 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. |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K080269Triage Cardioprofiler and Profiler S.O.B. PanelsBiosite Incorporated · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K030286Triage Cardio Profiler/Triage Cardiac PanelBiosite Incorporated · 2003 · 2 generations back · ◆ in the 2003 ancestors bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 11 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 13 ancestors have a recall of any class; 2 have a Class I recall.
- 1 other device also cites its predicate K093758.
How does its category compare?
All OYG devicesOYG St2 Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OYG
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · OYG
Too few OYG 510(k)s in any year since 2007 to give a median.
Recalls per year · OYG
No recall names OYG since 2007.
Adverse event reports per year · OYG
No MAUDE report names OYG since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111452 · printed Nov 4, 2026
Cite this page
510(k) Report. “K111452: Presage ST2 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K111452
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026