Cleared Traditional

K111452 - PRESAGE ST2 ASSAY

K111452 is an FDA 510(k) clearance for PRESAGE ST2 ASSAY, manufactured by Critical Care Diagnostics, Inc. (Dba Critical Diag. The device is a Class 2 Chemistry device with product code OYG cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K111452 · Critical Care Diagnostics, Inc. (Dba Critical Diag · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
198d
Days
Class 2
Risk

K111452 is an FDA 510(k) clearance for the PRESAGE ST2 ASSAY. Classified as St2 Assay (product code OYG), Class II - Special Controls.

Submitted by Critical Care Diagnostics, Inc. (Dba Critical Diag (San Diego, US). The FDA issued a Cleared decision on December 9, 2011 after a review of 198 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1117 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K111452

510(k) Number K111452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2011
Decision Date December 09, 2011
Days to Decision 198 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 88d · This submission: 198d
Pathway characteristics
Predicate-based equivalence.

OYG Device Classification - Class 2, Special Controls

Product Code OYG St2 Assay
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1117
Definition Immunoassay For The In Vitro Quantitative Determination Of Soluble St2 Protein In Human Serum And Plasma.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Chemistry devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00047437 Completed Interventional

Exercise Training Program to Improve Clinical Outcomes in Individuals With Congestive Heart Failure

Heart Failure: A Controlled Trial Investigating Outcomes of Exercise Training (HF-ACTION)

2331
Patients (actual)
80
Sites
Prevention
Purpose
Open label
Masking
Condition studied Cardiovascular Diseases; Heart Diseases; Heart Failure, Congestive
Study design Parallel
Eligibility All sexes · 18 Years+
Principal investigator Christopher M. O'Connor
Sponsor Duke University
Started 2003-04-01 → Primary completion 2008-07-01
Primary outcome
Composite of all-cause mortality and all-cause hospitalization rates (measured at Year 3)
Secondary outcome
Changes in peak VO2
Study completed - no results published. This trial concluded in 2008 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov
K111452 · PRESAGE ST2 ASSAY
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