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Presage ST2 Assay

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K111452

by Critical Care Diagnostics, Inc. (Dba Critical Diag

Identifiers

510(k) Number
K111452 FDA 510(k)
FDA Product Code
OYG FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1117 FDA 510(k)
Regulation Number
862.1117 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Presage ST2 Assay is an in vitro diagnostic device classified under Clinical Chemistry nomenclature. It is designed to quantitatively measure ST2, a biomarker associated with cardiac stress and myocardial injury, aiding in the assessment of acute coronary syndrome and heart failure risk stratification.

This assay is intended for use in clinical laboratories and is supplied as a single-use reagent kit. It requires validation for use with specific immunoassay platforms and is regulated under FDA 510(k) clearance (K111452) and the Medical Device Directive (MDD). Sterility and performance are ensured through manufacturer-controlled processes, with compliance verified through regulatory submissions.

Frequently asked questions

What clinical scenarios is the Presage ST2 Assay primarily used to evaluate in patients?

The Presage ST2 Assay is designed to quantitatively measure ST2, a biomarker linked to cardiac stress and myocardial injury. Clinicians use it to help assess acute coronary syndrome and to stratify the risk of heart failure in patients, particularly in settings where rapid diagnostic insights are critical.

How is the Presage ST2 Assay supplied, and is it intended for single-use or repeated testing?

The Presage ST2 Assay is supplied as a single-use reagent kit, meaning each kit is intended for one test run. This ensures sterility and performance consistency, as it is manufactured and validated under controlled processes for in vitro diagnostic use in clinical laboratories.

Does this assay require compatibility with specific laboratory equipment, and if so, what should buyers confirm before purchasing?

Yes, the Presage ST2 Assay requires validation for use with specific immunoassay platforms. Buyers should confirm compatibility with their laboratory’s existing equipment and workflows before implementation to ensure accurate and reliable results.

How is sterility and performance of the Presage ST2 Assay maintained, and what regulatory compliance does it adhere to?

Sterility and performance are maintained through manufacturer-controlled processes, with compliance verified through regulatory submissions. The assay holds FDA 510(k) clearance (K111452) and adheres to the Medical Device Directive (MDD), ensuring it meets stringent quality and safety standards for in vitro diagnostic use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Critical Care Diagnostics, Inc. (Dba Critical Diag

Sources (2)

  • FDA 510(k) K111452 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 19, 2026