St2 Assay
The ST2 Assay is a clinical chemistry in vitro diagnostic device providing an immunoassay for the quantitative determination of soluble ST2 protein in human serum and plasma, which is a biomarker associated with heart failure severity and cardiac fibrosis. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OYG, with regulation number 862.1117 under the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- OYG
- Device Class
- FDA class 2
- Regulation Number
- 862.1117
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
Definition
Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K111452 | PRESAGE ST2 ASSAY | Dec 09, 2011 | Substantially Equivalent | Critical Care Diagnostics, Inc. (Dba Critical Diag |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.