FDA product code OYG: St2 Assay

OYG is the FDA product code for st2 assay. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel. FDA has cleared 1 510(k) submission under OYG. The average 510(k) review took 198 days (median 198). FDA has posted 1 recall for OYG devices.

Definition

Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma.

Classification

Top OYG applicants

Most recent OYG clearances

Recalls for OYG devices

1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-02-28.

Frequently asked questions

What is FDA product code OYG?

OYG is the FDA product code for st2 assay. It is a Class II device, regulated under 21 CFR 862.1117 and reviewed by the Clinical Chemistry panel.

What device class is OYG?

Class II, regulation 21 CFR 862.1117. Typical premarket route: 510(k).

How long does a 510(k) take for product code OYG?

Across 1 cleared submissions the average was 198 days from receipt to decision (median 198).

Which companies have the most OYG clearances?

Critical Care Diagnostics, Inc. (Dba Critical Diag (1).

Have OYG devices been recalled?

Yes: 1 product recalls across 1 recall events; the most recent began 2012-02-28.

Next steps

• Run an FDA pathway report with predicate devices for product code OYG
• Run a recall and safety report across every OYG manufacturer
• Watch product code OYG for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

All Clinical Chemistry product codes · FDA product code lookup