510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111452Substantially Equivalent

Presage St2 Assay

Critical Care Diagnostics, Inc. (dba Critical Diag, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111452 is the FDA 510(k) clearance record for PRESAGE ST2 ASSAY, a class II device, cleared for Critical Care Diagnostics, Inc. (Dba Critical Diag on under FDA product code OYG (St2 Assay). FDA's definition for product code OYG reads: "Immunoassay for the in vitro quantitative determination of soluble ST2 protein in human serum and plasma". FDA records list one 510(k) clearance for Critical Care Diagnostics, Inc. (Dba Critical Diag. As of , FDA records show one recall naming K111452.

Clearance record

Decision date
Received
(198 days to decision)
Product code
OYG St2 Assay
Regulation
21 CFR 862.1117
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Critical Care Diagnostics, Inc. (Dba Critical Diag 3030 Bunker Hill St., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OYG

Trailing 12 months

FDA records hold no clearances under product code OYG in the trailing twelve months.

FDA records show no clearances under product code OYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OYG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260