510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220085Substantially Equivalent

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit

Kronus, Inc., Star ID / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K220085 is the FDA 510(k) clearance record for KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit, a class II device, cleared for Kronus, Inc. on under FDA product code OIF (Tyrosine Phosphatase (Ia-2) Autoantibody Assay). FDA's definition for product code OIF reads: "The device is used for the semi-quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes)". FDA records list 9 510(k) clearances for Kronus, Inc., from to . As of , FDA records show no recalls naming K220085.

Clearance record

Decision date
Received
(590 days to decision)
Product code
OIF Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Applicant
Kronus, Inc. 170 S. Seneca Springs Way, Star ID
510(k) summary
Statement
Third party review
No

Clearances, product code OIF

Trailing 12 months

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

FDA records show no clearances under product code OIF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OIF, 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