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

Tyrosine Phosphatase (Ia-2) Autoantibody Assay

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

OIF is the FDA product code for Tyrosine Phosphatase (Ia-2) Autoantibody Assay, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code 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)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OIF
Device name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
FDA definition
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).
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code OIF

By decision year
3 clearances under product code OIF with a decision year between 2008 and 2023, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OIF by decision year
YearClearances
20081
20181
20231

Applicants with the most clearances

Product code OIF
Applicants holding the most 510(k) clearances under product code OIF
ApplicantClearances
Kronus, Inc.2
Kronus Market Development Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code