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510(k) K220085

KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit by Kronus, Inc. — Product Code OIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 24, 2023
Date Received
January 11, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tyrosine Phosphatase (Ia-2) Autoantibody Assay
Device Class
Class II
Regulation Number
866.5660
Review Panel
IM
Submission Type

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).

Other clearances by Kronus, Inc.

  • K180607 — Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit (November 23, 2018)
  • K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (January 19, 2018)
  • K161951 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (July 22, 2016)
  • DEN150030 — KRONUS Aquaporin-4 Autoantibody (AQP4Ab) ELISA Assay (April 25, 2016)
  • K915429 — KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT (March 30, 1992)
  • K915428 — KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT (March 30, 1992)
  • K894364 — MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) (July 25, 1989)
  • K894203 — ANTI-THYROGLOBULIN TEST KIT (July 25, 1989)

Other clearances for product code OIF

  • K171731 — KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit (January 19, 2018)
  • K073590 — KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT (April 10, 2008)