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510(k) K252357

Glucose2 by Abbott Ireland — Product Code CFR

K252357 is an FDA 510(k) premarket notification submitted by Abbott Ireland for the device "Glucose2". The FDA issued a decision of Substantially Equivalent on October 24, 2025. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Abbott Ireland has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2025
Date Received
July 29, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hexokinase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Abbott Ireland

  • K244042 — Calcium2 (February 10, 2025)

Other clearances for product code CFR

  • K253490 — Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (February 12, 2026)
  • K220134 — cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ON (September 16, 2022)
  • K191899 — Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated s (August 16, 2019)
  • K170316 — ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM (October 19, 2017)
  • K153644 — ELITech Clinical Systems GLUCOSE HK SL, ELITech Clinical Systems ELICAL 2, ELITe (September 7, 2016)
  • K151487 — Diatron Pictus 700 Clinical Chemistry Analyzer, Diatron ISE, Diatron Glucose He (January 14, 2016)
  • K131189 — UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) (April 17, 2014)
  • K123018 — ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELEC (April 23, 2013)
  • K120681 — ADVIA CHEMISTRY GLUH_3 REAGENTS (May 15, 2012)
  • K120369 — HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) (May 10, 2012)

FDA data resources