Cleared Traditional

K252357 - Glucose2 (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K252357 · Abbott Ireland · Chemistry device
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Oct 2025
Decision
87d
Days
Class 2
Risk

K252357 is an FDA 510(k) clearance for the Glucose2. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Abbott Ireland (Longford, IE). The FDA issued a Cleared decision on October 24, 2025 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1345 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K252357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2025
Decision Date October 24, 2025
Days to Decision 87 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized Yes - Predetermined Change Control Plan authorized FDA has pre-authorized specific future modifications to this device, a pathway common in AI/SaMD devices.
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 88d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. PCCP authorized - AI/SaMD pathway.

Device Classification

Product Code CFR Hexokinase, Glucose
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1345
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.