Cleared Traditional

Glucose HK Gen.3 (K253490) - FDA 510(k) Clearance

Also marketed or referenced as:
ONLINE DAT Methadone II cobas pro integrated solutions

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

K253490 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
111d
Days
Class 2
Risk

K253490 is an FDA 510(k) clearance for the Glucose HK Gen.3. Classified as Hexokinase, Glucose (product code CFR), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on February 12, 2026 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Roche Diagnostics devices

Submission Details

510(k) Number K253490 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2025
Decision Date February 12, 2026
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.

Regulatory Peers - CFR Hexokinase, Glucose

All 144
Devices cleared under the same product code (CFR) and FDA review panel - the closest regulatory comparables to K253490.
Glucose2
K252357 · Abbott Ireland · Oct 2025
cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH
K220134 · Roche Diagnostics · Sep 2022
Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
K191899 · Roche Diagnostics · Aug 2019
ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM
K170316 · Abbott Laboratories · Oct 2017
UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH)
K131189 · Beckman Coulter, Inc. · Apr 2014
GLUCOSE HK NEW FORMULATION TEST SYSTEM
K062239 · Roche Diagnostics Corp. · Sep 2006