Cleared Traditional

Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions

K253490 · Roche Diagnostics · Chemistry
Feb 2026
Decision
111d
Days
Class 2
Risk

About This 510(k) Submission

K253490 is an FDA 510(k) clearance for the Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions, a Hexokinase, Glucose (Class II — Special Controls, product code CFR), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on February 12, 2026, 111 days after receiving the submission on October 24, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1345.

Submission Details

510(k) Number K253490 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code CFR — Hexokinase, Glucose
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1345

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