Cleared Traditional

ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions

K253491 · Roche Diagnostics · Chemistry

Feb 2026

Decision

111d

Days

Class 2

Risk

About This 510(k) Submission

K253491 is an FDA 510(k) clearance for the ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), 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 862.1600.

Submission Details

510(k) Number	K253491 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