Cleared Traditional

K253491 - ISE indirect K for Gen.2

Also marketed or referenced as:
ISE indirect Na for Gen.2 ISE indirect Cl for Gen.2 cobas pro integrated solutions

K253491 is an FDA 510(k) clearance for ISE indirect K for Gen.2, manufactured by Roche Diagnostics. The device is a Class 2 Chemistry device with product code CEM cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K253491 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2026
Decision
111d
Days
Class 2
Risk

K253491 is an FDA 510(k) clearance for the ISE indirect K for Gen.2. Classified as Electrode, Ion Specific, Potassium (product code CEM), 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 862.1600 - 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

FDA 510(k) Submission Details - K253491

510(k) Number K253491 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.

CEM Device Classification - Class 2, Special Controls

Product Code CEM Electrode, Ion Specific, Potassium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1600
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 - CEM Electrode, Ion Specific, Potassium

All 67
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