Cleared Traditional

K050423 - OMNI MODULAR

K050423 is the FDA 510(k) clearance for OMNI MODULAR by Roche Diagnostics. It is a Class 2 Chemistry device (product code CHL) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K050423 · Roche Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
63d
Days
Class 2
Risk

K050423 is an FDA 510(k) clearance for the OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE). Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 22, 2005 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - 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.

View all Roche Diagnostics devices

Submission Details

510(k) Number K050423 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2005
Decision Date April 22, 2005
Days to Decision 63 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
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

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