Cleared Traditional

COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B (K111188) - FDA 510(k) Clearance

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

K111188 · Roche Diagnostics · Chemistry device
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May 2012
Decision
383d
Days
Class 2
Risk

K111188 is an FDA 510(k) clearance for the COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCV.... 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 May 14, 2012 after a review of 383 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K111188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2011
Decision Date May 14, 2012
Days to Decision 383 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
295d slower than avg
Panel avg: 88d · This submission: 383d
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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