Cleared Special

K100853 - COBAS 8000 MODULAR SERIES ANALYZER

K100853 is the FDA 510(k) clearance for COBAS 8000 MODULAR SERIES ANALYZER by Roche Diagnostics Corp.. It is a Class 2 Chemistry device (product code DCF) cleared through the Special 510(k) pathway after a 167-day FDA review.

K100853 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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Sep 2010
Decision
167d
Days
Class 2
Risk

K100853 is an FDA 510(k) clearance for the COBAS 8000 MODULAR SERIES ANALYZER. Classified as Albumin, Antigen, Antiserum, Control (product code DCF), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on September 9, 2010 after a review of 167 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5040 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K100853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2010
Decision Date September 09, 2010
Days to Decision 167 days
Submission Type Special
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
79d slower than avg
Panel avg: 88d · This submission: 167d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DCF Albumin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5040
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 - DCF Albumin, Antigen, Antiserum, Control

All 16
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K100853.
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K051191 · Diagnostic Chemicals , Ltd. · Jul 2005
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K042643 · Ortho-Clinical Diagnostics, Inc. · Nov 2004
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K033525 · Dade Behring, Inc. · Jan 2004