Cleared Special

K100853 - COBAS 8000 MODULAR SERIES ANALYZER

K100853 is an FDA 510(k) clearance for COBAS 8000 MODULAR SERIES ANALYZER, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with 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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100853

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.

DCF Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (DCF) and FDA review panel - the closest regulatory comparables to K100853.
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K100853 · COBAS 8000 MODULAR SERIES ANALYZER
Download PDF FDA Summary Roche Diagnostics Cor…