Cleared Special

K033009 - ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2

K033009 is an FDA 510(k) clearance for ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN..., manufactured by Roche Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CIX cleared through the Special 510(k) pathway after a 20-day FDA review.

K033009 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2003
Decision
20d
Days
Class 2
Risk

K033009 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 16, 2003 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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. Low regulatory complexity profile. 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 - K033009

510(k) Number K033009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date October 16, 2003
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

CIX Device Classification - Class 2, Special Controls

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 109
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K033009 · ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2
Download PDF FDA Summary Roche Diagnostics Cor…