Cleared Traditional

K082210 - TOTAL BILIRUBIN L3K

K082210 is the FDA 510(k) clearance for TOTAL BILIRUBIN L3K by Genzyme Diagnostics P.E.I., Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K082210 · Genzyme Diagnostics P.E.I., Inc. · Chemistry device
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Dec 2008
Decision
132d
Days
Class 2
Risk

K082210 is an FDA 510(k) clearance for the TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Genzyme Diagnostics P.E.I., Inc. (Charlottetown, Prin Ed Island, CA). The FDA issued a Cleared decision on December 16, 2008 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1110 - 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. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Genzyme Diagnostics P.E.I., Inc. devices

Submission Details

510(k) Number K082210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date December 16, 2008
Days to Decision 132 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 88d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIG Diazo Colorimetry, Bilirubin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1110
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 - CIG Diazo Colorimetry, Bilirubin

All 169
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K082210.
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
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K081193 · Roche Diagnostics · Jan 2009
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COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226
K063543 · Roche Diagnostics Corp. · Dec 2006
STAT PROFILE CRITICAL CARE XPRESS (CCX), MODEL 1+
K061830 · Nova Biomedical Corp. · Nov 2006