Cleared Traditional

K111143 - POLY-CHEM 90 TOTAL BILIRUBIN

K111143 is the FDA 510(k) clearance for POLY-CHEM 90 TOTAL BILIRUBIN by Polymedco, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K111143 · Polymedco, Inc. · Chemistry device
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Sep 2011
Decision
132d
Days
Class 2
Risk

K111143 is an FDA 510(k) clearance for the POLY-CHEM 90 TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on September 1, 2011 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 Polymedco, Inc. devices

Submission Details

510(k) Number K111143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 2011
Decision Date September 01, 2011
Days to Decision 132 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
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 148
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K111143.
EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENT
K123802 · Medica Corp. · Mar 2013
COBAS INTEGRA BILIRUBIN DIRECT GEN.2
K123965 · Roche Diagnostics · Feb 2013
ARCHITECT TOTAL BILIRUBIN
K121985 · Abbott Laboratories · Feb 2013
GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO
K093623 · Instrumentation Laboratory CO · Jun 2010
EASY RA D BIL REAGENT MODEL 10212, EASY RA GLU-H REAGENT MODEL 10200
K091991 · Medica Corp. · Sep 2009
COBAS INTEGRA 400/800 BILIRUBIN TOTAL
K081193 · Roche Diagnostics · Jan 2009