Cleared Traditional

GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO (K093623) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K093623 · Instrumentation Laboratory CO · Chemistry device
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Jun 2010
Decision
207d
Days
Class 2
Risk

K093623 is an FDA 510(k) clearance for the GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 .... Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on June 18, 2010 after a review of 207 days - an extended review cycle.

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.

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Submission Details

510(k) Number K093623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2009
Decision Date June 18, 2010
Days to Decision 207 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
119d slower than avg
Panel avg: 88d · This submission: 207d
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 234
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K093623.
Atellica CH Diazo Total Bilirubin (D_TBil)
K251998 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Atellica® CH Diazo Direct Bilirubin (D_DBil)
K223078 · Siemens Healthcare Diagnostics, Inc. · Jun 2023
Atellica® CH Diazo Total Bilirubin (D_TBil)
K222104 · Siemens Healthcare Diagnostics, Inc. · Mar 2023
Total Bilirubin2
K223324 · Abbott Ireland Diagnostics Division · Dec 2022
VITROS XT Chemistry Products TBIL-ALKP Slides
K190807 · Ortho-Clinical Diagnostics, Inc. · Apr 2019
Total Bilirubin
K150510 · Abbott Laboratories · Apr 2015