Cleared Traditional

K920653 - IL TEST BILIRUBIN TOTAL/DIRECT

K920653 is the FDA 510(k) clearance for IL TEST BILIRUBIN TOTAL/DIRECT by Instrumentation Laboratory CO. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K920653 · Instrumentation Laboratory CO · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
162d
Days
Class 2
Risk

K920653 is an FDA 510(k) clearance for the IL TEST BILIRUBIN TOTAL/DIRECT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 162 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 K920653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1992
Decision Date July 23, 1992
Days to Decision 162 days
Submission Type Traditional
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
74d slower than avg
Panel avg: 88d · This submission: 162d
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 137
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K920653.
SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000
K922856 · Em Diagnostic Systems, Inc. · Sep 1992
TOTAL BILIRUBIN CATALOG NO. 65407
K923083 · Em Diagnostic Systems, Inc. · Sep 1992
OLYMPUS DIRECT BILIRUBIN REAGENT
K923608 · Olympus Corp. · Aug 1992
KODAK EKTACHEM DT SLIDES (NBIL)
K921844 · Eastman Kodak Company · Jul 1992
DIAZO COLORIMETRY, BILIRUBIN
K914873 · Pointe Scientific, Inc., · Dec 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc. · Oct 1991