Cleared Traditional

K911866 - TRACE TOTAL/DIRECT BILIRUBIN REAGENT

K911866 is the FDA 510(k) clearance for TRACE TOTAL/DIRECT BILIRUBIN REAGENT by Trace Scientific , Ltd.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K911866 · Trace Scientific , Ltd. · Chemistry device
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Jul 1991
Decision
82d
Days
Class 2
Risk

K911866 is an FDA 510(k) clearance for the TRACE TOTAL/DIRECT BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Trace Scientific , Ltd. (Clayton, Vic 3168, AU). The FDA issued a Cleared decision on July 17, 1991 after a review of 82 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Trace Scientific , Ltd. devices

Submission Details

510(k) Number K911866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1991
Decision Date July 17, 1991
Days to Decision 82 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 88d · This submission: 82d
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 171
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K911866.
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
K913466 · Em Diagnostic Systems, Inc. · Oct 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc. · Oct 1991
AMERLEX-M SPECIFIC ESTROL(UNCONJUGATED) RIA KIT
K912733 · Amersham Corp. · Jul 1991
ROCHE REAGENT FOR TOTAL BILIRUBIN
K910591 · Roche Diagnostic Systems, Inc. · Apr 1991
ROCHE REAGENT FOR DIRECT BILIRUBIN
K910593 · Roche Diagnostic Systems, Inc. · Apr 1991
DIRECT BILIRUBIN REAGENT, 7776/7777/7576/7476/7176
K904468 · Amresco, Inc. · Jan 1991