Cleared Traditional

DIAZO COLORIMENTRY DIRECT BILIRUBIN (K904381) - FDA 510(k) Clearance

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

K904381 · Amresco, Inc. · Chemistry device
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Oct 1990
Decision
16d
Days
Class 2
Risk

K904381 is an FDA 510(k) clearance for the DIAZO COLORIMENTRY DIRECT BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Amresco, Inc. (Solon, US). The FDA issued a Cleared decision on October 12, 1990 after a review of 16 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 Amresco, Inc. devices

Submission Details

510(k) Number K904381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1990
Decision Date October 12, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 88d · This submission: 16d
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 68
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K904381.
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
K913307 · Em Diagnostic Systems, Inc. · Oct 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
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
K902801 · Beckman Instruments, Inc. · Jul 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · Em Diagnostic Systems, Inc. · Jun 1990
OLYMPUS(TM) TOTAL BILIRUBIN
K897174 · Em Diagnostic Systems, Inc. · May 1990