Cleared Traditional

K905622 - COULTER DIRECT BILLRUBIN REAGENT

K905622 is the FDA 510(k) clearance for COULTER DIRECT BILLRUBIN REAGENT by Coulter Electronics, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K905622 · Coulter Electronics, Inc. · Chemistry device
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Dec 1990
Decision
12d
Days
Class 2
Risk

K905622 is an FDA 510(k) clearance for the COULTER DIRECT BILLRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on December 26, 1990 after a review of 12 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 Coulter Electronics, Inc. devices

Submission Details

510(k) Number K905622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1990
Decision Date December 26, 1990
Days to Decision 12 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 88d · This submission: 12d
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 168
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K905622.
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
DIAZO COLORIMENTRY DIRECT BILIRUBIN
K904381 · Amresco, Inc. · Oct 1990
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · Synermed, Inc. · Sep 1990
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
K902801 · Beckman Instruments, Inc. · Jul 1990