Cleared Traditional

K902199 - COULTER DIRECT BILIRUBIN

K902199 is the FDA 510(k) clearance for COULTER DIRECT BILIRUBIN by Coulter Corp.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K902199 · Coulter Corp. · Chemistry device
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Jun 1990
Decision
27d
Days
Class 2
Risk

K902199 is an FDA 510(k) clearance for the COULTER DIRECT BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on June 12, 1990 after a review of 27 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 Corp. devices

Submission Details

510(k) Number K902199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date June 12, 1990
Days to Decision 27 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
61d faster than avg
Panel avg: 88d · This submission: 27d
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 K902199.
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · Synermed, Inc. · Sep 1990
BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT
K902801 · Beckman Instruments, Inc. · Jul 1990
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · Synermed, Inc. · Jun 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
COULTER TOTAL BILIRUBIN REAGENT
K901266 · Coulter Corp. · Apr 1990