Cleared Traditional

K902801 - BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T...

K902801 is an FDA 510(k) clearance for BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T..., manufactured by Beckman Instruments, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K902801 · Beckman Instruments, Inc. · Chemistry device
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Jul 1990
Decision
20d
Days
Class 2
Risk

K902801 is an FDA 510(k) clearance for the BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on July 17, 1990 after a review of 20 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K902801

510(k) Number K902801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1990
Decision Date July 17, 1990
Days to Decision 20 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
68d faster than avg
Panel avg: 88d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIG Device Classification - Class 2, Special Controls

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 178
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K902801.
COULTER DIRECT BILLRUBIN REAGENT
K905622 · Coulter Electronics, Inc. · Dec 1990
DIAZO COLORIMENTRY DIRECT BILIRUBIN
K904381 · Amresco, Inc. · Oct 1990
SYNERMED DIRECT BILIRUBIN REAGENT KIT
K903728 · Synermed, Inc. · Sep 1990
SYNERMED TOTAL BILIRUBIN REAGENT KIT
K902328 · Synermed, Inc. · Jun 1990
COULTER DIRECT BILIRUBIN
K902199 · Coulter Corp. · Jun 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
K902123 · Em Diagnostic Systems, Inc. · Jun 1990