Cleared Traditional

K840486 - TOTAL BILIRUBIN REAGENT

K840486 is the FDA 510(k) clearance for TOTAL BILIRUBIN REAGENT by Somas Medical Industries, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K840486 · Somas Medical Industries, Inc. · Chemistry device
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Apr 1984
Decision
79d
Days
Class 2
Risk

K840486 is an FDA 510(k) clearance for the TOTAL BILIRUBIN REAGENT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Somas Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 25, 1984 after a review of 79 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 Somas Medical Industries, Inc. devices

Submission Details

510(k) Number K840486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1984
Decision Date April 25, 1984
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 88d · This submission: 79d
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 173
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K840486.
RAICHEM BILIRUBIN REAGENT TOTAL/DIRECT
K841892 · Reagents Applications, Inc. · Jun 1984
DIRECT BILIRUBIN REAGENT
K841572 · Hi Chem, Inc. · May 1984
TOTAL BILIRUBIN REAGENT SET
K841050 · Medical Specialties, Inc. · May 1984
EKTACHEM CLINICAL CHEM. SLIDES
K840880 · Eastman Kodak Company · Apr 1984
NEONATAL BILIRUBIN REAGENT
K840779 · American Dade · Apr 1984
DIRECT BILIRUBIN REAGENT
K840777 · American Dade · Apr 1984