Cleared Traditional

K850379 - DIRECT BILIRUBIN FOR DEMAND ANALYZER

K850379 is the FDA 510(k) clearance for DIRECT BILIRUBIN FOR DEMAND ANALYZER by Advanced Biomedical Methods, Inc.. It is a Class 2 Chemistry device (product code CIG) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K850379 · Advanced Biomedical Methods, Inc. · Chemistry device
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Mar 1985
Decision
29d
Days
Class 2
Risk

K850379 is an FDA 510(k) clearance for the DIRECT BILIRUBIN FOR DEMAND ANALYZER. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Advanced Biomedical Methods, Inc. (Niles, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 29 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 Advanced Biomedical Methods, Inc. devices

Submission Details

510(k) Number K850379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1985
Decision Date March 01, 1985
Days to Decision 29 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 88d · This submission: 29d
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 K850379.
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
K852008 · Alpkem Corp. · May 1985
ABBOTT TDT EIA
K843908 · Abbott Laboratories · Apr 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · Data Medical Associates, Inc. · Apr 1985
SYSTEMATE T-BILI 67212
K843328 · Em Diagnostic Systems, Inc. · Sep 1984
SYSTEMATE D-BILI 67213
K843329 · Em Diagnostic Systems, Inc. · Sep 1984
TOTAL BILIRUBIN TEST
K843178 · Sclavo, Inc. · Sep 1984