Cleared Traditional

K860424 - A-GENT LIQUID TOTAL BILIRUBIN

K860424 is an FDA 510(k) clearance for A-GENT LIQUID TOTAL BILIRUBIN, manufactured by Abbott Laboratories. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K860424 · Abbott Laboratories · Chemistry device
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Apr 1986
Decision
58d
Days
Class 2
Risk

K860424 is an FDA 510(k) clearance for the A-GENT LIQUID TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on April 3, 1986 after a review of 58 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K860424

510(k) Number K860424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1986
Decision Date April 03, 1986
Days to Decision 58 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
30d faster than avg
Panel avg: 88d · This submission: 58d
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 185
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K860424.
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
K861413 · Medical Analysis Systems, Inc. · Apr 1986
BILIRUBIN ASSAY KIT (DIRECT), CATA. NUMBER 202-02
K861094 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1986
BILIRUBIN ASSAY KIT (TOTAL), CATA. NUMBER 202-04
K861095 · Diagnostic Chemicals, Ltd. (Usa) · Apr 1986
TOTAL BILIRUBIN REAGENT SET
K860214 · Sterling Diagnostics, Inc. · Mar 1986
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · Em Diagnostic Systems, Inc. · Mar 1986
DIRECT BILIRUBIN
K860257 · Pointe Scientific, Inc., · Feb 1986