Cleared Traditional

ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT (K880743) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K880743 · Abbott Laboratories · Chemistry device
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Apr 1988
Decision
41d
Days
Class 2
Risk

K880743 is an FDA 510(k) clearance for the ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT. 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 5, 1988 after a review of 41 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

Submission Details

510(k) Number K880743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1988
Decision Date April 05, 1988
Days to Decision 41 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
47d faster than avg
Panel avg: 88d · This submission: 41d
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 88
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K880743.
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · Em Diagnostic Systems, Inc. · Jan 1989
VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM
K880437 · Abbott Laboratories · Aug 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · Technicon Instruments Corp. · Jun 1988
IQ/QCA TOTAL BILIRUBIN
K874261 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987
REFLOTRON BILIRUBIN
K872818 · Boehringer Mannheim Corp. · Nov 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
K873551 · Em Diagnostic Systems, Inc. · Oct 1987