Cleared Traditional

VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM (K880437) - FDA 510(k) Clearance

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

K880437 · Abbott Laboratories · Chemistry device
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Aug 1988
Decision
183d
Days
Class 2
Risk

K880437 is an FDA 510(k) clearance for the VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 3, 1988 after a review of 183 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K880437 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1988
Decision Date August 03, 1988
Days to Decision 183 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
95d slower than avg
Panel avg: 88d · This submission: 183d
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 K880437.
CLINISTAT TOTAL BILIRUBIN REAGENT TEST
K892801 · Heraeus Kulzer, Inc. · Aug 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
K885284 · Em Diagnostic Systems, Inc. · Jan 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
K885285 · Em Diagnostic Systems, Inc. · Jan 1989
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · Technicon Instruments Corp. · Jun 1988
ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT
K880743 · Abbott Laboratories · Apr 1988
IQ/QCA TOTAL BILIRUBIN
K874261 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987