Cleared Traditional

K880437 - VISION TOTAL BILIRUBIN WITH A NEONATAL ...

K880437 is an FDA 510(k) clearance for VISION TOTAL BILIRUBIN WITH A NEONATAL ..., 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 183-day FDA review.

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

FDA 510(k) Submission Details - K880437

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.

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 K880437.
TOTAL BILIRUBIN REAGENT, CONCENTRATED
K890070 · Trace Scientific , Ltd. · Mar 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
BILIRUBIN (DIRECT)
K881172 · Tech-Co, Inc. · Jun 1988
TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN
K881798 · Technicon Instruments Corp. · Jun 1988
DIRECT BILIRUBIN PROCEDURE
K881166 · Data Medical Associates, Inc. · Apr 1988