Cleared Traditional

TOTAL BILIRUBIN TEST KIT (K861998) - FDA 510(k) Clearance

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

K861998 · Ciba Corning Diagnostics Corp. · Chemistry device
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Jun 1986
Decision
35d
Days
Class 2
Risk

K861998 is an FDA 510(k) clearance for the TOTAL BILIRUBIN TEST KIT. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Ciba Corning Diagnostics Corp. (Oberlin, US). The FDA issued a Cleared decision on June 27, 1986 after a review of 35 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 Ciba Corning Diagnostics Corp. devices

Submission Details

510(k) Number K861998 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1986
Decision Date June 27, 1986
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 97
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K861998.
DIRECT BILIRUBIN PROCEDURE
K863265 · Data Medical Associates, Inc. · Oct 1986
TOTAL BILIRUBIN PROCEDURE
K863262 · Data Medical Associates, Inc. · Sep 1986
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · Data Medical Associates, Inc. · Jun 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · Data Medical Associates, Inc. · May 1986
A-GENT LIQUID TOTAL BILIRUBIN
K860424 · Abbott Laboratories · Apr 1986