Cleared Traditional

K861998 - TOTAL BILIRUBIN TEST KIT

K861998 is an FDA 510(k) clearance for TOTAL BILIRUBIN TEST KIT, manufactured by Ciba Corning Diagnostics Corp.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K861998 · Ciba Corning Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K861998

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.

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 K861998.
BILIFAST
K863055 · J. D. Assoc. · Sep 1986
METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
K862359 · E.I. Dupont DE Nemours & Co., Inc. · Aug 1986
AMRESCO FLOW PAC TOTAL BILIRUBIN REAGENTS
K862299 · Amresco, Inc. · Jul 1986
DIRECT BILIRUBIN PROCEDURE
K861671 · Data Medical Associates, Inc. · Jun 1986
TOTAL BILIRUBIN PROCEDURE
K861651 · Data Medical Associates, Inc. · May 1986
BILIRUBIN*SR (TOTAL) LIQUID STABLE REAGENT SET
K861413 · Medical Analysis Systems, Inc. · Apr 1986