Cleared Traditional

K854180 - IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN

K854180 is an FDA 510(k) clearance for IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN, manufactured by Clinical Data, Inc.. The device is a Class 2 Chemistry device with product code CIG cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854180 · Clinical Data, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1985
Decision
41d
Days
Class 2
Risk

K854180 is an FDA 510(k) clearance for the IN-VITRO TEST DETERMINATION TOTAL BILIRUBIN. Classified as Diazo Colorimetry, Bilirubin (product code CIG), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on November 25, 1985 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 Clinical Data, Inc. devices

FDA 510(k) Submission Details - K854180

510(k) Number K854180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date November 25, 1985
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.

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 213
Devices cleared under the same product code (CIG) and FDA review panel - the closest regulatory comparables to K854180.
NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95
K855079 · Em Diagnostic Systems, Inc. · Mar 1986
DIRECT BILIRUBIN
K860257 · Pointe Scientific, Inc., · Feb 1986
DIRECT & TOTAL BILIRUBIN SET
K855195 · Technostics Intl. · Jan 1986
T-BIL REAGENT, D-BIL REAGENT, SODIUM NITRITE & SUL
K852008 · Alpkem Corp. · May 1985
ABBOTT TDT EIA
K843908 · Abbott Laboratories · Apr 1985
DATA CHEM AUTO-BILIRUBIN/DIRECT PROCEDURE
K850901 · Data Medical Associates, Inc. · Apr 1985