Cleared Traditional

K854181 - IN-VITRO TEST DETERMINATION OF ALBUMIN

K854181 is the FDA 510(k) clearance for IN-VITRO TEST DETERMINATION OF ALBUMIN by Clinical Data, Inc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K854181 · Clinical Data, Inc. · Chemistry device
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Nov 1985
Decision
41d
Days
Class 2
Risk

K854181 is an FDA 510(k) clearance for the IN-VITRO TEST DETERMINATION OF ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), 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 862.1035 - 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

Submission Details

510(k) Number K854181 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
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.

Device Classification

Product Code CIX Bromcresol Green Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
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 - CIX Bromcresol Green Dye-binding, Albumin

All 56
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K854181.
ALBUMIN PROCEDURE
K863263 · Data Medical Associates, Inc. · Sep 1986
ALBUMIN PROCEDURE
K861654 · Data Medical Associates, Inc. · Jun 1986
ALBUMIN (BCG) REAGENT
K861467 · Sigma Diagnostics, Inc. · May 1986
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · Medical Analysis Systems, Inc. · Sep 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · Technicon Instruments Corp. · Apr 1985