Cleared Traditional

K850931 - ALBUMIN

K850931 is an FDA 510(k) clearance for ALBUMIN, manufactured by Dilab, Inc.. The device is a Class 2 Chemistry device with product code CIX cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K850931 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
111d
Days
Class 2
Risk

K850931 is an FDA 510(k) clearance for the ALBUMIN. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 111 days - within the typical 510(k) review window.

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: 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 Dilab, Inc. devices

FDA 510(k) Submission Details - K850931

510(k) Number K850931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 26, 1985
Days to Decision 111 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 88d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIX Device Classification - Class 2, Special Controls

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 107
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K850931.
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · Medical Analysis Systems, Inc. · Sep 1985
ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
K853049 · Simmler, Inc. · Aug 1985
ALB BCG REAGENT
K852007 · Alpkem Corp. · May 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · Technicon Instruments Corp. · Apr 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
K844330 · Advanced Biomedical Methods, Inc. · Jan 1985