Cleared Traditional

K850931 - ALBUMIN

K850931 is the FDA 510(k) clearance for ALBUMIN by Dilab, Inc.. It is a Class 2 Chemistry device (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

Submission Details

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.

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 79
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K850931.
IN-VITRO TEST DETERMINATION OF ALBUMIN
K854181 · Clinical Data, Inc. · Nov 1985
TDX AMYLASE
K853978 · Abbott Laboratories · Oct 1985
ALBUMIN SR LIQUID STABLE REAGENT SET
K853868 · Medical Analysis Systems, Inc. · Sep 1985
ALB BCG REAGENT
K852007 · Alpkem Corp. · May 1985
ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S
K851308 · Technicon Instruments Corp. · Apr 1985
ALBUMIN ASSAY KIT
K843104 · Diagnostic Chemicals, Ltd. (Usa) · Sep 1984