Cleared Traditional

K863263 - ALBUMIN PROCEDURE

K863263 is the FDA 510(k) clearance for ALBUMIN PROCEDURE by Data Medical Associates, Inc.. It is a Class 2 Toxicology device (product code CIX) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K863263 · Data Medical Associates, Inc. · Toxicology device
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Sep 1986
Decision
21d
Days
Class 2
Risk

K863263 is an FDA 510(k) clearance for the ALBUMIN PROCEDURE. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by Data Medical Associates, Inc. (Arlington, US). The FDA issued a Cleared decision on September 15, 1986 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.1035 - the FDA toxicology device 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 Data Medical Associates, Inc. devices

Submission Details

510(k) Number K863263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1986
Decision Date September 15, 1986
Days to Decision 21 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 87d · This submission: 21d
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 Toxicology devices follow this clearance model.

Regulatory Peers - CIX Bromcresol Green Dye-binding, Albumin

All 77
Devices cleared under the same product code (CIX) and FDA review panel - the closest regulatory comparables to K863263.
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
K873994 · Em Diagnostic Systems, Inc. · Oct 1987
ALBUMIN REAGENT - BROMCRESOL GREEN METHOD
K870372 · Trace Scientific , Ltd. · Aug 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
K864715 · Em Diagnostic Systems, Inc. · Dec 1986
ALBUMETER
K863050 · J. D. Assoc. · Sep 1986
ALBUMIN PROCEDURE
K861654 · Data Medical Associates, Inc. · Jun 1986
ALBUMIN (BCG) REAGENT
K861467 · Sigma Diagnostics, Inc. · May 1986