Cleared Traditional

K863050 - ALBUMETER

K863050 is the FDA 510(k) clearance for ALBUMETER by J. D. Assoc.. It is a Class 2 Chemistry device (product code CIX) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K863050 · J. D. Assoc. · Chemistry device
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Sep 1986
Decision
30d
Days
Class 2
Risk

K863050 is an FDA 510(k) clearance for the ALBUMETER. Classified as Bromcresol Green Dye-binding, Albumin (product code CIX), Class II - Special Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 11, 1986 after a review of 30 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 J. D. Assoc. devices

Submission Details

510(k) Number K863050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date September 11, 1986
Days to Decision 30 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
58d faster than avg
Panel avg: 88d · This submission: 30d
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 K863050.
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
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
AMRESCO FLOW PAC ALBUMIN BROMOCRESOL GREEN REAGENT
K860661 · Amresco, Inc. · Mar 1986