Cleared Traditional

TOTAL LIPIDS (K863073) - FDA 510(k) Clearance

Class I Chemistry device.

K863073 · J. D. Assoc. · Chemistry device
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Sep 1986
Decision
28d
Days
Class 1
Risk

K863073 is an FDA 510(k) clearance for the TOTAL LIPIDS. Classified as Sulfophosphovanillin, Colorimetry, Total Lipids (product code CFD), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on September 9, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1470 - 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 K863073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1986
Decision Date September 09, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CFD Sulfophosphovanillin, Colorimetry, Total Lipids
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1470
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.