Cleared Traditional

K042071 - IBD-SCAN (FDA 510(k) Clearance)

Class I Immunology device.

K042071 · Techlab, Inc. · Immunology device
Oct 2004
Decision
79d
Days
Class 1
Risk

K042071 is an FDA 510(k) clearance for the IBD-SCAN. Classified as Lactoferrin, Antigen, Antiserum, Control (product code DEG), Class I - General Controls.

Submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on October 20, 2004 after a review of 79 days — a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5570 — the FDA immunology 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.

Submission Details

510(k) Number K042071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2004
Decision Date October 20, 2004
Days to Decision 79 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Regulatory Context
Review time vs. panel average
198d faster than avg
Panel avg: 277d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DEG Lactoferrin, Antigen, Antiserum, Control
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.5570
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.