Cleared Traditional

K071712 - LEUKO EZ VUE

K071712 is an FDA 510(k) clearance for LEUKO EZ VUE, manufactured by Techlab Inc., Corporate Research Center. The device is a Class 1 Immunology device with product code DEG cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K071712 · Techlab Inc., Corporate Research Center · Immunology device
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Dec 2007
Decision
165d
Days
Class 1
Risk

K071712 is an FDA 510(k) clearance for the LEUKO EZ VUE. Classified as Lactoferrin, Antigen, Antiserum, Control (product code DEG), Class I - General Controls.

Submitted by Techlab Inc., Corporate Research Center (Blacksburg, US). The FDA issued a Cleared decision on December 4, 2007 after a review of 165 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Techlab Inc., Corporate Research Center devices

FDA 510(k) Submission Details - K071712

510(k) Number K071712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2007
Decision Date December 04, 2007
Days to Decision 165 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 105d · This submission: 165d
Pathway characteristics
Predicate-based equivalence.

DEG Device Classification - Class 1, General Controls

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.