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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - DEG Lactoferrin, Antigen, Antiserum, Control

All 7
Devices cleared under the same product code (DEG) and FDA review panel - the closest regulatory comparables to K071712.
IBD-SCAN
K042071 · Techlab, Inc. · Oct 2004
IBD-QUIK CHEK
K030704 · Techlab, Inc. · Apr 2003
IBD-CHEK
K011396 · Techlab, Inc. · Jun 2001
LEUKO-TEST
K951101 · Techlab, Inc. · Apr 1995
LACTOFERRIN MICROASSAY SYSTEM
K934473 · Touch Scientific, Inc. · Dec 1993
LACTOCARD
K931901 · Touch Scientific, Inc. · Jul 1993
K071712 · LEUKO EZ VUE
Download PDF FDA Summary Techlab Inc., Corpora…