Cleared Traditional

K071346 - IMMULISA INTRINSIC FACTOR ANTIBODY ELISA

K071346 is an FDA 510(k) clearance for IMMULISA INTRINSIC FACTOR ANTIBODY ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code LIG cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K071346 · Immco Diagnostics, Inc. · Immunology device
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Sep 2007
Decision
133d
Days
Class 2
Risk

K071346 is an FDA 510(k) clearance for the IMMULISA INTRINSIC FACTOR ANTIBODY ELISA. Classified as Radioassay, Intrinsic Factor Blocking Antibody (product code LIG), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on September 24, 2007 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.1810 - 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 Immco Diagnostics, Inc. devices

FDA 510(k) Submission Details - K071346

510(k) Number K071346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2007
Decision Date September 24, 2007
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 104d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIG Device Classification - Class 2, Special Controls

Product Code LIG Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1810
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 Immunology devices follow this clearance model.

Regulatory Peers - LIG Radioassay, Intrinsic Factor Blocking Antibody

All 7
Devices cleared under the same product code (LIG) and FDA review panel - the closest regulatory comparables to K071346.
Access Intrinsic Factor Ab
K240800 · Beckman Coulter, Inc. · May 2024
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · Inova Diagnostics, Inc. · Dec 2006
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
K033603 · Beckman Coulter, Inc. · Dec 2003
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
K993251 · Diagnostic Products Corp. · Nov 1999
ABBOTT ARCHITECT B12
K984108 · Abbott Laboratories · Feb 1999
IMX B12
K903218 · Abbott Laboratories · Aug 1990