Cleared Traditional

K143736 - ImmuLisa Enhanced RF IgA Antibody ELISA

K143736 is an FDA 510(k) clearance for ImmuLisa Enhanced RF IgA Antibody ELISA, manufactured by Immco Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K143736 · Immco Diagnostics, Inc. · Immunology device
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Sep 2015
Decision
267d
Days
Class 2
Risk

K143736 is an FDA 510(k) clearance for the ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody EL.... Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on September 23, 2015 after a review of 267 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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 - K143736

510(k) Number K143736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 2014
Decision Date September 23, 2015
Days to Decision 267 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
163d slower than avg
Panel avg: 104d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 - DHR System, Test, Rheumatoid Factor

All 103
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K143736.
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K102673 · Phadia US, Inc. · Sep 2011
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
K060201 · Olympus America, Inc. · Jun 2006