Cleared Traditional

K172078 - ImmuLisa Enhanced RNA POL III Antibody ELISA (FDA 510(k) Clearance)

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172078 · Immco Diagnostics, Inc. · Immunology device
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Mar 2018
Decision
263d
Days
Class 2
Risk

K172078 is an FDA 510(k) clearance for the ImmuLisa Enhanced RNA POL III Antibody ELISA. Classified as Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody (product code NYO), Class II - Special Controls.

Submitted by Immco Diagnostics, Inc. (Buffalo, US). The FDA issued a Cleared decision on March 30, 2018 after a review of 263 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5100 - 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

Submission Details

510(k) Number K172078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2017
Decision Date March 30, 2018
Days to Decision 263 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
159d slower than avg
Panel avg: 104d · This submission: 263d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NYO Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
Definition The Anti-rna Polymerase Iii Test Is A Semi-quantitative Elisa For The Detection Of Anti-rna Polymerase Iii Antibodies In Human Serum. The Test Result Is Used As An Aid In The Diagnosis Of Systemic Sclerosis (ssc) In Conjunction With The Clinical And Other Laboratory Findings. For In-vitro Diagnostic Use.
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 - NYO Autoantibodies, Anti-ribonucleic Acid Polymerase (rnap) Iii Antibody

Devices cleared under the same product code (NYO) and FDA review panel - the closest regulatory comparables to K172078.
EliA RNA Pol III
K202541 · Phadia AB · Sep 2021