Cleared Traditional

K141375 - ELIA M2 (FDA 510(k) Clearance)

Also includes:
IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

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

K141375 · Phadia US, Inc. · Immunology device
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Feb 2015
Decision
262d
Days
Class 2
Risk

K141375 is an FDA 510(k) clearance for the ELIA M2. Classified as Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (product code DBM), Class II - Special Controls.

Submitted by Phadia US, Inc. (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on February 13, 2015 after a review of 262 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5090 - 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 Phadia US, Inc. devices

Submission Details

510(k) Number K141375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2014
Decision Date February 13, 2015
Days to Decision 262 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
158d slower than avg
Panel avg: 104d · This submission: 262d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5090
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.