Cleared Traditional

K141375 - ELIA M2

Also marketed or referenced as:
IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

K141375 is an FDA 510(k) clearance for ELIA M2, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code DBM cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K141375 · Phadia US, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K141375

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
Combination Product No
PCCP Authorized No
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.

DBM Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control

All 17
Devices cleared under the same product code (DBM) and FDA review panel - the closest regulatory comparables to K141375.
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K052262 · Inova Diagnostics, Inc. · Oct 2005
BINDAZYME ANTI-MITOCHONDRIA M2 IGGAM EIA KIT
K030238 · The Binding Site, Ltd. · Mar 2003
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · Trace Scientific , Ltd. · Sep 1998