Cleared Traditional

K140493 - ELIA SCL-70S IMMUNOASSAY

K140493 is an FDA 510(k) clearance for ELIA SCL-70S IMMUNOASSAY, manufactured by Phadia GmbH. The device is a Class 2 Immunology device with product code LJM cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K140493 · Phadia GmbH · Immunology device
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Oct 2014
Decision
245d
Days
Class 2
Risk

K140493 is an FDA 510(k) clearance for the ELIA SCL-70S IMMUNOASSAY. Classified as Antinuclear Antibody (enzyme-labeled), Antigen, Controls (product code LJM), Class II - Special Controls.

Submitted by Phadia GmbH (Portage, US). The FDA issued a Cleared decision on October 30, 2014 after a review of 245 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 Phadia GmbH devices

FDA 510(k) Submission Details - K140493

510(k) Number K140493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2014
Decision Date October 30, 2014
Days to Decision 245 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
141d slower than avg
Panel avg: 104d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJM Device Classification - Class 2, Special Controls

Product Code LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5100
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 - LJM Antinuclear Antibody (enzyme-labeled), Antigen, Controls

All 66
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