Cleared Traditional

K083117 - ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MODELS 14-5511-01, 14-5506-01 AND 14-5507-01

K083117 is an FDA 510(k) clearance for ELIA RNP70 IMMUNOASSAY, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code LKO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K083117 · Phadia US, Inc. · Immunology device
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May 2009
Decision
218d
Days
Class 2
Risk

K083117 is an FDA 510(k) clearance for the ELIA RNP70 IMMUNOASSAY, ELIA SCI-70 IMMUNOASSAY AND ELIA JO-1 IMMUNOASSAY, MO.... Classified as Anti-rnp Antibody, Antigen And Control (product code LKO), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on May 28, 2009 after a review of 218 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 US, Inc. devices

FDA 510(k) Submission Details - K083117

510(k) Number K083117 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 22, 2008
Decision Date May 28, 2009
Days to Decision 218 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
113d slower than avg
Panel avg: 105d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKO Device Classification - Class 2, Special Controls

Product Code LKO Anti-rnp Antibody, Antigen And Control
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 - LKO Anti-rnp Antibody, Antigen And Control

All 18
Devices cleared under the same product code (LKO) and FDA review panel - the closest regulatory comparables to K083117.
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