Cleared Traditional

K132631 - EIA SMDP IMMUNOASSAY

K132631 is an FDA 510(k) clearance for EIA SMDP IMMUNOASSAY, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code LKP cleared through the Traditional 510(k) pathway after a 372-day FDA review.

K132631 · Phadia US, Inc. · Immunology device
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Aug 2014
Decision
372d
Days
Class 2
Risk

K132631 is an FDA 510(k) clearance for the EIA SMDP IMMUNOASSAY. Classified as Anti-sm Antibody, Antigen And Control (product code LKP), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on August 29, 2014 after a review of 372 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 - K132631

510(k) Number K132631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 2013
Decision Date August 29, 2014
Days to Decision 372 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
268d slower than avg
Panel avg: 104d · This submission: 372d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKP Device Classification - Class 2, Special Controls

Product Code LKP Anti-sm 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 - LKP Anti-sm Antibody, Antigen And Control

All 17
Devices cleared under the same product code (LKP) and FDA review panel - the closest regulatory comparables to K132631.
EliA SmDP-S
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THERATEST EL-ANA PROFILES
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