Cleared Traditional

K210902 - EliA Ro52, EliA Ro60

K210902 is an FDA 510(k) clearance for EliA Ro52, manufactured by Phadia AB. The device is a Class 2 Immunology device with product code LKJ cleared through the Traditional 510(k) pathway after a 488-day FDA review.

K210902 · Phadia AB · Immunology device
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Jul 2022
Decision
488d
Days
Class 2
Risk

K210902 is an FDA 510(k) clearance for the EliA Ro52, EliA Ro60. Classified as Antinuclear Antibody, Antigen, Control (product code LKJ), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on July 27, 2022 after a review of 488 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Immunology submissions.

View all Phadia AB devices

FDA 510(k) Submission Details - K210902

510(k) Number K210902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2021
Decision Date July 27, 2022
Days to Decision 488 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
383d slower than avg
Panel avg: 105d · This submission: 488d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKJ Device Classification - Class 2, Special Controls

Product Code LKJ Antinuclear Antibody, Antigen, 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 Consultant

Phadia, US Lnc.
Jane R Anthony

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LKJ Antinuclear Antibody, Antigen, Control

All 36
Devices cleared under the same product code (LKJ) and FDA review panel - the closest regulatory comparables to K210902.
ANA-SCREEN WITH MDSS
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ATHENA MULTI-LYTE ANA-II TEST SYSTEM
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K034013 · Corgenix, Inc. · Jan 2004
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K024218 · Bio-Rad · Jan 2003