Cleared Traditional

K182747 - EliA RF IgM Immunoassay

K182747 is the FDA 510(k) clearance for EliA RF IgM Immunoassay by Phadia AB. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K182747 · Phadia AB · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2018
Decision
81d
Days
Class 2
Risk

K182747 is an FDA 510(k) clearance for the EliA RF IgM Immunoassay. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Phadia AB (Uppsala, SE). The FDA issued a Cleared decision on December 18, 2018 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Phadia AB devices

Submission Details

510(k) Number K182747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date December 18, 2018
Days to Decision 81 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
23d faster than avg
Panel avg: 104d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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, Inc.
Sheryl Skinner

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 - DHR System, Test, Rheumatoid Factor

All 60
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K182747.
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · Kamiya Biomedical Company · May 2020
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
K060201 · Olympus America, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
K041863 · Ortho-Clinical Diagnostics, Inc. · Sep 2004
ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM
K033802 · Zeus Scientific, Inc. · Feb 2004