Cleared Traditional

K102673 - RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM

K102673 is an FDA 510(k) clearance for RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM, manufactured by Phadia US, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K102673 · Phadia US, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
379d
Days
Class 2
Risk

K102673 is an FDA 510(k) clearance for the RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Phadia US, Inc. (Portage, US). The FDA issued a Cleared decision on September 30, 2011 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 - K102673

510(k) Number K102673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2010
Decision Date September 30, 2011
Days to Decision 379 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
275d slower than avg
Panel avg: 104d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DHR Device Classification - Class 2, Special Controls

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 Peers - DHR System, Test, Rheumatoid Factor

All 96
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K102673.
Optilite Rheumatoid Factor Kit
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N LATEX RF KIT
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VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 16, VITROS CHEMISTRY PRODUCTS FS
K041863 · Ortho-Clinical Diagnostics, Inc. · Sep 2004