Cleared Traditional

K083080 - IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM

K083080 is an FDA 510(k) clearance for IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSA..., manufactured by Sqi Diagnostics Systems. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 378-day FDA review.

K083080 · Sqi Diagnostics Systems · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
378d
Days
Class 2
Risk

K083080 is an FDA 510(k) clearance for the IGX PLEX RHEUMATOID ARTHRITIS (RA) ASSAY AND SQIDWORKS DIAGNOSTICS PLATFORM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Sqi Diagnostics Systems (Toronto, On, CA). The FDA issued a Cleared decision on October 29, 2009 after a review of 378 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 Sqi Diagnostics Systems devices

FDA 510(k) Submission Details - K083080

510(k) Number K083080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 2008
Decision Date October 29, 2009
Days to Decision 378 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
273d slower than avg
Panel avg: 105d · This submission: 378d
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 109
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K083080.
Rheumatoid Factor (RF) Kit for use on SPAPLUS
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K143736 · Immco Diagnostics, Inc. · Sep 2015
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · Phadia US, Inc. · Sep 2011
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