Cleared Traditional

K100499 - ORGENTEC RHEUMATOID FACTOR EIA

K100499 is an FDA 510(k) clearance for ORGENTEC RHEUMATOID FACTOR EIA, manufactured by Orgentec Diagnostika GmbH. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K100499 · Orgentec Diagnostika GmbH · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
247d
Days
Class 2
Risk

K100499 is an FDA 510(k) clearance for the ORGENTEC RHEUMATOID FACTOR EIA. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Orgentec Diagnostika GmbH (East Stroudsburg, US). The FDA issued a Cleared decision on October 27, 2010 after a review of 247 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Orgentec Diagnostika GmbH devices

FDA 510(k) Submission Details - K100499

510(k) Number K100499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2010
Decision Date October 27, 2010
Days to Decision 247 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
142d slower than avg
Panel avg: 105d · This submission: 247d
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 K100499.
Rheumatoid Factor (RF) Kit for use on SPAPLUS
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RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
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N LATEX RF KIT
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OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105.
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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