Cleared Traditional

ORGENTEC RHEUMATOID FACTOR EIA (K100499) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100499 · Orgentec Diagnostika GmbH · Immunology device
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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

Submission Details

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
143d slower than avg
Panel avg: 104d · This submission: 247d
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 Peers - DHR System, Test, Rheumatoid Factor

All 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K100499.
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RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003
RF
K990035 · Abbott Laboratories · Mar 1999