Cleared Traditional

K041863 - VITROS CHEMISTRY PRODUCTS RF REAGENT

K041863 is the FDA 510(k) clearance for VITROS CHEMISTRY PRODUCTS RF REAGENT by Ortho-Clinical Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K041863 · Ortho-Clinical Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
73d
Days
Class 2
Risk

K041863 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS RF REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KI.... Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on September 20, 2004 after a review of 73 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K041863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2004
Decision Date September 20, 2004
Days to Decision 73 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
31d faster than avg
Panel avg: 104d · This submission: 73d
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 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K041863.
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K060201 · Olympus America, Inc. · Jun 2006
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K033802 · Zeus Scientific, Inc. · Feb 2004
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RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003