Cleared Traditional

RHEUMAJET RF (K910539) - FDA 510(k) Clearance

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

K910539 · Biokit USA, Inc. · Immunology device
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Apr 1991
Decision
67d
Days
Class 2
Risk

K910539 is an FDA 510(k) clearance for the RHEUMAJET RF. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Biokit USA, Inc. (Barcelona, ES). The FDA issued a Cleared decision on April 5, 1991 after a review of 67 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 Biokit USA, Inc. devices

Submission Details

510(k) Number K910539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1991
Decision Date April 05, 1991
Days to Decision 67 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 104d · This submission: 67d
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 K910539.
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
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QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
EliA RF IgM Immunoassay
K182747 · Phadia AB · Dec 2018
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · Roche Diagnostics Corp. · Sep 2003
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003