Cleared Traditional

K904310 - RHEUMAGEN RF T-CONTROL

K904310 is the FDA 510(k) clearance for RHEUMAGEN RF T-CONTROL by Biokit USA, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K904310 · Biokit USA, Inc. · Immunology device
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May 1991
Decision
254d
Days
Class 2
Risk

K904310 is an FDA 510(k) clearance for the RHEUMAGEN RF T-CONTROL. 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 May 31, 1991 after a review of 254 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 Biokit USA, Inc. devices

Submission Details

510(k) Number K904310 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date May 31, 1991
Days to Decision 254 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 104d · This submission: 254d
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 85
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K904310.
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
RAPITEX(R) RF NEW
K903852 · Behring Diagnostics, Inc. · Aug 1990
MODIFIED QM300 RHEUMATOID FACTOR TEST
K902462 · Kallestad Diag, A Div. of Erbamont, Inc. · Jun 1990
TECHNICON DPA-1 SYSTEM RF METHOD
K894574 · Technicon Instruments Corp. · Aug 1989