Cleared Traditional

K904310 - RHEUMAGEN RF T-CONTROL

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

K904310 · Biokit USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K904310

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
149d slower than avg
Panel avg: 105d · This submission: 254d
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 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K904310.
RF STAT IGM TEST KIT
K920753 · Biowhittaker Molecular Applications, Inc. · Mar 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220 · Akers Research Corp. · Mar 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
RHEUMAJET RF
K910539 · Biokit USA, Inc. · Apr 1991
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
K904498 · Biotrax, Inc. · Oct 1990
V-TREND TARGET RF TEST
K904105 · Texas Immunology, Inc. · Oct 1990
K904310 · RHEUMAGEN RF T-CONTROL
Download PDF Biokit USA, Inc.