Cleared Traditional

K904105 - V-TREND TARGET RF TEST

K904105 is an FDA 510(k) clearance for V-TREND TARGET RF TEST, manufactured by Texas Immunology, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K904105 · Texas Immunology, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1990
Decision
39d
Days
Class 2
Risk

K904105 is an FDA 510(k) clearance for the V-TREND TARGET RF TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Texas Immunology, Inc. (Tyler, US). The FDA issued a Cleared decision on October 15, 1990 after a review of 39 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.

FDA 510(k) Submission Details - K904105

510(k) Number K904105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1990
Decision Date October 15, 1990
Days to Decision 39 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
66d faster than avg
Panel avg: 105d · This submission: 39d
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 K904105.
RHEUMAGEN RF T-CONTROL
K904310 · Biokit USA, Inc. · May 1991
RHEUMAJET RF
K910539 · Biokit USA, Inc. · Apr 1991
CROMATEST RHEUMATOID DIAGNOSTIC/RF LATEX TEST
K904498 · Biotrax, Inc. · Oct 1990
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
QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)
K896271 · Biokit USA, Inc. · Nov 1989
K904105 · V-TREND TARGET RF TEST
Download PDF Texas Immunology, Inc.