Cleared Traditional

K896271 - QUANTEX RF PLUS (LATEX

K896271 is the FDA 510(k) clearance for QUANTEX RF PLUS (LATEX by Biokit USA, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K896271 · Biokit USA, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1989
Decision
9d
Days
Class 2
Risk

K896271 is an FDA 510(k) clearance for the QUANTEX RF PLUS (LATEX, BUFFER STANDARD, 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 November 8, 1989 after a review of 9 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 K896271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1989
Decision Date November 08, 1989
Days to Decision 9 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 104d · This submission: 9d
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 K896271.
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
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · Biosearch Medical Products, Inc. · Jun 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · Biosearch Medical Products, Inc. · Jun 1989