Cleared Traditional

K896271 - QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)

K896271 is an FDA 510(k) clearance for QUANTEX RF PLUS (LATEX, 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 9-day FDA review.

K896271 · Biokit USA, Inc. · Immunology device
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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

FDA 510(k) Submission Details - K896271

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
96d faster than avg
Panel avg: 105d · This submission: 9d
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 112
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K896271.
V-TREND TARGET RF TEST
K904105 · Texas Immunology, 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
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