Cleared Traditional

K850296 - LASER RF TEST -RHEUMATOID FACTOR(S) REA...

K850296 is the FDA 510(k) clearance for LASER RF TEST -RHEUMATOID FACTOR(S) REA... by Behring Diagnostics, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K850296 · Behring Diagnostics, Inc. · Immunology device
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Apr 1985
Decision
78d
Days
Class 2
Risk

K850296 is an FDA 510(k) clearance for the LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on April 12, 1985 after a review of 78 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K850296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 1985
Decision Date April 12, 1985
Days to Decision 78 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
26d faster than avg
Panel avg: 104d · This submission: 78d
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 82
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K850296.
RF MICROASSAY
K871041 · Diamedix Corp. · Mar 1987
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · Hemagen Diagnostics, Inc. · Apr 1986
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · Behring Diagnostics, Inc. · Jun 1985
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · Abbott Laboratories · Mar 1985
RHEUMADX LATEX AGGLUTINATION RHEUMATOID
K843896 · Diagnostic Products Corp. · Oct 1984
RF TEST KIT
K841454 · Difco Laboratories, Inc. · Apr 1984