Cleared Traditional

AUTOMATED RHEMATOID FACTOR TEST (ARFT) (K800268) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K800268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Immunology device
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Feb 1980
Decision
15d
Days
Class 2
Risk

K800268 is an FDA 510(k) clearance for the AUTOMATED RHEMATOID FACTOR TEST (ARFT). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on February 21, 1980 after a review of 15 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K800268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1980
Decision Date February 21, 1980
Days to Decision 15 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
89d faster than avg
Panel avg: 104d · This submission: 15d
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 33
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K800268.
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · Diagnostic Products Corp. · Feb 1984
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · Beckman Instruments, Inc. · Mar 1981
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
CORDIA RF
K792061 · Cordis Corp. · Nov 1979
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976