Cleared Traditional

K810306 - RHEUMATOID FACTOR REAGENT TEST KIT

K810306 is an FDA 510(k) clearance for RHEUMATOID FACTOR REAGENT TEST KIT, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K810306 · Beckman Instruments, Inc. · Immunology device
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Mar 1981
Decision
34d
Days
Class 2
Risk

K810306 is an FDA 510(k) clearance for the RHEUMATOID FACTOR REAGENT TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 34 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 Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K810306

510(k) Number K810306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1981
Decision Date March 11, 1981
Days to Decision 34 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
70d faster than avg
Panel avg: 104d · This submission: 34d
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 92
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K810306.
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · Intl. Diagnostic Technology · Nov 1981
RA LATEX TEST
K812972 · Oxoid U.S.A., Inc. · Nov 1981
RHEUMATEX
K812882 · Armkel, LLC · Oct 1981
RHEUMATOID FACTORS REFERENCE SERUM
K810404 · Calbiochem-Behring Corp. · Mar 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · Syn-Kit, Inc. · Jan 1981
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980