Cleared Traditional

K802448 - RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.

K802448 is the FDA 510(k) clearance for RA 80 EIKEN KIT DETERM. OF RHEUMATIC F. by Syn-Kit, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K802448 · Syn-Kit, Inc. · Immunology device
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Jan 1981
Decision
89d
Days
Class 2
Risk

K802448 is an FDA 510(k) clearance for the RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Syn-Kit, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 5, 1981 after a review of 89 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 Syn-Kit, Inc. devices

Submission Details

510(k) Number K802448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1980
Decision Date January 05, 1981
Days to Decision 89 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
15d faster than avg
Panel avg: 104d · This submission: 89d
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 84
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K802448.
RHEUMATEX
K812882 · Armkel, LLC · Oct 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · Beckman Instruments, Inc. · Mar 1981
RHEUMATOID FACTORS REFERENCE SERUM
K810404 · Calbiochem-Behring Corp. · Mar 1981
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1980
ANTI-GLOBULIN CONTROL
K792695 · Meridian Diagnostics, Inc. · Jan 1980