Cleared Traditional

K810404 - RHEUMATOID FACTORS REFERENCE SERUM

K810404 is an FDA 510(k) clearance for RHEUMATOID FACTORS REFERENCE SERUM, manufactured by Calbiochem-Behring Corp.. The device is a Class 2 Microbiology device with product code DHR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K810404 · Calbiochem-Behring Corp. · Microbiology device
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Mar 1981
Decision
21d
Days
Class 2
Risk

K810404 is an FDA 510(k) clearance for the RHEUMATOID FACTORS REFERENCE SERUM. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Calbiochem-Behring Corp. (Mchenry, US). The FDA issued a Cleared decision on March 11, 1981 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5775 - the FDA microbiology 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.

FDA 510(k) Submission Details - K810404

510(k) Number K810404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1981
Decision Date March 11, 1981
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
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 Microbiology devices follow this clearance model.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K810404.
RHEUMATEX
K812882 · Armkel, LLC · Oct 1981
BI-RA SLIDE TEST
K811375 · Biologics Intl., Inc. · Jun 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · Beckman Instruments, Inc. · Mar 1981
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
K810141 · Scripps-Miles, Inc. · Feb 1981
SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
K810221 · Scripps-Miles, Inc. · Feb 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · Syn-Kit, Inc. · Jan 1981
K810404 · RHEUMATOID FACTORS REFERENCE SERUM
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