Cleared Traditional

K812882 - RHEUMATEX

K812882 is an FDA 510(k) clearance for RHEUMATEX, manufactured by Armkel, LLC. The device is a Class 2 Microbiology device with product code DHR cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K812882 · Armkel, LLC · Microbiology device
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Oct 1981
Decision
12d
Days
Class 2
Risk

K812882 is an FDA 510(k) clearance for the RHEUMATEX. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Armkel, LLC (Walker, US). The FDA issued a Cleared decision on October 26, 1981 after a review of 12 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.

View all Armkel, LLC devices

FDA 510(k) Submission Details - K812882

510(k) Number K812882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1981
Decision Date October 26, 1981
Days to Decision 12 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
90d faster than avg
Panel avg: 102d · This submission: 12d
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 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K812882.
SERO/TEX RF TEST
K821319 · Texas Immunology, Inc. · May 1982
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · Intl. Diagnostic Technology · Nov 1981
RA LATEX TEST
K812972 · Oxoid U.S.A., Inc. · Nov 1981
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · Beckman Instruments, Inc. · Mar 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