Cleared Traditional

K831467 - RA-CHECK

K831467 is an FDA 510(k) clearance for RA-CHECK, manufactured by Diagnostic Technology, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K831467 · Diagnostic Technology, Inc. · Immunology device
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Jun 1983
Decision
33d
Days
Class 2
Risk

K831467 is an FDA 510(k) clearance for the RA-CHECK. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Diagnostic Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 33 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 Diagnostic Technology, Inc. devices

FDA 510(k) Submission Details - K831467

510(k) Number K831467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1983
Decision Date June 08, 1983
Days to Decision 33 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
71d faster than avg
Panel avg: 104d · This submission: 33d
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 95
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K831467.
RF TEST KIT
K841454 · Difco Laboratories, Inc. · Apr 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · Diagnostic Products Corp. · Feb 1984
SERO/TEX RED CELL RF TEST
K831597 · Texas Immunology, Inc. · Jun 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · Emd Chemicals, Inc. · Apr 1983
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905 · Fisher Scientific Co., LLC · Oct 1982
RHEUMATOID FACTOR REFERENCE PREPARA.
K821941 · Armkel, LLC · Aug 1982