Cleared Traditional

K991467 - K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET

K991467 is an FDA 510(k) clearance for K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET, manufactured by Kamiya Biomedical Co.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K991467 · Kamiya Biomedical Co. · Immunology device
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Jun 1999
Decision
44d
Days
Class 2
Risk

K991467 is an FDA 510(k) clearance for the K-ASSAY RHEUMATOID FACTOR CALIBRATOR SET. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on June 10, 1999 after a review of 44 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 Kamiya Biomedical Co. devices

FDA 510(k) Submission Details - K991467

510(k) Number K991467 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1999
Decision Date June 10, 1999
Days to Decision 44 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 105d · This submission: 44d
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 110
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K991467.
AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
K994338 · Cogent Diagnotics , Ltd. · Feb 2000
MDI RF TEST
K993843 · Micro Detect, Inc. · Jan 2000
AUTOSTAT II RHEUMATOID FACTOR IGG ELISA
K993304 · Cogent Diagnotics , Ltd. · Dec 1999
K-ASSAY RHEUMATOID FACTOR
K991409 · Kamiya Biomedical Co. · Jun 1999
ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01
K990587 · Bio-Rad · Apr 1999
RF
K990035 · Abbott Laboratories · Mar 1999