Cleared Traditional

K984045 - RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS

K984045 is the FDA 510(k) clearance for RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS by Kamiya Biomedical Co.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K984045 · Kamiya Biomedical Co. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
73d
Days
Class 2
Risk

K984045 is an FDA 510(k) clearance for the RF CONTROL FOR IMMUNOTURBIDIMETRIC ASSAYS. 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 January 25, 1999 after a review of 73 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

Submission Details

510(k) Number K984045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1998
Decision Date January 25, 1999
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 104d · This submission: 73d
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 78
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K984045.
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
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL
K983418 · Zeus Scientific, Inc. · Nov 1998
QUANTA LITE RF IGG ELISA
K983083 · Inova Diagnostics, Inc. · Nov 1998
QUANTA LITE RF IGA ELISA
K983084 · Inova Diagnostics, Inc. · Nov 1998