Cleared Traditional

K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) (K192727) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192727 · Kamiya Biomedical Company · Immunology device
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May 2020
Decision
236d
Days
Class 2
Risk

K192727 is an FDA 510(k) clearance for the K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2). Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Kamiya Biomedical Company (Tukwila, US). The FDA issued a Cleared decision on May 20, 2020 after a review of 236 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Kamiya Biomedical Company devices

Submission Details

510(k) Number K192727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2019
Decision Date May 20, 2020
Days to Decision 236 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
132d slower than avg
Panel avg: 104d · This submission: 236d
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 143
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K192727.
QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents
K190088 · Inova Diagnostics, Inc. · Apr 2019
EliA RF IgM Immunoassay
K182747 · Phadia AB · Dec 2018
RHEUMATOID FACTOR (RF)
K024067 · Abbott Laboratories · Jan 2003
RF
K990035 · Abbott Laboratories · Mar 1999
ABBOTT RF EIA DIAGNOSTIC KIT
K850373 · Abbott Laboratories · Mar 1985
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980