Cleared Traditional

K192727 - K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)

K192727 is an FDA 510(k) clearance for K-ASSAY RF (Ver.2), manufactured by Kamiya Biomedical Company. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 236-day FDA review.

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

FDA 510(k) Submission Details - K192727

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
131d slower than avg
Panel avg: 105d · This submission: 236d
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 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
Optilite Rheumatoid Factor Kit
K162263 · The Binding Site Group , Ltd. · May 2017
Rheumatoid Factor (RF) Kit for use on SPAPLUS
K160070 · The Binding Site Group , Ltd. · Dec 2016
ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA, ImmuLisa Enhanced RF IgM Antibody ELISA, ImmuLisa Enhanced RF Antibody Screen ELISA
K143736 · Immco Diagnostics, Inc. · Sep 2015
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · Phadia US, Inc. · Sep 2011