Cleared Traditional

Optilite Rheumatoid Factor Kit

K162263 · The Binding Site Group , Ltd. · Immunology
May 2017
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K162263 is an FDA 510(k) clearance for the Optilite Rheumatoid Factor Kit, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on May 3, 2017, 265 days after receiving the submission on August 11, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K162263 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2016
Decision Date May 03, 2017
Days to Decision 265 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

Similar Devices — DHR System, Test, Rheumatoid Factor

All 143
K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2)
K192727 · Kamiya Biomedical Company · May 2020
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) 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