Cleared Traditional

K160070 - Rheumatoid Factor (RF) Kit for use on SPAPLUS

K160070 is an FDA 510(k) clearance for Rheumatoid Factor (RF) Kit for use on S..., manufactured by The Binding Site Group , Ltd.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 329-day FDA review.

K160070 · The Binding Site Group , Ltd. · Immunology device
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Dec 2016
Decision
329d
Days
Class 2
Risk

K160070 is an FDA 510(k) clearance for the Rheumatoid Factor (RF) Kit for use on SPAPLUS. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on December 7, 2016 after a review of 329 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 The Binding Site Group , Ltd. devices

FDA 510(k) Submission Details - K160070

510(k) Number K160070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2016
Decision Date December 07, 2016
Days to Decision 329 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
224d slower than avg
Panel avg: 105d · This submission: 329d
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 K160070.
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
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
N LATEX RF KIT
K071247 · Dade Behring, Inc. · Aug 2007