Cleared Traditional

K160070 - Rheumatoid Factor (RF) Kit for use on SPAPLUS (FDA 510(k) Clearance)

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

K160070 · The Binding Site Group , Ltd. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 104d · This submission: 329d
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.