Cleared Traditional

K161982 - C-Reactive Protein 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.

K161982 · The Binding Site Group · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
260d
Days
Class 2
Risk

K161982 is an FDA 510(k) clearance for the C-Reactive Protein Kit for use on SPAPLUS. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by The Binding Site Group (Birmingham, GB). The FDA issued a Cleared decision on April 5, 2017 after a review of 260 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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.

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Submission Details

510(k) Number K161982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2016
Decision Date April 05, 2017
Days to Decision 260 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 104d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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.