Cleared Traditional

K180099 - Optilite High Sensitivity C-Reactive Protein Kit (FDA 510(k) Clearance)

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

K180099 · The Binding Site Group , Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
269d
Days
Class 2
Risk

K180099 is an FDA 510(k) clearance for the Optilite High Sensitivity C-Reactive Protein Kit. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on October 12, 2018 after a review of 269 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry 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 Chemistry 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 K180099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date October 12, 2018
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
181d slower than avg
Panel avg: 88d · This submission: 269d
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 Chemistry devices follow this clearance model.