Cleared Traditional

K160819 - Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit (FDA 510(k) Clearance)

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

K160819 · The Binding Site Group , Ltd. · Immunology device
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Jun 2016
Decision
84d
Days
Class 2
Risk

K160819 is an FDA 510(k) clearance for the Optilite Hevylite IgA Kappa Kit, Optilite Hevylite IgA Lambda Kit. Classified as Immunoglobulin A Kappa Heavy & Light Chain Combined (product code OPX), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on June 16, 2016 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all The Binding Site Group , Ltd. devices

Submission Details

510(k) Number K160819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2016
Decision Date June 16, 2016
Days to Decision 84 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
20d faster than avg
Panel avg: 104d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OPX Immunoglobulin A Kappa Heavy & Light Chain Combined
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
Definition Intended For The In-vitro Quantification Of Iga Kappa Concentration In Human Serum. The Result Is To Be Used With Previously Diagnosed Iga Multiple Myeloma, In Conjunction With Other Clinical And Laboratory Findings. For Previously Diagnosed Iga Multiple Myeloma Patients.
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.