Cleared Traditional

K051915 - FREELITE HUMAN KAPPA AND LAMBDA FREE KI...

K051915 is the FDA 510(k) clearance for FREELITE HUMAN KAPPA AND LAMBDA FREE KI... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K051915 · The Binding Site, Ltd. · Immunology device
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Sep 2005
Decision
53d
Days
Class 2
Risk

K051915 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANA.... Classified as Kappa, Antigen, Antiserum, Control (product code DFH), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 6, 2005 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5550 - 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, Ltd. devices

Submission Details

510(k) Number K051915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2005
Decision Date September 06, 2005
Days to Decision 53 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
51d faster than avg
Panel avg: 104d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DFH Kappa, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5550
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 - DFH Kappa, Antigen, Antiserum, Control

All 39
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K003669 · The Binding Site, Ltd. · Feb 2001