Cleared Traditional

K010441 - FREELITE KAPPA FREE KIT

K010441 is the FDA 510(k) clearance for FREELITE KAPPA FREE KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DEH) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K010441 · The Binding Site, Ltd. · Immunology device
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Apr 2001
Decision
72d
Days
Class 2
Risk

K010441 is an FDA 510(k) clearance for the FREELITE KAPPA FREE KIT. Classified as Lambda, Antigen, Antiserum, Control (product code DEH), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 26, 2001 after a review of 72 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 K010441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2001
Decision Date April 26, 2001
Days to Decision 72 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
32d faster than avg
Panel avg: 104d · This submission: 72d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DEH Lambda, 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 - DEH Lambda, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (DEH) and FDA review panel - the closest regulatory comparables to K010441.
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II
K031016 · The Binding Site, Ltd. · Jul 2003
FREELITE HUMAN LAMBDA FREE KIT
K023131 · The Binding Site, Ltd. · Jan 2003
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K010440 · The Binding Site, Ltd. · Apr 2001
LAMBDA IMMAGE FREELITE KIT
K003671 · The Binding Site, Ltd. · Feb 2001
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002563 · The Binding Site, Ltd. · Oct 2000
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING
K971905 · Dako Corp. · Dec 1997