Cleared Traditional

K023009 - FREELITE HUMAN KAPPA AND HUMAN LAMBDA F...

K023009 is the FDA 510(k) clearance for FREELITE HUMAN KAPPA AND HUMAN LAMBDA F... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K023009 · The Binding Site, Ltd. · Immunology device
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Jan 2003
Decision
134d
Days
Class 2
Risk

K023009 is an FDA 510(k) clearance for the FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/91.... 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 January 21, 2003 after a review of 134 days - within the typical 510(k) review window.

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: 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.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K023009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date January 21, 2003
Days to Decision 134 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
30d slower than avg
Panel avg: 104d · This submission: 134d
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
Devices cleared under the same product code (DFH) and FDA review panel - the closest regulatory comparables to K023009.
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE SPAPLUS ANALYZER
K062372 · The Binding Site, Ltd. · Jun 2007
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE BAYER ADVIA 1650 ANALYZER
K051915 · The Binding Site, Ltd. · Sep 2005
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · The Binding Site, Ltd. · Mar 2004
KAPPA IMMAGE FREELITE KIT
K003669 · The Binding Site, Ltd. · Feb 2001
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002564 · The Binding Site, Ltd. · Oct 2000
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
K964260 · Beckman Instruments, Inc. · Feb 1997