Cleared Traditional

K002564 - SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN...

K002564 is the FDA 510(k) clearance for SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN... by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DFH) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K002564 · The Binding Site, Ltd. · Immunology device
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Oct 2000
Decision
70d
Days
Class 2
Risk

K002564 is an FDA 510(k) clearance for the SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT. 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 October 26, 2000 after a review of 70 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 K002564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2000
Decision Date October 26, 2000
Days to Decision 70 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
34d faster than avg
Panel avg: 104d · This submission: 70d
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 K002564.
FREELITE HUMAN KAPPA AND LAMBDA KITS
K040009 · The Binding Site, Ltd. · Mar 2004
FREELITE HUMAN KAPPA AND HUMAN LAMBDA FREE KITS FOR USE ON THE HITACHI 911/912 ANALYZER
K023009 · The Binding Site, Ltd. · Jan 2003
KAPPA IMMAGE FREELITE KIT
K003669 · The Binding Site, Ltd. · Feb 2001
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG
K964260 · Beckman Instruments, Inc. · Feb 1997
BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS)
K902484 · Beckman Instruments, Inc. · Jun 1990
BECKMAN LAMBDA LIGHT CHAIN REAGENT
K884597 · Beckman Instruments, Inc. · Dec 1988