Cleared Traditional

K122965 - HUMAN CAERULOPLASMIN KIT

K122965 is the FDA 510(k) clearance for HUMAN CAERULOPLASMIN KIT by The Binding Site Group , Ltd.. It is a Class 2 Immunology device (product code DDB) cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K122965 · The Binding Site Group , Ltd. · Immunology device
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Jun 2013
Decision
252d
Days
Class 2
Risk

K122965 is an FDA 510(k) clearance for the HUMAN CAERULOPLASMIN KIT. Classified as Ceruloplasmin, Antigen, Antiserum, Control (product code DDB), Class II - Special Controls.

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on June 3, 2013 after a review of 252 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5210 - 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 Group , Ltd. devices

Submission Details

510(k) Number K122965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2012
Decision Date June 03, 2013
Days to Decision 252 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
148d slower than avg
Panel avg: 104d · This submission: 252d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DDB Ceruloplasmin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5210
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 - DDB Ceruloplasmin, Antigen, Antiserum, Control

All 13
Devices cleared under the same product code (DDB) and FDA review panel - the closest regulatory comparables to K122965.
N ANTISERA TO HUMAN CERULOPLASMIN
K053074 · Dade Behring, Inc. · Mar 2006
IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT
K964762 · Beckman Instruments, Inc. · Apr 1997
CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT
K913668 · The Binding Site, Ltd. · Dec 1991
QM300 CERULOPLASMIN ANTIBODY PACK
K895377 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1989
NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM
K860138 · Sigma Diagnostics, Inc. · Mar 1986
LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)
K852247 · Behring Diagnostics, Inc. · Jul 1985