Cleared Traditional

K031563 - BINDAZYME CLQ CIC EIA KIT

K031563 is the FDA 510(k) clearance for BINDAZYME CLQ CIC EIA KIT by The Binding Site, Ltd.. It is a Class 2 Immunology device (product code DAK) cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K031563 · The Binding Site, Ltd. · Immunology device
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Sep 2003
Decision
114d
Days
Class 2
Risk

K031563 is an FDA 510(k) clearance for the BINDAZYME CLQ CIC EIA KIT. Classified as Complement C1q, Antigen, Antiserum, Control (product code DAK), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5240 - 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 K031563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date September 10, 2003
Days to Decision 114 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
10d slower than avg
Panel avg: 104d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DAK Complement C1q, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5240
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 - DAK Complement C1q, Antigen, Antiserum, Control

All 13
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K031563.
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968 · Kent Laboratories, Inc. · May 1995
C1 RID KIT
K914388 · The Binding Site, Ltd. · Oct 1991
IC MICROASSAY
K864312 · Diamedix Corp. · Jan 1987
CORDIA IC
K844294 · Cordis Corp. · Feb 1985
ORTHO* SERUM ELISA TEST SYSTEM
K833636 · Ortho Diagnostic Systems, Inc. · Jun 1984
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949 · Ortho Diagnostic Systems, Inc. · Aug 1982