Cleared Traditional

K031563 - BINDAZYME CLQ CIC EIA KIT

K031563 is an FDA 510(k) clearance for BINDAZYME CLQ CIC EIA KIT, manufactured by The Binding Site, Ltd.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K031563

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
9d slower than avg
Panel avg: 105d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DAK Device Classification - Class 2, Special Controls

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 16
Devices cleared under the same product code (DAK) and FDA review panel - the closest regulatory comparables to K031563.
CIC-C1Q EIA
K012576 · American Laboratory Products Co., Ltd. · Jan 2002
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIES
K973203 · Sangstat Medical Corp. · Sep 1998
IMMUSTRIP HAMA IGG
K972873 · Immunomedics, Inc. · Mar 1998
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