Cleared Traditional

C3C AND C4 RID KITS (K902382) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K902382 · The Binding Site, Ltd. · Chemistry device
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Sep 1990
Decision
100d
Days
Class 2
Risk

K902382 is an FDA 510(k) clearance for the C3C AND C4 RID KITS. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on September 7, 1990 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5240 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all The Binding Site, Ltd. devices

Submission Details

510(k) Number K902382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 1990
Decision Date September 07, 1990
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 88d · This submission: 100d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CZW Complement C3, 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 Chemistry devices follow this clearance model.

Regulatory Peers - CZW Complement C3, Antigen, Antiserum, Control

All 43
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K902382.
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K061852 · Dade Behring, Inc. · Sep 2006
N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)
K050665 · Dade Behring, Inc. · May 2005
SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI
K032035 · Beckman Coulter, Inc. · Aug 2003
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · Roche Diagnostics Corp. · Nov 2001
DIMENSION C3 FLEX REAGENT CARTRIDGE
K994296 · Dade Behring, Inc. · Mar 2000
C3
K983441 · Abbott Laboratories · Nov 1998