Cleared Traditional

K902382 - C3C AND C4 RID KITS

K902382 is an FDA 510(k) clearance for C3C AND C4 RID KITS, manufactured by The Binding Site, Ltd.. The device is a Class 2 Chemistry device with product code CZW cleared through the Traditional 510(k) pathway after a 100-day FDA review.

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

FDA 510(k) Submission Details - K902382

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
Combination Product No
PCCP Authorized No
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.

CZW Device Classification - Class 2, Special Controls

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 35
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K902382.
N PROTEIN STANDARD SY
K952594 · Behring Diagnostics, Inc. · Jul 1995
IL TEST COMPLEMENT 3
K920007 · Instrumentation Laboratory CO · Jun 1992
RAICHEM SPIA C3 REAGENT
K911900 · Reagents Applications, Inc. · May 1991
EZ COMPLEMENT C2
K892125 · Diamedix Corp. · Apr 1989
EZ COMPLEMENT C3
K892127 · Diamedix Corp. · Apr 1989
THE TURBOX ANALYSER SYSTEM COMPLEMENT C3 AND C4
K890675 · Unipath , Ltd. · Mar 1989