Cleared Traditional

K920007 - IL TEST COMPLEMENT 3

K920007 is the FDA 510(k) clearance for IL TEST COMPLEMENT 3 by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code CZW) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K920007 · Instrumentation Laboratory CO · Immunology device
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Jun 1992
Decision
166d
Days
Class 2
Risk

K920007 is an FDA 510(k) clearance for the IL TEST COMPLEMENT 3. Classified as Complement C3, Antigen, Antiserum, Control (product code CZW), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on June 16, 1992 after a review of 166 days - an extended review cycle.

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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K920007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date June 16, 1992
Days to Decision 166 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 104d · This submission: 166d
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 Immunology devices follow this clearance model.

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

All 28
Devices cleared under the same product code (CZW) and FDA review panel - the closest regulatory comparables to K920007.
QUANTEX C3
K962199 · Instrumentation Laboratory CO · Sep 1996
N PROTEIN STANDARS SY
K955857 · Behring Diagnostics, Inc. · Feb 1996
N PROTEIN STANDARD SY
K952594 · Behring Diagnostics, Inc. · Jul 1995
RAICHEM SPIA C3 REAGENT
K911900 · Reagents Applications, Inc. · May 1991
C3C AND C4 RID KITS
K902382 · The Binding Site, Ltd. · Sep 1990
EZ COMPLEMENT C2
K892125 · Diamedix Corp. · Apr 1989