Cleared Traditional

K920010 - IL TEST COMPLEMENT 4

K920010 is the FDA 510(k) clearance for IL TEST COMPLEMENT 4 by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code DBI) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K920010 · Instrumentation Laboratory CO · Immunology device
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Mar 1992
Decision
71d
Days
Class 2
Risk

K920010 is an FDA 510(k) clearance for the IL TEST COMPLEMENT 4. Classified as Complement C4, Antigen, Antiserum, Control (product code DBI), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on March 13, 1992 after a review of 71 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Instrumentation Laboratory CO devices

Submission Details

510(k) Number K920010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 02, 1992
Decision Date March 13, 1992
Days to Decision 71 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
33d faster than avg
Panel avg: 104d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DBI Complement C4, 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 - DBI Complement C4, Antigen, Antiserum, Control

All 22
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K920010.
C4
K983356 · Abbott Laboratories · Nov 1998
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996
QUANTEX C4
K962198 · Instrumentation Laboratory CO · Sep 1996
RAICHEM SPIA C4 REAGENT
K911899 · Reagents Applications, Inc. · May 1991
EZ COMPLEMENT C4
K892129 · Diamedix Corp. · Apr 1989
COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM
K882621 · Technicon Instruments Corp. · Jul 1988