Cleared Traditional

K920010 - IL TEST COMPLEMENT 4

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

K920010 · Instrumentation Laboratory CO · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920010

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
34d faster than avg
Panel avg: 105d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBI Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (DBI) and FDA review panel - the closest regulatory comparables to K920010.
N-ASSAY TIA MULTI V-NL
K964300 · Crestat Diagnostics, Inc. · Jul 1997
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
SPQ(TM) ANTIBODY REAGENT SET II FOR C4
K890564 · Atlantic Antibodies · Feb 1989