Cleared Traditional

K962198 - QUANTEX C4

K962198 is an FDA 510(k) clearance for QUANTEX C4, 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 111-day FDA review.

K962198 · Instrumentation Laboratory CO · Immunology device
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Sep 1996
Decision
111d
Days
Class 2
Risk

K962198 is an FDA 510(k) clearance for the QUANTEX C4. 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 September 26, 1996 after a review of 111 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K962198

510(k) Number K962198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1996
Decision Date September 26, 1996
Days to Decision 111 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
6d slower than avg
Panel avg: 105d · This submission: 111d
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 K962198.
N-ASSAY TIA C4 TEST KIT
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N-ASSAY TIA MULTI V-NL
K964300 · Crestat Diagnostics, Inc. · Jul 1997
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · Olympus America, Inc. · Oct 1996
IL TEST COMPLEMENT 4
K920010 · Instrumentation Laboratory CO · Mar 1992
RAICHEM SPIA C4 REAGENT
K911899 · Reagents Applications, Inc. · May 1991
EZ COMPLEMENT C4
K892129 · Diamedix Corp. · Apr 1989