Cleared Traditional

K920014 - IL TEST IMMUNOGLOBULIN A

K920014 is the FDA 510(k) clearance for IL TEST IMMUNOGLOBULIN A by Instrumentation Laboratory CO. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K920014 · Instrumentation Laboratory CO · Immunology device
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Jun 1992
Decision
166d
Days
Class 2
Risk

K920014 is an FDA 510(k) clearance for the IL TEST IMMUNOGLOBULIN A. Classified as Iga, Antigen, Antiserum, Control (product code CZP), 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 866.5510 - 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 K920014 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 CZP Iga, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CZP Iga, Antigen, Antiserum, Control

All 36
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K920014.
BOEHRINGER MANNHEIM IGA ASSAY
K955907 · Boehringer Mannheim Corp. · Feb 1996
N LATEX IGA
K952309 · Behring Diagnostics, Inc. · Jun 1995
IGA SUBCLASS RID KIT FOR DIAGNOSTIC USE
K931806 · The Binding Site, Ltd. · Jul 1993
TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046
K900422 · Helena Laboratories · Feb 1990
RAICHEM(TM) SPIA(TM) IGA REAGENTS
K894418 · Reagents Applications, Inc. · Aug 1989
TECHNICON DPA-1 IMMUNOGLOBULIN A
K883492 · Technicon Instruments Corp. · Sep 1988