Cleared Traditional

K920014 - IL TEST IMMUNOGLOBULIN A

K920014 is an FDA 510(k) clearance for IL TEST IMMUNOGLOBULIN A, manufactured by Instrumentation Laboratory CO. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K920014

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
61d slower than avg
Panel avg: 105d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CZP Device Classification - Class 2, Special Controls

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 48
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
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · Atlantic Antibodies · Feb 1989