Cleared Traditional

K955794 - IGA IMMUNOTURBIDIMETRIC & CALIBRATOR

K955794 is the FDA 510(k) clearance for IGA IMMUNOTURBIDIMETRIC & CALIBRATOR by Randox Laboratories, Ltd.. It is a Class 2 Immunology device (product code CZP) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K955794 · Randox Laboratories, Ltd. · Immunology device
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Apr 1996
Decision
105d
Days
Class 2
Risk

K955794 is an FDA 510(k) clearance for the IGA IMMUNOTURBIDIMETRIC & CALIBRATOR. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on April 5, 1996 after a review of 105 days - within the typical 510(k) review window.

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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K955794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date April 05, 1996
Days to Decision 105 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 104d · This submission: 105d
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 42
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K955794.
WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
K993927 · Wako Chemicals USA, Inc. · Jan 2000
IGA
K983359 · Abbott Laboratories · Nov 1998
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996
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