Cleared Special

IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT (K060130) - FDA 510(k) Clearance

Class II Immunology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K060130 · Beckman Coulter, Inc. · Immunology device
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Optimized for regulatory review, auditing and printing
Feb 2006
Decision
26d
Days
Class 2
Risk

K060130 is an FDA 510(k) clearance for the IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT. Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on February 13, 2006 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - the FDA immunology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Beckman Coulter, Inc. devices

Submission Details

510(k) Number K060130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2006
Decision Date February 13, 2006
Days to Decision 26 days
Submission Type Special
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
78d faster than avg
Panel avg: 104d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 53
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K060130.
Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K193525 · HORIBA ABX SAS · Jun 2020
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp. · Mar 2004
N LATEX IGA
K024038 · Dade Behring, Inc. · Feb 2003
IGA
K983359 · Abbott Laboratories · Nov 1998
QUANTEX IGA
K962200 · Instrumentation Laboratory CO · Sep 1996
BOEHRINGER MANNHEIM IGA ASSAY
K955907 · Boehringer Mannheim Corp. · Feb 1996