Cleared Traditional

K193525 - Yumizen C1200 Immunoglobulin A

K193525 is an FDA 510(k) clearance for Yumizen C1200 Immunoglobulin A, manufactured by HORIBA ABX SAS. The device is a Class 2 Immunology device with product code CZP cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K193525 · HORIBA ABX SAS · Immunology device
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Jun 2020
Decision
190d
Days
Class 2
Risk

K193525 is an FDA 510(k) clearance for the Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200.... Classified as Iga, Antigen, Antiserum, Control (product code CZP), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on June 26, 2020 after a review of 190 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 HORIBA ABX SAS devices

FDA 510(k) Submission Details - K193525

510(k) Number K193525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2019
Decision Date June 26, 2020
Days to Decision 190 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
86d slower than avg
Panel avg: 104d · This submission: 190d
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 44
Devices cleared under the same product code (CZP) and FDA review panel - the closest regulatory comparables to K193525.
IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT
K060130 · Beckman Coulter, Inc. · Feb 2006
ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2
K040435 · Roche Diagnostics Corp. · Mar 2004
N LATEX IGA
K024038 · Dade Behring, Inc. · Feb 2003
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