Cleared Traditional

K191562 - Yumizen C1200 Ferritin

K191562 is an FDA 510(k) clearance for Yumizen C1200 Ferritin, manufactured by HORIBA ABX SAS. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K191562 · HORIBA ABX SAS · Immunology device
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Mar 2020
Decision
267d
Days
Class 2
Risk

K191562 is an FDA 510(k) clearance for the Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid F.... Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on March 6, 2020 after a review of 267 days - an extended review cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - 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 - K191562

510(k) Number K191562 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2019
Decision Date March 06, 2020
Days to Decision 267 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
163d slower than avg
Panel avg: 104d · This submission: 267d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

Product Code DBF Ferritin, Antigen, Antiserum, Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5340
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 - DBF Ferritin, Antigen, Antiserum, Control

All 64
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K191562.
LIAISON Ferritin
K193650 · DiaSorin, Inc. · Sep 2021
Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc. · Aug 2017
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
K133083 · Diazyme Laboratories · Jun 2014
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · Siemens Healthcare Diagnostics, Inc. · Aug 2011
TINA-QUANT FERRITIN GEN. 4
K100538 · Roche Diagnostics · Jun 2010
BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203
K092505 · Beckman Coulter, Inc. · Dec 2009