Cleared Traditional

Yumizen C1200 CRP (K192028) - FDA 510(k) Clearance

Class II Immunology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192028 · HORIBA ABX SAS · Immunology device
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Jun 2020
Decision
335d
Days
Class 2
Risk

K192028 is an FDA 510(k) clearance for the Yumizen C1200 CRP. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on June 25, 2020 after a review of 335 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - 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. Elevated predicate reliance profile. 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

Submission Details

510(k) Number K192028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2019
Decision Date June 25, 2020
Days to Decision 335 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
231d slower than avg
Panel avg: 104d · This submission: 335d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 48
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K192028.
K-ASSAY CRP (Ver.2)
K242170 · Kamiya Biomedical Company, LLC · Apr 2025
Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge
K201256 · Procise Diagnostics · Nov 2022
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2
K032663 · Instrumentation Laboratory CO · Dec 2003
WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET
K024280 · Wako Chemicals USA, Inc. · Jun 2003