Cleared Traditional

K191396 - Yumizen C1200 Calcium AS

K191396 is an FDA 510(k) clearance for Yumizen C1200 Calcium AS, manufactured by HORIBA ABX SAS. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K191396 · HORIBA ABX SAS · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2019
Decision
63d
Days
Class 2
Risk

K191396 is an FDA 510(k) clearance for the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by HORIBA ABX SAS (Montpellier Cedex 4, FR). The FDA issued a Cleared decision on July 26, 2019 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all HORIBA ABX SAS devices

FDA 510(k) Submission Details - K191396

510(k) Number K191396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2019
Decision Date July 26, 2019
Days to Decision 63 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 88d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 Chemistry devices follow this clearance model.

Regulatory Peers - CJY Azo Dye, Calcium

All 34
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K191396.
Calcium2
K244042 · Abbott Ireland · Feb 2025
Randox Calcium (Ca)
K182042 · Randox Laboratories, Ltd. · Oct 2018
ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL)
K083386 · Siemens Healthcare Diagnostics · Apr 2009
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · Ortho-Clinical Diagnostics, Inc. · Sep 2007
VITROS CHEMISTRY PRODUCTS: CA SLIDES (MODEL: 145 0261), CALIBRATORS KIT 1 (MODEL: 188 2208)
K072440 · Ortho-Clinical Diagnostics, Inc. · Sep 2007
CALCIUM
K062855 · Abbott Laboratories · Nov 2006