Cleared Traditional

K120626 - EON CALCIUM REGENT

K120626 is an FDA 510(k) clearance for EON CALCIUM REGENT, manufactured by Vital Diagnostics (Manufacturing) Ptyltd. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K120626 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry device
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Aug 2012
Decision
174d
Days
Class 2
Risk

K120626 is an FDA 510(k) clearance for the EON CALCIUM REGENT. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on August 22, 2012 after a review of 174 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Vital Diagnostics (Manufacturing) Ptyltd devices

FDA 510(k) Submission Details - K120626

510(k) Number K120626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date August 22, 2012
Days to Decision 174 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 88d · This submission: 174d
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 41
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K120626.
Randox Calcium (Ca)
K182042 · Randox Laboratories, Ltd. · Oct 2018
ELITech Clinical Systems CALCIUM ARSENAZO
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ABX PENTRA CALCIUM AS CP, ABX PENTRA URINE CONTROL L/H, ABX PENTRA MULTICAL, ABX PENTRA N CONTROL, AND ABX PENTRA P CONT
K123171 · HORIBA ABX SAS · Jul 2013
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
S-TEST CA
K072356 · Alfa Wassermann Diagnostic Technologies, Inc. · Jun 2008
VITROS CHEMISTRY PRODUCTS CA DT SLIDES AND DT CALIBRATOR KIT AND VITROS CA ASSAY
K072443 · Ortho-Clinical Diagnostics, Inc. · Sep 2007