Cleared Traditional

K151113 - ELITech Clinical Systems CALCIUM ARSENAZO

K151113 is the FDA 510(k) clearance for ELITech Clinical Systems CALCIUM ARSENAZO by Elitechgroup. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K151113 · Elitechgroup · Chemistry device
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Jul 2015
Decision
86d
Days
Class 2
Risk

K151113 is an FDA 510(k) clearance for the ELITech Clinical Systems CALCIUM ARSENAZO. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Elitechgroup (Sees, FR). The FDA issued a Cleared decision on July 22, 2015 after a review of 86 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 Elitechgroup devices

Submission Details

510(k) Number K151113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2015
Decision Date July 22, 2015
Days to Decision 86 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 88d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K151113.
Calcium2
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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