Cleared Traditional

K182042 - Randox Calcium (Ca)

K182042 is the FDA 510(k) clearance for Randox Calcium (Ca) by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K182042 · Randox Laboratories, Ltd. · Chemistry device
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Oct 2018
Decision
85d
Days
Class 2
Risk

K182042 is an FDA 510(k) clearance for the Randox Calcium (Ca). Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on October 23, 2018 after a review of 85 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 Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K182042 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date October 23, 2018
Days to Decision 85 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
3d faster than avg
Panel avg: 88d · This submission: 85d
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 32
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K072440 · Ortho-Clinical Diagnostics, Inc. · Sep 2007
CALCIUM
K062855 · Abbott Laboratories · Nov 2006