Cleared Traditional

K974607 - RANDOX CALCIUM

K974607 is the FDA 510(k) clearance for RANDOX CALCIUM by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code CJY) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K974607 · Randox Laboratories, Ltd. · Chemistry device
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Feb 1998
Decision
54d
Days
Class 2
Risk

K974607 is an FDA 510(k) clearance for the RANDOX CALCIUM. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, Co. Antrim, IE). The FDA issued a Cleared decision on February 2, 1998 after a review of 54 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 K974607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1997
Decision Date February 02, 1998
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
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
Devices cleared under the same product code (CJY) and FDA review panel - the closest regulatory comparables to K974607.
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HICHEM CALCIUM REAGENT KIT
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CA
K981578 · Abbott Laboratories · Jun 1998
SIGMA DIAGNOSTICS CALICIUM REAGENT
K963536 · Sigma Diagnostics, Inc. · Oct 1996
SYNERMED CALCIUM REAGENT KIT
K953395 · Synermed, Inc. · Aug 1995
DMA CALCIUM PLUS PROCEDURE
K944255 · Data Medical Associates, Inc. · Dec 1994