Cleared Traditional

K102346 - RANDOX DIGOXIN ASSAY

K102346 is the FDA 510(k) clearance for RANDOX DIGOXIN ASSAY by Randox Laboratories, Ltd.. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K102346 · Randox Laboratories, Ltd. · Chemistry device
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Oct 2011
Decision
421d
Days
Class 2
Risk

K102346 is an FDA 510(k) clearance for the RANDOX DIGOXIN ASSAY. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on October 14, 2011 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3320 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K102346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2010
Decision Date October 14, 2011
Days to Decision 421 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
333d slower than avg
Panel avg: 88d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXT Enzyme Immunoassay, Digoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3320
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 - KXT Enzyme Immunoassay, Digoxin

All 64
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K102346.
ADVIA Centaur® Digoxin assay
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Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · Roche Diagnostics · Apr 2016
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435
K093441 · Siemens Healthcare Diagnostics · Apr 2010
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)
K012301 · Diagnostic Products Corp. · Sep 2001
RANDOX DIGOXIN
K011302 · Randox Laboratories, Ltd. · Jul 2001