Cleared Traditional

K153301 - Elecsys Digoxin Immunoassay

K153301 is the FDA 510(k) clearance for Elecsys Digoxin Immunoassay by Roche Diagnostics. It is a Class 2 Chemistry device (product code KXT) cleared through the Traditional 510(k) pathway after a 147-day FDA review.

K153301 · Roche Diagnostics · Chemistry device
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Apr 2016
Decision
147d
Days
Class 2
Risk

K153301 is an FDA 510(k) clearance for the Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on April 8, 2016 after a review of 147 days - within the typical 510(k) review window.

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: 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.

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Submission Details

510(k) Number K153301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2015
Decision Date April 08, 2016
Days to Decision 147 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
59d slower than avg
Panel avg: 88d · This submission: 147d
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 59
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K153301.
ADVIA Centaur® Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
RANDOX DIGOXIN ASSAY
K102346 · Randox Laboratories, Ltd. · Oct 2011
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