Cleared Traditional

K193397 - ADVIA Centaur Digoxin assay

K193397 is the FDA 510(k) clearance for ADVIA Centaur Digoxin assay by Siemens Healthcare Diagnostics, Inc.. It is a Class 2 Toxicology device (product code KXT) cleared through the Traditional 510(k) pathway after a 588-day FDA review.

K193397 · Siemens Healthcare Diagnostics, Inc. · Toxicology device
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Jul 2021
Decision
588d
Days
Class 2
Risk

K193397 is an FDA 510(k) clearance for the ADVIA Centaur® Digoxin assay. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Siemens Healthcare Diagnostics, Inc. (Tarrytown, US). The FDA issued a Cleared decision on July 16, 2021 after a review of 588 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device 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 Toxicology submissions.

View all Siemens Healthcare Diagnostics, Inc. devices

Submission Details

510(k) Number K193397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2019
Decision Date July 16, 2021
Days to Decision 588 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
501d slower than avg
Panel avg: 87d · This submission: 588d
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 Toxicology devices follow this clearance model.

Regulatory Peers - KXT Enzyme Immunoassay, Digoxin

All 69
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K193397.
Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II
K153301 · Roche Diagnostics · Apr 2016
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