Cleared Special

EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229 (K011920) - FDA 510(k) Clearance

Class II Toxicology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K011920 · Syva Co., Dade Behring, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
12d
Days
Class 2
Risk

K011920 is an FDA 510(k) clearance for the EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229. Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Syva Co., Dade Behring, Inc. (Cupertino, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3320 - the FDA toxicology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Syva Co., Dade Behring, Inc. devices

Submission Details

510(k) Number K011920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2001
Decision Date July 02, 2001
Days to Decision 12 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 87d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K011920.
ADVIA Centaur® Digoxin assay
K193397 · Siemens Healthcare Diagnostics, Inc. · Jul 2021
AXSYM DIGOXIN III
K061249 · Abbott Laboratories · Jun 2006
ELECSYS DIGOXIN
K973112 · Boehringer Mannheim Corp. · Oct 1997
CEDIA DIGOXIN II
K970883 · Boehringer Mannheim Corp. · May 1997
CEDIA DIGOXIN
K970881 · Boehringer Mannheim Corp. · May 1997
AXSYM DIGOXIN II
K953718 · Abbott Laboratories · Sep 1995