Cleared Traditional

IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) (K012301) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K012301 · Diagnostic Products Corp. · Toxicology device
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Sep 2001
Decision
61d
Days
Class 2
Risk

K012301 is an FDA 510(k) clearance for the IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS). Classified as Enzyme Immunoassay, Digoxin (product code KXT), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on September 19, 2001 after a review of 61 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. 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K012301 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2001
Decision Date September 19, 2001
Days to Decision 61 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
26d faster than avg
Panel avg: 87d · This submission: 61d
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 84
Devices cleared under the same product code (KXT) and FDA review panel - the closest regulatory comparables to K012301.
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