Cleared Traditional

K012112 - RANDOX DIGITOXIN

K012112 is the FDA 510(k) clearance for RANDOX DIGITOXIN by Randox Laboratories, Ltd.. It is a Class 2 Toxicology device (product code LFM) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K012112 · Randox Laboratories, Ltd. · Toxicology device
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Jan 2002
Decision
189d
Days
Class 2
Risk

K012112 is an FDA 510(k) clearance for the RANDOX DIGITOXIN. Classified as Enzyme Immunoassay, Digitoxin (product code LFM), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on January 11, 2002 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Randox Laboratories, Ltd. devices

Submission Details

510(k) Number K012112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date January 11, 2002
Days to Decision 189 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFM Enzyme Immunoassay, Digitoxin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3300
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 - LFM Enzyme Immunoassay, Digitoxin

All 16
Devices cleared under the same product code (LFM) and FDA review panel - the closest regulatory comparables to K012112.
DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE
K062024 · Dade Behring, Inc. · Jul 2006
DGTX FLEX REAGENT CARTRIDGE, MODEL DF36
K990251 · Dade Behring, Inc. · Mar 1999
ABBOTT AXSYM DIGITOXIN (MODIFY)
K963158 · Abbott Laboratories · Sep 1996
AXSYM DIGITOXIN
K954420 · Abbott Laboratories · Dec 1995
DIGOXIN ASSAY FOR THE TECCHNICON RA/OPERA SYSTEMS IN-VITRO DIAGNOSTIC SYSTEMS
K951631 · Bayer Corp. · Jun 1995
IMMULITE DIGITOXIN
K943235 · Diagnostic Products Corp. · Oct 1994