Cleared Traditional

K012112 - RANDOX DIGITOXIN

K012112 is an FDA 510(k) clearance for RANDOX DIGITOXIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K012112

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.

LFM Device Classification - Class 2, Special Controls

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 17
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
ACS DIGITOXIN
K970546 · Chiron Diagnostics Corp. · Jul 1997
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