Cleared Traditional

K012978 - RANDOX GENTAMICIN

K012978 is an FDA 510(k) clearance for RANDOX GENTAMICIN, manufactured by Randox Laboratories, Ltd.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K012978 · Randox Laboratories, Ltd. · Toxicology device
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Sep 2001
Decision
74d
Days
Class 2
Risk

K012978 is an FDA 510(k) clearance for the RANDOX GENTAMICIN. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Randox Laboratories, Ltd. (Crumlin, IE). The FDA issued a Cleared decision on September 18, 2001 after a review of 74 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - 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 Randox Laboratories, Ltd. devices

FDA 510(k) Submission Details - K012978

510(k) Number K012978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2001
Decision Date September 18, 2001
Days to Decision 74 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
13d faster than avg
Panel avg: 87d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCD Device Classification - Class 2, Special Controls

Product Code LCD Enzyme Immunoassay, Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 - LCD Enzyme Immunoassay, Gentamicin

All 35
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K012978.
MULTIGENT GENTAMICIN
K060709 · Seradyn, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479 · Ortho-Clinical Diagnostics, Inc. · Jan 2005
ROCHE ONLINE GENTAMICIN
K020704 · Roche Diagnostics Corp. · Jul 2002
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · Diagnostic Products Corp. · Aug 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · Syva Co., Dade Behring, Inc. · Apr 2001
GENTAMICIN FLEX REAGENT CARTRIDGE
K962819 · Dade Intl., Inc. · Sep 1996