Cleared Traditional

K012311 - IMMULITE 2000 GENTAMICIN

K012311 is the FDA 510(k) clearance for IMMULITE 2000 GENTAMICIN by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code LCD) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K012311 · Diagnostic Products Corp. · Chemistry device
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Aug 2001
Decision
28d
Days
Class 2
Risk

K012311 is an FDA 510(k) clearance for the IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS). Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on August 20, 2001 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3450 - the FDA in vitro diagnostics and chemistry 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 K012311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2001
Decision Date August 20, 2001
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Chemistry devices follow this clearance model.

Regulatory Peers - LCD Enzyme Immunoassay, Gentamicin

All 28
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K012311.
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479 · Ortho-Clinical Diagnostics, Inc. · Jan 2005
ROCHE ONLINE GENTAMICIN
K020704 · Roche Diagnostics Corp. · Jul 2002
RANDOX GENTAMICIN
K012978 · Randox Laboratories, Ltd. · Sep 2001
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · Behring Diagnostics, Inc. · Sep 1996
ACS GENTAMICIN
K953020 · Ciba Corning Diagnostics Corp. · Aug 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995