Cleared Traditional

K020704 - ROCHE ONLINE GENTAMICIN

K020704 is an FDA 510(k) clearance for ROCHE ONLINE GENTAMICIN, manufactured by Roche Diagnostics Corp.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K020704 · Roche Diagnostics Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
130d
Days
Class 2
Risk

K020704 is an FDA 510(k) clearance for the ROCHE ONLINE GENTAMICIN. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on July 12, 2002 after a review of 130 days - within the typical 510(k) review window.

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: 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 Roche Diagnostics Corp. devices

FDA 510(k) Submission Details - K020704

510(k) Number K020704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2002
Decision Date July 12, 2002
Days to Decision 130 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
43d slower than avg
Panel avg: 87d · This submission: 130d
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 K020704.
ARCHITECT IGENTAMICIN REAGENTS
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MULTIGENT GENTAMICIN
K060709 · Seradyn, Inc. · Jun 2006
VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS
K042479 · Ortho-Clinical Diagnostics, Inc. · Jan 2005
RANDOX GENTAMICIN
K012978 · Randox Laboratories, Ltd. · Sep 2001
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