Cleared Traditional

K020704 - ROCHE ONLINE GENTAMICIN

K020704 is the FDA 510(k) clearance for ROCHE ONLINE GENTAMICIN by Roche Diagnostics Corp.. It is a Class 2 Toxicology device (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

Submission Details

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.

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 Toxicology 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 K020704.
ARCHITECT iGentamicin
K243500 · Abbott Laboratories · Jul 2025
ARCHITECT IGENTAMICIN REAGENTS
K102699 · Abbott Laboratories · Apr 2011
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 ASSAY AND CALIBRATORS
K962519 · Behring Diagnostics, Inc. · Sep 1996