Cleared Traditional

VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS (K042479) - FDA 510(k) Clearance

Also marketed or referenced as:
VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14 VITROS CHE

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K042479 · Ortho-Clinical Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
115d
Days
Class 2
Risk

K042479 is an FDA 510(k) clearance for the VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics, Inc. (Rochester, US). The FDA issued a Cleared decision on January 6, 2005 after a review of 115 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 Ortho-Clinical Diagnostics, Inc. devices

Submission Details

510(k) Number K042479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date January 06, 2005
Days to Decision 115 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 87d · This submission: 115d
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 36
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K042479.
ARCHITECT iGentamicin
K243500 · Abbott Laboratories · Jul 2025
ARCHITECT IGENTAMICIN REAGENTS
K102699 · Abbott Laboratories · Apr 2011
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
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990