Cleared Traditional

K945523 - COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS

K945523 is an FDA 510(k) clearance for COBAS-FP REAGENTS FOR GENTAMICIN AND CO..., manufactured by Roche Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K945523 · Roche Diagnostic Systems, Inc. · Toxicology device
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Mar 1995
Decision
119d
Days
Class 2
Risk

K945523 is an FDA 510(k) clearance for the COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Somerville, US). The FDA issued a Cleared decision on March 9, 1995 after a review of 119 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 Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K945523

510(k) Number K945523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 1994
Decision Date March 09, 1995
Days to Decision 119 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 87d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCQ Device Classification - Class 2, Special Controls

Product Code LCQ Fluorescent 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 - LCQ Fluorescent Immunoassay Gentamicin

All 12
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K945523.
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad · Aug 1997
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · Oxis Intl., Inc. · Feb 1996
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · Sigma Diagnostics, Inc. · Nov 1994
OPUS GENTAMICIN
K905721 · Pb Diagnostic Systems, Inc. · Feb 1991
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
GENTAMICIN KIT(FPIA)
K852013 · Windsor Laboratories, Inc. · Jun 1985