Cleared Traditional

AXSYM GENTAMICIN (K935376) - FDA 510(k) Clearance

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

K935376 · Abbott Mfg., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1994
Decision
225d
Days
Class 2
Risk

K935376 is an FDA 510(k) clearance for the AXSYM GENTAMICIN. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Abbott Mfg., Inc. (Abbott Park, US). The FDA issued a Cleared decision on June 21, 1994 after a review of 225 days - an extended review cycle.

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 Abbott Mfg., Inc. devices

Submission Details

510(k) Number K935376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 1993
Decision Date June 21, 1994
Days to Decision 225 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
138d slower than avg
Panel avg: 87d · This submission: 225d
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 K935376.
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