Cleared Traditional

K935376 - AXSYM GENTAMICIN

K935376 is an FDA 510(k) clearance for AXSYM GENTAMICIN, manufactured by Abbott Mfg., Inc.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 225-day FDA review.

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

FDA 510(k) Submission Details - K935376

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.

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 K935376.
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · Behring Diagnostics, Inc. · Sep 1996
ACS GENTAMICIN
K953020 · Ciba Corning Diagnostics Corp. · Aug 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995
QMS GENTAMICIN ASSAY
K940376 · Seradyn, Inc. · Jun 1994
CEDIA(R) GENTAMICIN ASSAY
K913470 · Microgenics Corp. · Sep 1991
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990