Cleared Traditional

K941614 - AXSYM TOBRAMYCIN

K941614 is an FDA 510(k) clearance for AXSYM TOBRAMYCIN, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code LFW cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K941614 · Abbott Laboratories · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1994
Decision
136d
Days
Class 2
Risk

K941614 is an FDA 510(k) clearance for the AXSYM TOBRAMYCIN. Classified as Fluorescence Polarization Immunoassay, Tobramycin (product code LFW), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 18, 1994 after a review of 136 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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 Laboratories devices

FDA 510(k) Submission Details - K941614

510(k) Number K941614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1994
Decision Date August 18, 1994
Days to Decision 136 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
49d slower than avg
Panel avg: 87d · This submission: 136d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFW Device Classification - Class 2, Special Controls

Product Code LFW Fluorescence Polarization Immunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 - LFW Fluorescence Polarization Immunoassay, Tobramycin

Devices cleared under the same product code (LFW) and FDA review panel - the closest regulatory comparables to K941614.
ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN
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K944371 · Sigma Diagnostics, Inc. · Nov 1994
CEDIA(R) TOBRAMYCIN ASSAY
K912143 · Microgenics Corp. · Jul 1991
MODIFIED ACCUFLUOR TOBRAMYCIN REAGENT & CALIBRATOR
K900707 · Innotron of Oregon, Inc. · Apr 1990
INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET
K872562 · Innotron of Oregon, Inc. · Aug 1987
COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
K843828 · Roche Diagnostic Systems, Inc. · Feb 1985