Cleared Traditional

ACS TOBRAMYCIN (K974029) - FDA 510(k) Clearance

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

K974029 · Chiron Diagnostics Corp. · Toxicology device
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Feb 1998
Decision
112d
Days
Class 2
Risk

K974029 is an FDA 510(k) clearance for the ACS TOBRAMYCIN. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Chiron Diagnostics Corp. (Medfield, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 112 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 Chiron Diagnostics Corp. devices

Submission Details

510(k) Number K974029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1997
Decision Date February 12, 1998
Days to Decision 112 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
25d slower than avg
Panel avg: 87d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCR Fluorescent 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 - LCR Fluorescent Immunoassay, Tobramycin

All 16
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K974029.
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · Beckman Instruments, Inc. · Aug 1995
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130 · Syva Co. · Feb 1982
CYBREX TOBRAMYCIN
K802668 · Abbott Laboratories · Nov 1980