Cleared Traditional

DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD (K904304) - FDA 510(k) Clearance

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

K904304 · E.I. Dupont DE Nemours & Co., Inc. · Toxicology device
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Oct 1990
Decision
37d
Days
Class 2
Risk

K904304 is an FDA 510(k) clearance for the DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on October 26, 1990 after a review of 37 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K904304 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1990
Decision Date October 26, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 87d · This submission: 37d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLB Radioimmunoassay, 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 - KLB Radioimmunoassay, Tobramycin

All 22
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K904304.
ONLINE TDM TOBRAMYCIN
K060853 · Roche Diagnostics Corp. · Jun 2006
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp. · Aug 2001
IL TOBRAMYCIN ASSAY
K903192 · Instrumentation Laboratory CO · Aug 1990
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · Syva Co. · Jul 1988
EMIT TOBRAMYCIN ASSAY
K874223 · Syva Co. · Nov 1987
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985