Cleared Traditional

AMES TDA/TOBRAMYCIN (K791435) - FDA 510(k) Clearance

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

K791435 · Miles Laboratories, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
16d
Days
Class 2
Risk

K791435 is an FDA 510(k) clearance for the AMES TDA/TOBRAMYCIN. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 16 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K791435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1979
Decision Date August 16, 1979
Days to Decision 16 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 87d · This submission: 16d
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 K791435.
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
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
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