Cleared Traditional

K810941 - AMES TDA TOBRAMYCIN TEST

K810941 is the FDA 510(k) clearance for AMES TDA TOBRAMYCIN TEST by Miles Laboratories, Inc.. It is a Class 2 Toxicology device (product code LCR) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K810941 · Miles Laboratories, Inc. · Toxicology device
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Apr 1981
Decision
10d
Days
Class 2
Risk

K810941 is an FDA 510(k) clearance for the AMES TDA TOBRAMYCIN TEST. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 17, 1981 after a review of 10 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 K810941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1981
Decision Date April 17, 1981
Days to Decision 10 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
77d faster than avg
Panel avg: 87d · This submission: 10d
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 10
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K810941.
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · Electro-Nucleonics Laboratories, Inc. · Jun 1982
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130 · Syva Co. · Feb 1982
TOBRAMYCIN FLUORESCENT IMMUNOASSAY
K813542 · American Diagnostic Corp. · Jan 1982
CYBREX TOBRAMYCIN
K802668 · Abbott Laboratories · Nov 1980