Cleared Traditional

AMES TDA TM AMIKACIN TEST (K811026) - FDA 510(k) Clearance

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

K811026 · Miles Laboratories, Inc. · Toxicology device
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Apr 1981
Decision
13d
Days
Class 2
Risk

K811026 is an FDA 510(k) clearance for the AMES TDA TM AMIKACIN TEST. Classified as Radioimmunoassay, Amikacin (product code KLQ), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 29, 1981 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3035 - 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 K811026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1981
Decision Date April 29, 1981
Days to Decision 13 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 87d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLQ Radioimmunoassay, Amikacin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3035
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 - KLQ Radioimmunoassay, Amikacin

All 19
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K811026.
COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR
K852317 · Roche Diagnostic Systems, Inc. · Jun 1985
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT QST AMIKACIN ASSAY
K840193 · Syva Co. · Mar 1984
EMIT-AMD AMIKACIN ASSAY
K822657 · Dade Behring, Inc. · Sep 1982
MACRO-VUE CARD TEST, AMIKACIN
K821771 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1982
COAT-A-COUNT AMIKACIN IRA
K820781 · Diagnostic Products Corp. · Apr 1982