Cleared Traditional

K790584 - AMES TDA/GENTGMICIN

K790584 is the FDA 510(k) clearance for AMES TDA/GENTGMICIN by Miles Laboratories, Inc.. It is a Class 2 Toxicology device (product code DJB) cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K790584 · Miles Laboratories, Inc. · Toxicology device
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Jun 1979
Decision
80d
Days
Class 2
Risk

K790584 is an FDA 510(k) clearance for the AMES TDA/GENTGMICIN. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on June 15, 1979 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - 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 K790584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1979
Decision Date June 15, 1979
Days to Decision 80 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
7d faster than avg
Panel avg: 87d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 - DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

All 13
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K790584.
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770 · Bio-Rad · Oct 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · Bio-Rad · Oct 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · Abbott Laboratories · Aug 1979
EMIT GENTAMICIN ASSAY
K790829 · Syva Co. · May 1979
RIA KIT, SISOMICIN
K782126 · Diagnostic Products Corp. · Feb 1979
MACRO-VUE TEST, GENTAMICIN
K781674 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978