Cleared Traditional

K790829 - EMIT GENTAMICIN ASSAY

K790829 is the FDA 510(k) clearance for EMIT GENTAMICIN ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DJB) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K790829 · Syva Co. · Toxicology device
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May 1979
Decision
15d
Days
Class 2
Risk

K790829 is an FDA 510(k) clearance for the EMIT GENTAMICIN ASSAY. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on May 15, 1979 after a review of 15 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 Syva Co. devices

Submission Details

510(k) Number K790829 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1979
Decision Date May 15, 1979
Days to Decision 15 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
72d faster than avg
Panel avg: 87d · This submission: 15d
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 K790829.
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · Bio-Rad · Oct 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · Abbott Laboratories · Aug 1979
AMES TDA/GENTGMICIN
K790584 · Miles Laboratories, Inc. · Jun 1979
RIA KIT, SISOMICIN
K782126 · Diagnostic Products Corp. · Feb 1979
MACRO-VUE TEST, GENTAMICIN
K781674 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1978
AMINOGLYCOSIDE TEST SYSTEM
K772116 · Nichols Institute Diagnostics · Apr 1978