Cleared Traditional

K780516 - GENTAMICIN RIA KIT

K780516 is the FDA 510(k) clearance for GENTAMICIN RIA KIT by Antibodies, Inc.. It is a Class 2 Immunology device (product code DJB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K780516 · Antibodies, Inc. · Immunology device
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Apr 1978
Decision
29d
Days
Class 2
Risk

K780516 is an FDA 510(k) clearance for the GENTAMICIN RIA KIT. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Antibodies, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 28, 1978 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3450 - the FDA immunology 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 Antibodies, Inc. devices

Submission Details

510(k) Number K780516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1978
Decision Date April 28, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 104d · This submission: 29d
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 Immunology devices follow this clearance model.

Regulatory Peers - DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

All 14
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K780516.
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
QUANTITOPE 125-I GENTAMICIN RIA KIT
K780323 · Kallestad Laboratories, Inc. · Mar 1978
AMINOGLYCOSIDE (125I) RIA KIT
K761157 · Diagnostic Products Corp. · Mar 1977