Cleared Traditional

QUANTITOPE 125-I GENTAMICIN RIA KIT (K780323) - FDA 510(k) Clearance

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

K780323 · Kallestad Laboratories, Inc. · Immunology device
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Mar 1978
Decision
18d
Days
Class 2
Risk

K780323 is an FDA 510(k) clearance for the QUANTITOPE 125-I GENTAMICIN RIA KIT. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 17, 1978 after a review of 18 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K780323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1978
Decision Date March 17, 1978
Days to Decision 18 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 104d · This submission: 18d
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 18
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K780323.
GENTAMICIN TEST PACK-ACA
K831210 · E.I. Dupont DE Nemours & Co., Inc. · May 1983
COAT-A-COUNT GENTAMICIN RIA KIT
K811844 · Diagnostic Products Corp. · Jul 1981
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