Cleared Traditional

QUANTIMUNE GENTAMICIN RIA GENTAMICIN (K791770) - FDA 510(k) Clearance

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

K791770 · Bio-Rad · Toxicology device
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Oct 1979
Decision
40d
Days
Class 2
Risk

K791770 is an FDA 510(k) clearance for the QUANTIMUNE GENTAMICIN RIA GENTAMICIN. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on October 17, 1979 after a review of 40 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 Bio-Rad devices

Submission Details

510(k) Number K791770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1979
Decision Date October 17, 1979
Days to Decision 40 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
47d faster than avg
Panel avg: 87d · This submission: 40d
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 18
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K791770.
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
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