Cleared Traditional

K791502 - QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO

K791502 is the FDA 510(k) clearance for QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO by Bio-Rad. It is a Class 2 Toxicology device (product code KLB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K791502 · Bio-Rad · Toxicology device
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Sep 1979
Decision
27d
Days
Class 2
Risk

K791502 is an FDA 510(k) clearance for the QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Bio-Rad (Mchenry, US). The FDA issued a Cleared decision on September 4, 1979 after a review of 27 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3900 - 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 K791502 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1979
Decision Date September 04, 1979
Days to Decision 27 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
60d faster than avg
Panel avg: 87d · This submission: 27d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLB Radioimmunoassay, Tobramycin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3900
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 - KLB Radioimmunoassay, Tobramycin

All 16
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K791502.
KALLESTAD ANTISERA TO TOBRAMYCIN
K812415 · Kallestad Laboratories, Inc. · Sep 1981
MACRO-VUE CARD TEST
K810597 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981
FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY
K791596 · Bio-Rad · Oct 1979
AMES TDA/TOBRAMYCIN
K791435 · Miles Laboratories, Inc. · Aug 1979
TOBRAMYCIN RIA KIT
K760967 · Diagnostic Products Corp. · Dec 1976