Cleared Traditional

TOBRAMYCIN RIA KIT (K760967) - FDA 510(k) Clearance

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

K760967 · Diagnostic Products Corp. · Immunology device
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Dec 1976
Decision
48d
Days
Class 2
Risk

K760967 is an FDA 510(k) clearance for the TOBRAMYCIN RIA KIT. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1976 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 862.3900 - 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K760967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1976
Decision Date December 22, 1976
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 104d · This submission: 48d
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 Immunology devices follow this clearance model.

Regulatory Peers - KLB Radioimmunoassay, Tobramycin

All 22
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K760967.
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
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K874223 · Syva Co. · Nov 1987
MACRO-VUE CARD TEST
K810597 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1981