Cleared Traditional

K813516 - MRI TOBRAMYCIN RIA KIT

K813516 is the FDA 510(k) clearance for MRI TOBRAMYCIN RIA KIT by Microanalytic Research, Inc.. It is a Class 2 Microbiology device (product code KLB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K813516 · Microanalytic Research, Inc. · Microbiology device
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Dec 1981
Decision
14d
Days
Class 2
Risk

K813516 is an FDA 510(k) clearance for the MRI TOBRAMYCIN RIA KIT. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Microanalytic Research, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.3900 - the FDA microbiology 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 Microanalytic Research, Inc. devices

Submission Details

510(k) Number K813516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1981
Decision Date December 29, 1981
Days to Decision 14 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 102d · This submission: 14d
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 Microbiology devices follow this clearance model.

Regulatory Peers - KLB Radioimmunoassay, Tobramycin

All 17
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K813516.
ACA TOBRAMY-CIN ANALYTICAL TEST PACK
K852671 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1985
TOBRAMYCIN ANALYTICAL TEST PACK-ACA
K832985 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1983
COAT-A-COUNT TOBRAMYCIN RIA KIT
K822858 · Diagnostic Products Corp. · Oct 1982
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