Cleared Traditional

KALLESTAD ANTISERA TO TOBRAMYCIN (K812415) - FDA 510(k) Clearance

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

K812415 · Kallestad Laboratories, Inc. · Microbiology device
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Sep 1981
Decision
9d
Days
Class 2
Risk

K812415 is an FDA 510(k) clearance for the KALLESTAD ANTISERA TO TOBRAMYCIN. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Kallestad Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 9 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 Kallestad Laboratories, Inc. devices

Submission Details

510(k) Number K812415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1981
Decision Date September 09, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 102d · This submission: 9d
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 22
Devices cleared under the same product code (KLB) and FDA review panel - the closest regulatory comparables to K812415.
ONLINE TDM TOBRAMYCIN
K060853 · Roche Diagnostics Corp. · Jun 2006
IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS)
K012312 · Diagnostic Products Corp. · Aug 2001
DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD
K904304 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
IL TOBRAMYCIN ASSAY
K903192 · Instrumentation Laboratory CO · Aug 1990
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · Syva Co. · Jul 1988
EMIT TOBRAMYCIN ASSAY
K874223 · Syva Co. · Nov 1987