Cleared Traditional

K854184 - IN-VITRO TEST DETERMINATION OF TOBRAMYCIN

K854184 is the FDA 510(k) clearance for IN-VITRO TEST DETERMINATION OF TOBRAMYCIN by Clinical Data, Inc.. It is a Class 2 Toxicology device (product code KLB) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K854184 · Clinical Data, Inc. · Toxicology device
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Dec 1985
Decision
50d
Days
Class 2
Risk

K854184 is an FDA 510(k) clearance for the IN-VITRO TEST DETERMINATION OF TOBRAMYCIN. Classified as Radioimmunoassay, Tobramycin (product code KLB), Class II - Special Controls.

Submitted by Clinical Data, Inc. (Boston, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 50 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 Clinical Data, Inc. devices

Submission Details

510(k) Number K854184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1985
Decision Date December 04, 1985
Days to Decision 50 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 87d · This submission: 50d
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 K854184.
TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD
K893913 · Technicon Instruments Corp. · Aug 1989
EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY
K882294 · Syva Co. · Jul 1988
EMIT TOBRAMYCIN ASSAY
K874223 · Syva Co. · Nov 1987
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