Cleared Traditional

BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT (K952568) - FDA 510(k) Clearance

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

K952568 · Beckman Instruments, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 1995
Decision
64d
Days
Class 2
Risk

K952568 is an FDA 510(k) clearance for the BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 8, 1995 after a review of 64 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 Beckman Instruments, Inc. devices

Submission Details

510(k) Number K952568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1995
Decision Date August 08, 1995
Days to Decision 64 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 87d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LCR Fluorescent Immunoassay, 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 - LCR Fluorescent Immunoassay, Tobramycin

Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K952568.
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
K832408 · American Dade · Aug 1983
ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY
K820130 · Syva Co. · Feb 1982
AMES TDA TOBRAMYCIN TEST
K810941 · Miles Laboratories, Inc. · Apr 1981
CYBREX TOBRAMYCIN
K802668 · Abbott Laboratories · Nov 1980