Cleared Traditional

K911940 - OPUS TOBRAMYCIN

K911940 is the FDA 510(k) clearance for OPUS TOBRAMYCIN by Pb Diagnostic Systems, Inc.. It is a Class 2 Toxicology device (product code LCR) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K911940 · Pb Diagnostic Systems, Inc. · Toxicology device
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Jul 1991
Decision
61d
Days
Class 2
Risk

K911940 is an FDA 510(k) clearance for the OPUS(R) TOBRAMYCIN. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on July 1, 1991 after a review of 61 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 Pb Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K911940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1991
Decision Date July 01, 1991
Days to Decision 61 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 87d · This submission: 61d
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

All 10
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K911940.
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · Beckman Instruments, Inc. · Aug 1995
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · Exmoor Plastics , Ltd. · Jun 1991
DU PONT TOBRAMYCIN ASSAY REAGENTS
K850058 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1985
STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM
K832408 · American Dade · Aug 1983
NEEDLE HOLDERS
K822197 · Kelleher Corp. · Aug 1982
VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA
K821542 · Electro-Nucleonics Laboratories, Inc. · Jun 1982