Cleared Traditional

K905721 - OPUS GENTAMICIN

K905721 is an FDA 510(k) clearance for OPUS GENTAMICIN, manufactured by Pb Diagnostic Systems, Inc.. The device is a Class 2 Toxicology device with product code LCQ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K905721 · Pb Diagnostic Systems, Inc. · Toxicology device
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Feb 1991
Decision
62d
Days
Class 2
Risk

K905721 is an FDA 510(k) clearance for the OPUS GENTAMICIN. Classified as Fluorescent Immunoassay Gentamicin (product code LCQ), Class II - Special Controls.

Submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on February 21, 1991 after a review of 62 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3450 - 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

FDA 510(k) Submission Details - K905721

510(k) Number K905721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date February 21, 1991
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCQ Device Classification - Class 2, Special Controls

Product Code LCQ Fluorescent Immunoassay Gentamicin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 - LCQ Fluorescent Immunoassay Gentamicin

All 12
Devices cleared under the same product code (LCQ) and FDA review panel - the closest regulatory comparables to K905721.
INNOFLUOR GENTAMICIN ASSAY SYSTEM
K955569 · Oxis Intl., Inc. · Feb 1996
COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS
K945523 · Roche Diagnostic Systems, Inc. · Mar 1995
GENTAMICIN FPIA REAGENT SET AND CALIBRATORS
K943550 · Sigma Diagnostics, Inc. · Nov 1994
'TDXFLX ANALYZER
K904226 · Abbott Laboratories · Oct 1990
GENTAMICIN KIT(FPIA)
K852013 · Windsor Laboratories, Inc. · Jun 1985
COBAS REAGENTS FOR GENTAMICIN & CALIBRAT
K843827 · Roche Diagnostic Systems, Inc. · Feb 1985