Cleared Traditional

K962818 - TOBRAMYCIN FLEX REAGENT CARTRIDGE

K962818 is an FDA 510(k) clearance for TOBRAMYCIN FLEX REAGENT CARTRIDGE, manufactured by Dade Intl., Inc.. The device is a Class 2 Toxicology device with product code LCR cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K962818 · Dade Intl., Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
56d
Days
Class 2
Risk

K962818 is an FDA 510(k) clearance for the TOBRAMYCIN FLEX REAGENT CARTRIDGE. Classified as Fluorescent Immunoassay, Tobramycin (product code LCR), Class II - Special Controls.

Submitted by Dade Intl., Inc. (Newark, US). The FDA issued a Cleared decision on September 13, 1996 after a review of 56 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 Dade Intl., Inc. devices

FDA 510(k) Submission Details - K962818

510(k) Number K962818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1996
Decision Date September 13, 1996
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LCR Device Classification - Class 2, Special Controls

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 15
Devices cleared under the same product code (LCR) and FDA review panel - the closest regulatory comparables to K962818.
QMS TOBRAMYCIN
K060998 · Seradyn, Inc. · Jul 2006
ACS TOBRAMYCIN
K974029 · Chiron Diagnostics Corp. · Feb 1998
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
K952568 · Beckman Instruments, Inc. · Aug 1995
OPUS(R) TOBRAMYCIN
K911940 · Pb Diagnostic Systems, Inc. · Jul 1991
VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4
K911613 · Exmoor Plastics , Ltd. · Jun 1991
INTRAOCULAR PRESSURE REDUCER
K854873 · Mira, Inc. · Feb 1986