Cleared Traditional

K962819 - GENTAMICIN FLEX REAGENT CARTRIDGE

K962819 is an FDA 510(k) clearance for GENTAMICIN FLEX REAGENT CARTRIDGE, manufactured by Dade Intl., Inc.. The device is a Class 2 Toxicology device with product code LCD cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K962819 · 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

K962819 is an FDA 510(k) clearance for the GENTAMICIN FLEX REAGENT CARTRIDGE. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), 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 862.3450 - 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 Dade Intl., Inc. devices

FDA 510(k) Submission Details - K962819

510(k) Number K962819 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.

LCD Device Classification - Class 2, Special Controls

Product Code LCD Enzyme 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 - LCD Enzyme Immunoassay, Gentamicin

All 35
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K962819.
RANDOX GENTAMICIN
K012978 · Randox Laboratories, Ltd. · Sep 2001
IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
K012311 · Diagnostic Products Corp. · Aug 2001
EMIT 2000 GENTAMICIN PLUS ASSAY
K010984 · Syva Co., Dade Behring, Inc. · Apr 2001
EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
K962519 · Behring Diagnostics, Inc. · Sep 1996
ACS GENTAMICIN
K953020 · Ciba Corning Diagnostics Corp. · Aug 1995
IL TEST GENTAMICIN CALIBRATORS
K943982 · Instrumentation Laboratory CO · Jan 1995