Cleared Traditional

ARCHITECT IGENTAMICIN REAGENTS (K102699) - FDA 510(k) Clearance

Also marketed or referenced as:
ARCHITECT IGENTAMICIN CALIBRATORS

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

K102699 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
193d
Days
Class 2
Risk

K102699 is an FDA 510(k) clearance for the ARCHITECT IGENTAMICIN REAGENTS. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 1, 2011 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abbott Laboratories devices

Submission Details

510(k) Number K102699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2010
Decision Date April 01, 2011
Days to Decision 193 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
106d slower than avg
Panel avg: 87d · This submission: 193d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K102699.
ARCHITECT iGentamicin
K243500 · Abbott Laboratories · Jul 2025
ROCHE ONLINE GENTAMICIN
K020704 · Roche Diagnostics Corp. · Jul 2002
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 ASSAY AND CALIBRATORS
K962519 · Behring Diagnostics, Inc. · Sep 1996
ACS GENTAMICIN
K953020 · Ciba Corning Diagnostics Corp. · Aug 1995