Cleared Traditional

K943982 - IL TEST GENTAMICIN CALIBRATORS

K943982 is the FDA 510(k) clearance for IL TEST GENTAMICIN CALIBRATORS by Instrumentation Laboratory CO. It is a Class 2 Toxicology device (product code LCD) cleared through the Traditional 510(k) pathway after a 232-day FDA review.

K943982 · Instrumentation Laboratory CO · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1995
Decision
232d
Days
Class 2
Risk

K943982 is an FDA 510(k) clearance for the IL TEST GENTAMICIN CALIBRATORS. Classified as Enzyme Immunoassay, Gentamicin (product code LCD), Class II - Special Controls.

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on January 25, 1995 after a review of 232 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 Instrumentation Laboratory CO devices

Submission Details

510(k) Number K943982 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1994
Decision Date January 25, 1995
Days to Decision 232 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
145d slower than avg
Panel avg: 87d · This submission: 232d
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 28
Devices cleared under the same product code (LCD) and FDA review panel - the closest regulatory comparables to K943982.
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
CEDIA(R) GENTAMICIN ASSAY
K913470 · Microgenics Corp. · Sep 1991
DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD
K904305 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1990
IL GENTAMICIN ASSAY SYSTEM
K903743 · Instrumentation Laboratory CO · Sep 1990