Cleared Traditional

EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641 (K881116) - FDA 510(k) Clearance

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

K881116 · Diagnostic Systems · Toxicology device
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Jun 1988
Decision
97d
Days
Class 2
Risk

K881116 is an FDA 510(k) clearance for the EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641. Classified as Enzyme Immunoassay, Lidocaine (product code KLR), Class II - Special Controls.

Submitted by Diagnostic Systems (Gibbstown, US). The FDA issued a Cleared decision on June 20, 1988 after a review of 97 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3555 - 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 Diagnostic Systems devices

Submission Details

510(k) Number K881116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date June 20, 1988
Days to Decision 97 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 87d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLR Enzyme Immunoassay, Lidocaine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3555
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 - KLR Enzyme Immunoassay, Lidocaine

All 16
Devices cleared under the same product code (KLR) and FDA review panel - the closest regulatory comparables to K881116.
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ROCHE ONLINE TDM LIDOCAINE
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COBAS REAGENT FOR LIDOCAINE & CALIBRATORS
K853010 · Roche Diagnostic Systems, Inc. · Aug 1985
LIDOCAINE ANALYTICAL TEST PACK ACA
K833379 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
VALPROIC ACID ANALYTICAL TEST PACK
K833381 · E.I. Dupont DE Nemours & Co., Inc. · Dec 1983
MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY
K833623 · Syva Co. · Dec 1983