Cleared Traditional

CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (K880199) - FDA 510(k) Clearance

Class I Chemistry device.

K880199 · Sclavo, Inc. · Chemistry device
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Jan 1989
Decision
380d
Days
Class 1
Risk

K880199 is an FDA 510(k) clearance for the CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on January 27, 1989 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3240 - the FDA in vitro diagnostics and chemistry 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sclavo, Inc. devices

Submission Details

510(k) Number K880199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date January 27, 1989
Days to Decision 380 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
292d slower than avg
Panel avg: 88d · This submission: 380d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DIH Colorimetry, Cholinesterase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.3240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DIH Colorimetry, Cholinesterase

All 25
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K880199.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
KODAK EKTACHEM DT SLIDES (CHE)
K913198 · Eastman Kodak Company · Aug 1991
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K912217 · Eastman Kodak Company · Jul 1991
CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE
K885272 · Sigma Chemical Co. · Mar 1989