Cleared Traditional

ATYPICAL CHOLINESTERASE (K873496) - FDA 510(k) Clearance

Class I Chemistry device.

K873496 · Sclavo, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1989
Decision
528d
Days
Class 1
Risk

K873496 is an FDA 510(k) clearance for the ATYPICAL CHOLINESTERASE. 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 528 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Sclavo, Inc. devices

Submission Details

510(k) Number K873496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1987
Decision Date January 27, 1989
Days to Decision 528 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
440d slower than avg
Panel avg: 88d · This submission: 528d
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 K873496.
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