Cleared Traditional

K002792 - CARESIDE CHOLINESTERASE

K002792 is the FDA 510(k) clearance for CARESIDE CHOLINESTERASE by Careside, Inc.. It is a Class 1 Chemistry device (product code DIH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K002792 · Careside, Inc. · Chemistry device
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Nov 2000
Decision
62d
Days
Class 1
Risk

K002792 is an FDA 510(k) clearance for the CARESIDE CHOLINESTERASE. Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on November 8, 2000 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Careside, Inc. devices

Submission Details

510(k) Number K002792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2000
Decision Date November 08, 2000
Days to Decision 62 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 88d · This submission: 62d
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 17
Devices cleared under the same product code (DIH) and FDA review panel - the closest regulatory comparables to K002792.
SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722
K103373 · Beckman Coulter, Inc. · Feb 2011
CHOLINESTERASE GEN.2 TEST SYSTEM
K061093 · Roche Diagnostics Corp. · Jul 2006
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · Olympus America, Inc. · Feb 2003
ADVIA IMS
K001344 · Bayer Corp. · Jun 2000
IL TEST CHOLINESTERASE
K943367 · Instrumentation Laboratory CO · Feb 1996
CHOLINESTERASE ASSAY KIT, CATALOGUE# 300-05
K955498 · Diagnostic Chemicals , Ltd. · Jan 1996