Cleared Traditional

K030045 - OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) (FDA 510(k) Clearance)

Class I Chemistry device.

K030045 · Olympus America, Inc. · Chemistry device
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Feb 2003
Decision
46d
Days
Class 1
Risk

K030045 is an FDA 510(k) clearance for the OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114). Classified as Colorimetry, Cholinesterase (product code DIH), Class I - General Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on February 21, 2003 after a review of 46 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 Olympus America, Inc. devices

Submission Details

510(k) Number K030045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date February 21, 2003
Days to Decision 46 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 88d · This submission: 46d
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.