Cleared Abbreviated

K043460 - OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K043460 · Olympus America, Inc. · Chemistry device
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Jan 2005
Decision
47d
Days
Class 2
Risk

K043460 is an FDA 510(k) clearance for the OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071. Classified as Calibrator, Multi-analyte Mixture (product code JIX), Class II - Special Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on January 31, 2005 after a review of 47 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K043460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2004
Decision Date January 31, 2005
Days to Decision 47 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 88d · This submission: 47d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code JIX Calibrator, Multi-analyte Mixture
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 Chemistry devices follow this clearance model.