Cleared Special

OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296 (K040471) - FDA 510(k) Clearance

Also marketed or referenced as:
OLYMPUS LDL CHOLESTEROL CALIBRATOR, ODC0024

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

K040471 · Olympus America, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 2004
Decision
15d
Days
Class 2
Risk

K040471 is an FDA 510(k) clearance for the OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Olympus America, Inc. (Irving, US). The FDA issued a Cleared decision on March 10, 2004 after a review of 15 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Olympus America, Inc. devices

Submission Details

510(k) Number K040471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2004
Decision Date March 10, 2004
Days to Decision 15 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 88d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code JIT Calibrator, Secondary
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.

Regulatory Peers - JIT Calibrator, Secondary

All 82
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K040471.
ROCHE DIAGNOSTICS ELECSYS AFP CALSET II
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FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS
K042651 · Beckman Coulter, Inc. · Oct 2004
ELECSYS FOLATE II CALSET II
K042490 · Roche Diagnostics Corp. · Sep 2004
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · Abbott Laboratories · Oct 2003
ELECSYS LH CALSET II
K031299 · Roche Diagnostics Corp. · May 2003
DIMENSION TPSA CALIBRATOR, MODEL #RC459
K020980 · Dade Behring, Inc. · Jun 2002