Cleared Special

K040692 - OLYMPUS HDL CHOLESTEROL REAGENT

K040692 is the FDA 510(k) clearance for OLYMPUS HDL CHOLESTEROL REAGENT by Olympus America, Inc.. It is a Class 2 Chemistry device (product code JIT) cleared through the Special 510(k) pathway after a 22-day FDA review.

K040692 · Olympus America, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
22d
Days
Class 2
Risk

K040692 is an FDA 510(k) clearance for the OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL .... 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 April 8, 2004 after a review of 22 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 K040692 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date April 08, 2004
Days to Decision 22 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
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 165
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K040692.
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
AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
K033860 · Wako Chemicals USA, Inc. · Apr 2004
WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
K040226 · Wako Chemicals USA, Inc. · Mar 2004
OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296
K040471 · Olympus America, Inc. · Mar 2004
ABBOTT ARCHITECT ESTRADIOL CALIBRATORS
K032458 · Abbott Laboratories · Oct 2003