Cleared Traditional

K041090 - HDL-EX SEIKEN ASSAY KIT

K041090 is an FDA 510(k) clearance for HDL-EX SEIKEN ASSAY KIT, manufactured by Denka Seiken Co., Ltd.. The device is a Class 1 Chemistry device with product code LBS cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K041090 · Denka Seiken Co., Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
186d
Days
Class 1
Risk

K041090 is an FDA 510(k) clearance for the HDL-EX SEIKEN ASSAY KIT. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Denka Seiken Co., Ltd. (Niigata, JP). The FDA issued a Cleared decision on October 29, 2004 after a review of 186 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1475 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Denka Seiken Co., Ltd. devices

FDA 510(k) Submission Details - K041090

510(k) Number K041090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2004
Decision Date October 29, 2004
Days to Decision 186 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 88d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

LBS Device Classification - Class 1, General Controls

Product Code LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1475
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 - LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 71
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K041090.
ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
ADVIA IMS DIRECT HDL CHOLESTEROL ASSAY
K050632 · Bayer Healthcare, LLC · May 2005
HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B
K041928 · Diagnostic Chemicals , Ltd. · Nov 2004
VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE
K042006 · Ortho-Clinical Diagnostics, Inc. · Oct 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747
K042195 · Beckman Coulter, Inc. · Sep 2004
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · Beckman Coulter, Inc. · Jun 2004