Cleared Traditional

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B (K041928) - FDA 510(k) Clearance

Class I Chemistry device.

K041928 · Diagnostic Chemicals , Ltd. · Chemistry device
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Nov 2004
Decision
127d
Days
Class 1
Risk

K041928 is an FDA 510(k) clearance for the HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on November 23, 2004 after a review of 127 days - within the typical 510(k) review window.

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 Diagnostic Chemicals , Ltd. devices

Submission Details

510(k) Number K041928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2004
Decision Date November 23, 2004
Days to Decision 127 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
39d slower than avg
Panel avg: 88d · This submission: 127d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K041928.
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ULTRA HDL
K051962 · Abbott Laboratories · Aug 2005
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
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003