Cleared Traditional

K911406 - HDL CHOLESTEROL REAGENT

K911406 is the FDA 510(k) clearance for HDL CHOLESTEROL REAGENT by Genzyme Corp.. It is a Class 1 Chemistry device (product code LBR) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K911406 · Genzyme Corp. · Chemistry device
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May 1991
Decision
54d
Days
Class 1
Risk

K911406 is an FDA 510(k) clearance for the HDL CHOLESTEROL REAGENT. Classified as Ldl & Vldl Precipitation, Hdl (product code LBR), Class I - General Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on May 22, 1991 after a review of 54 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Genzyme Corp. devices

Submission Details

510(k) Number K911406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1991
Decision Date May 22, 1991
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 88d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LBR Ldl & Vldl Precipitation, 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 - LBR Ldl & Vldl Precipitation, Hdl

All 34
Devices cleared under the same product code (LBR) and FDA review panel - the closest regulatory comparables to K911406.
HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)
K931773 · King Diagnostics, Inc. · Aug 1993
SYNERMED HDL CHOLESTLEROL REAGENT KIT
K924427 · Synermed, Inc. · Nov 1992
IL TEST(TM) HDL CHOLESTEROL
K914811 · Instrumentation Laboratory CO · Jan 1992
HDL-CHOLESTEROL PRECIPITANT 7773/7573/7473/7173
K905284 · Amresco, Inc. · Dec 1990
REFLOTRON HDL CHOLESTEROL TEST TABS
K902568 · Boehringer Mannheim Corp. · Aug 1990
COULTER HDL - CHOLESTEROL REAGENT
K902174 · Coulter Corp. · Jul 1990