Cleared Traditional

K021316 - ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT...

Also marketed or referenced as:
ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR

K021316 is the FDA 510(k) clearance for ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT... by Genzyme Corp.. It is a Class 1 Chemistry device (product code LBS) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K021316 · Genzyme Corp. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
91d
Days
Class 1
Risk

K021316 is an FDA 510(k) clearance for the ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2. Classified as Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (product code LBS), Class I - General Controls.

Submitted by Genzyme Corp. (Cambridge, US). The FDA issued a Cleared decision on July 25, 2002 after a review of 91 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 Genzyme Corp. devices

Submission Details

510(k) Number K021316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2002
Decision Date July 25, 2002
Days to Decision 91 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 88d · This submission: 91d
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 48
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K021316.
SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT
K040767 · Beckman Coulter, Inc. · Jun 2004
DIRECT HDL-CHOLESTEROL LIQUID COLOR
K032932 · Stanbio Laboratory · Mar 2004
HDL-CHOLESTEROL PLUS 2ND GENERATION
K033610 · Roche Diagnostics Corp. · Dec 2003
OLYMPUS HDL CHOLESTEROL REAGENT
K014015 · Olympus America, Inc. · Feb 2002
OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA
K014032 · Olympus America, Inc. · Feb 2002
MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION
K012286 · Roche Diagnostics Corp. · Aug 2001