Cleared Traditional

ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2 (K021316) - FDA 510(k) Clearance

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

Class I Chemistry device.

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 79
Devices cleared under the same product code (LBS) and FDA review panel - the closest regulatory comparables to K021316.
HDL CHOLESTEROL (HDLX) ASSAY
K100010 · Beckman Coulter, Inc. · May 2010
AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A
K053157 · Dade Behring, Inc. · Dec 2005
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